GlaxoSmithKline (GSK) is collaborating with the government, the Wellcome Trust and the East of England Development Agency (EEDA) to create a new biotechnology science park at the company’s base in Stevenage, with total funding of £38 million.
GSK is contributing £11 million to the park in land and facilities. The Department for Business, Innovation and Skills will invest almost £12 million, the Technology Strategy Board £5 million, the Wellcome Trust almost £6 million and the EEDA £4 million.
The park will aim to attract small, early-stage biotechnology companies, which will have shared access to specialist skills, scientific equipment and expertise to stimulate innovation. It will initially house 25 companies, and it is estimated that 1,500 new jobs will be created. GSK also has plans to further expand capacity at the park in the future.
The new park has been conceived as a competitor to similar sites in Boston, California and North Carolina in the USA.
Building work will begin in early 2010 with companies moving onto the site in 2011.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on GSK, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
Monday, 26 October 2009
UK - CQC Rates More NHS Trusts ‘Excellent’, but Concerns Remain
The Care Quality Commission (CQC) released a report on the performance of NHS trusts on 15th October 2009.
The report, carried out annually, revealed that the NHS is achieving higher standards overall, but that a significant number of trusts are failing to reach key targets.
More than half of Primary Care Trusts (PCTs) achieved scores of ‘excellent’ or ‘good’ for the first time, but fewer acute trusts were given a top rating, with more receiving a ‘fair’ judgement.
In total, 20 trusts were rated ‘weak’ and a further 27 have not reached a score above ‘fair’ on both quality and financial management indicators for the past four years. However, only one trust was judged to be ‘double-weak’ for its quality of care and financial management, compared to six in 2008. This was Barking, Havering and Redbridge Hospitals NHS Trust.
The CQC expressed concern that 63,000 operations were cancelled for non-clinical reasons, but a higher proportion of procedures are now being rearranged within 28 days of the original appointment.
A total of 48 acute trusts failed to meet at least one of the three standards for infection control according to the report, compared to 44 in 2008. However, progress has been made in rates of hospital-acquired infections, such as Clostridium difficile and MRSA, which have both fallen by around a third.
The report also found that 98% of the 19 million patients who visited A&E were seen within four hours of arrival, and more patients are receiving hospital treatment within 18 weeks of referral.
The CQC will soon gain new powers which will allow it to close down any under-achieving trusts. All trusts must be registered with the CQC from 1st April 2010, and must adhere to core standards or risk being refused a licence to operate. Currently, only half of trusts fully comply.
Further reading - An in-depth analysis of the UK pharmaceutical market, including more information on the NHS and the CQC, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
The report, carried out annually, revealed that the NHS is achieving higher standards overall, but that a significant number of trusts are failing to reach key targets.
More than half of Primary Care Trusts (PCTs) achieved scores of ‘excellent’ or ‘good’ for the first time, but fewer acute trusts were given a top rating, with more receiving a ‘fair’ judgement.
In total, 20 trusts were rated ‘weak’ and a further 27 have not reached a score above ‘fair’ on both quality and financial management indicators for the past four years. However, only one trust was judged to be ‘double-weak’ for its quality of care and financial management, compared to six in 2008. This was Barking, Havering and Redbridge Hospitals NHS Trust.
The CQC expressed concern that 63,000 operations were cancelled for non-clinical reasons, but a higher proportion of procedures are now being rearranged within 28 days of the original appointment.
A total of 48 acute trusts failed to meet at least one of the three standards for infection control according to the report, compared to 44 in 2008. However, progress has been made in rates of hospital-acquired infections, such as Clostridium difficile and MRSA, which have both fallen by around a third.
The report also found that 98% of the 19 million patients who visited A&E were seen within four hours of arrival, and more patients are receiving hospital treatment within 18 weeks of referral.
The CQC will soon gain new powers which will allow it to close down any under-achieving trusts. All trusts must be registered with the CQC from 1st April 2010, and must adhere to core standards or risk being refused a licence to operate. Currently, only half of trusts fully comply.
Further reading - An in-depth analysis of the UK pharmaceutical market, including more information on the NHS and the CQC, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
UK - Seven Million at Risk from Diabetes
Seven million people in the UK are at risk of developing diabetes, according to a report from Diabetes UK in October 2009.
Diabetes UK warned that seven million people have prediabetes, also known as impaired glucose regulation. These people are 15 times more likely to develop diabetes, but prediabetes alone can cause long-term damage to the heart and circulatory system, among others.
However, prediabetes can be reversed and the risk can be reduced by 60% simply by adopting a healthier lifestyle.
In September, Diabetes UK revealed that there were 145,000 new cases of diabetes in 2008 alone (see UK - Diabetes Now Affects 5% of the Population).
Further reading - A detailed review of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
Diabetes UK warned that seven million people have prediabetes, also known as impaired glucose regulation. These people are 15 times more likely to develop diabetes, but prediabetes alone can cause long-term damage to the heart and circulatory system, among others.
However, prediabetes can be reversed and the risk can be reduced by 60% simply by adopting a healthier lifestyle.
In September, Diabetes UK revealed that there were 145,000 new cases of diabetes in 2008 alone (see UK - Diabetes Now Affects 5% of the Population).
Further reading - A detailed review of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
USA - Senate Approves Health Reform Bill
The US Senate Finance Committee approved the health reform bill with a 14-9 majority on 13th October 2009.
The bill, drawn up by chairman Senator Max Baucus, proposes a ten-year US$829 billion plan to reduce health costs and provide affordable health insurance, but does not include a government-run, universal health insurance scheme.
The bill will now go through a compromise process with the bill approved by the Senate Health, Education, Labour and Pensions (HELP) Committee in July 2009, before receiving a full vote on the Senate floor.
The Finance panel is the last of five Congressional committees to put forward health reform proposals.
Further reading - An in-depth analysis of the US pharmaceutical market, including some background information on the healthcare system and reform plans, is available from Espicom: The Pharmaceutical Market: USA (published September 2009)
The bill, drawn up by chairman Senator Max Baucus, proposes a ten-year US$829 billion plan to reduce health costs and provide affordable health insurance, but does not include a government-run, universal health insurance scheme.
The bill will now go through a compromise process with the bill approved by the Senate Health, Education, Labour and Pensions (HELP) Committee in July 2009, before receiving a full vote on the Senate floor.
The Finance panel is the last of five Congressional committees to put forward health reform proposals.
Further reading - An in-depth analysis of the US pharmaceutical market, including some background information on the healthcare system and reform plans, is available from Espicom: The Pharmaceutical Market: USA (published September 2009)
Russia - Ban on Promotion of Medicines to Doctors Proposed
Prime Minister Vladimir Putin has proposed that pharmaceutical companies be banned from sending representatives to visit doctors in order to promote the use of their medicines.
At a meeting on the development of the drugs industry on October 9th 2009, Mr. Putin said, “We should get rid of these so-called pharmaceuticals representatives working in medical institutions.” He claimed that Russia has seen the rise of an “abnormal” interaction between pharmaceutical companies, particularly foreign ones, and the medical community over the past ten years.
In Russia, this form of communication is one of the main ways that companies are able to promote their products, and Mr. Putin’s statement has prompted fears that doctors will have no way of finding out about new medicines on the market. Under the law, prescription drugs can only be advertised in certain publications, which not all doctors are able to access.
Pharmaceutical companies spend an estimated 10-15% of their revenue on representatives, which amounts to around the same as production costs. For foreign companies who do not manufacture in Russia, this proportion can rise to as much as 40-50% of revenue.
Many pharmaceutical companies have hit back at the suggestion, claiming that what they are doing is not unethical or illegal. The head of GlaxoSmithKline in Russia, Fabio Landazabal, commented that representatives are not allowed to give doctors presents or money, and cannot hold entertainment or sport events. The drugmakers also asserted that it is in only isolated cases that doctors are paid for such activity.
Further reading - A detailed analysis of the Russian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Russia (published September 2009)
At a meeting on the development of the drugs industry on October 9th 2009, Mr. Putin said, “We should get rid of these so-called pharmaceuticals representatives working in medical institutions.” He claimed that Russia has seen the rise of an “abnormal” interaction between pharmaceutical companies, particularly foreign ones, and the medical community over the past ten years.
In Russia, this form of communication is one of the main ways that companies are able to promote their products, and Mr. Putin’s statement has prompted fears that doctors will have no way of finding out about new medicines on the market. Under the law, prescription drugs can only be advertised in certain publications, which not all doctors are able to access.
Pharmaceutical companies spend an estimated 10-15% of their revenue on representatives, which amounts to around the same as production costs. For foreign companies who do not manufacture in Russia, this proportion can rise to as much as 40-50% of revenue.
Many pharmaceutical companies have hit back at the suggestion, claiming that what they are doing is not unethical or illegal. The head of GlaxoSmithKline in Russia, Fabio Landazabal, commented that representatives are not allowed to give doctors presents or money, and cannot hold entertainment or sport events. The drugmakers also asserted that it is in only isolated cases that doctors are paid for such activity.
Further reading - A detailed analysis of the Russian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Russia (published September 2009)
Sweden - Anti-Counterfeiting System Trials Underway
The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced in October 2009 that trials of an anti-counterfeiting system are underway in Sweden, to try to combat the problem of counterfeit drugs entering the market.
A medicines verification system utilising a small data matrix is being trialled, which alerts the pharmacist immediately if a pack could be counterfeit. The data matrix allows each pack to be individually coded, providing information such as the product code, expiry date, batch number and a serial number which is unique to each pack.
The trial is taking place in conjunction with the retailer Apoteket AB and local wholesalers Tamro and Oriola, in 25 pharmacies in the Stockholm area. A total of 100,000 products will be verified.
The initiative is the response of EFPIA to the European Commission’s proposal for a mass serialisation of medicines as part of measures to better protect EU citizens from the serious threats posed by counterfeit drugs.
The trial will run until the end of November 2009.
Further reading - An in-depth analysis of the Swedish pharmaceutical market is available from Espicom: The Pharmaceutical Market: Sweden (published September 2009)
A medicines verification system utilising a small data matrix is being trialled, which alerts the pharmacist immediately if a pack could be counterfeit. The data matrix allows each pack to be individually coded, providing information such as the product code, expiry date, batch number and a serial number which is unique to each pack.
The trial is taking place in conjunction with the retailer Apoteket AB and local wholesalers Tamro and Oriola, in 25 pharmacies in the Stockholm area. A total of 100,000 products will be verified.
The initiative is the response of EFPIA to the European Commission’s proposal for a mass serialisation of medicines as part of measures to better protect EU citizens from the serious threats posed by counterfeit drugs.
The trial will run until the end of November 2009.
Further reading - An in-depth analysis of the Swedish pharmaceutical market is available from Espicom: The Pharmaceutical Market: Sweden (published September 2009)
EU - EU Commission Raids Pharmaceutical Companies Suspected of Anti-Competitive Behaviour
The EU Commission carried out raids at several pharmaceutical companies on 6th October 2009, as part of its investigation into anti-competitive behaviour within the industry.
Surprise inspections were confirmed at sanofi-aventis, Teva, Novartis and Ranbaxy Laboratories.
This is the third time that the EU Commission has carried out raids. In January 2008, the EU Commission raided the offices of GlaxoSmithKline, AstraZeneca, sanofi-aventis and several generic competitors, and in November 2008, Teva, Servier and Krka Group were all raided.
In a statement the EU Commission said, “The Commission has reason to believe that the provisions of the EC Treaty prohibiting restrictive business practices and/or the abuse of a dominant market position... may have been infringed.”
However the regulators stressed, “The fact that the European Commission carries out such inspections does not mean that the companies are guilty of anti-competitive behaviour nor does it prejudge the outcome of the investigation itself.”
The raids follow an 18-month inquiry into anti-competitive practices within the pharmaceutical industry, the findings of which were released in July 2009 (see EU - Competition Inquiry Findings Released). The inquiry found that at least 200 settlement agreements between generic and originator companies were known, and that many of these were formed to restrict generic entry onto the market.
The European Commission is already investigating Servier and some generic firms on suspicion of blocking a generic copy of the cardiovascular drug perindopril from entering the market.
Further reading - Pharmaceutical market profiles for all European countries are available from Espicom: Pharmaceutical Market Reports; Europe
Surprise inspections were confirmed at sanofi-aventis, Teva, Novartis and Ranbaxy Laboratories.
This is the third time that the EU Commission has carried out raids. In January 2008, the EU Commission raided the offices of GlaxoSmithKline, AstraZeneca, sanofi-aventis and several generic competitors, and in November 2008, Teva, Servier and Krka Group were all raided.
In a statement the EU Commission said, “The Commission has reason to believe that the provisions of the EC Treaty prohibiting restrictive business practices and/or the abuse of a dominant market position... may have been infringed.”
However the regulators stressed, “The fact that the European Commission carries out such inspections does not mean that the companies are guilty of anti-competitive behaviour nor does it prejudge the outcome of the investigation itself.”
The raids follow an 18-month inquiry into anti-competitive practices within the pharmaceutical industry, the findings of which were released in July 2009 (see EU - Competition Inquiry Findings Released). The inquiry found that at least 200 settlement agreements between generic and originator companies were known, and that many of these were formed to restrict generic entry onto the market.
The European Commission is already investigating Servier and some generic firms on suspicion of blocking a generic copy of the cardiovascular drug perindopril from entering the market.
Further reading - Pharmaceutical market profiles for all European countries are available from Espicom: Pharmaceutical Market Reports; Europe
EU - European Court Sides with Drugmakers on Pricing Matter
The European Court of Justice ruled on 6th October 2009 that the EU Commission should reconsider whether efforts by drugmakers to prevent traders from exploiting price differences across Europe should be allowed.
Up until now, the EU Commission has opposed companies changing their prices to compensate for parallel trade. Pharmaceutical companies, however, have complained that this undermines their ability to recover the costs of developing new medicines.
The case involved GlaxoSmithKline, who introduced a policy in the late 1990s to put higher prices on a number of drugs sold in the Spanish market, which it had determined were going to be exported. The EU Commission said that the company was restricting competition within the European Union, having long favoured the creation of a single market for goods, including prescription drugs, with the aim of lowering prices.
Many governments buy medicines in bulk in southern European countries such as Spain, and sell surpluses in northern nations such as the UK, where drugs usually cost more. This type of parallel trade helps to cut the price of medicines for their health services.
The traders were disappointed by the verdict. Andreas Mohringer, the president of the European Association of Euro-Pharmaceutical Companies, which represents the traders, commented, “Allowing the system in Spain to stand would mean competition would suffer in Europe with the losers being national social security systems, taxpayers and patients.”
However, the victory for the pharmaceutical industry could be significant at a time when companies face a great deal of price competition.
Further reading - Detailed reviews of the pharmaceutical markets in all European countries are available from Espicom: Pharmaceutical Market Reports; Europe
Up until now, the EU Commission has opposed companies changing their prices to compensate for parallel trade. Pharmaceutical companies, however, have complained that this undermines their ability to recover the costs of developing new medicines.
The case involved GlaxoSmithKline, who introduced a policy in the late 1990s to put higher prices on a number of drugs sold in the Spanish market, which it had determined were going to be exported. The EU Commission said that the company was restricting competition within the European Union, having long favoured the creation of a single market for goods, including prescription drugs, with the aim of lowering prices.
Many governments buy medicines in bulk in southern European countries such as Spain, and sell surpluses in northern nations such as the UK, where drugs usually cost more. This type of parallel trade helps to cut the price of medicines for their health services.
The traders were disappointed by the verdict. Andreas Mohringer, the president of the European Association of Euro-Pharmaceutical Companies, which represents the traders, commented, “Allowing the system in Spain to stand would mean competition would suffer in Europe with the losers being national social security systems, taxpayers and patients.”
However, the victory for the pharmaceutical industry could be significant at a time when companies face a great deal of price competition.
Further reading - Detailed reviews of the pharmaceutical markets in all European countries are available from Espicom: Pharmaceutical Market Reports; Europe
Friday, 23 October 2009
Japan, Mexico, Turkey, Belgium and Sweden - Takeda to Expand Operations
Takeda Pharmaceutical Co. is establishing four new commercial subsidiaries in Mexico, Turkey, Sweden and Belgium. The Swedish subsidiary will also encompass Norway and Denmark, and the Belgian one will include Luxembourg.
Alan Mackenzie, executive vice president of international operations at Takeda Pharmaceuticals International, said, “Takeda has a significant opportunity to expand our presence in Mexico, Europe and other priority markets. Executing our territory expansion strategy is an important step toward further globalising our operations.”
The Tokyo-headquartered firm has also set up operations in Spain, Portugal, Ireland and Canada in recent months.
Further reading - In-depth reviews of the pharmaceutical markets in Japan, Mexico, Turkey, Sweden and Belgium are available from Espicom: The Pharmaceutical Market: Japan; The Pharmaceutical Market: Mexico; The Pharmaceutical Market: Turkey; The Pharmaceutical Market: Belgium; and The Pharmaceutical Market: Sweden (all published September 2009)
Alan Mackenzie, executive vice president of international operations at Takeda Pharmaceuticals International, said, “Takeda has a significant opportunity to expand our presence in Mexico, Europe and other priority markets. Executing our territory expansion strategy is an important step toward further globalising our operations.”
The Tokyo-headquartered firm has also set up operations in Spain, Portugal, Ireland and Canada in recent months.
Further reading - In-depth reviews of the pharmaceutical markets in Japan, Mexico, Turkey, Sweden and Belgium are available from Espicom: The Pharmaceutical Market: Japan; The Pharmaceutical Market: Mexico; The Pharmaceutical Market: Turkey; The Pharmaceutical Market: Belgium; and The Pharmaceutical Market: Sweden (all published September 2009)
India - Novo Nordisk to Hire More Staff
Novo Nordisk is planning to increase its workforce in India, as the staff are cheaper and the education level is high, it was reported on 26th September 2009.
The Danish company currently has 100 employees in India, and it is planning to increase this to around 500 staff in the next three to five years.
The wage level in India is around 20-40% of a salary in Denmark. However, Novo Nordisk will not reduce its Danish workforce to compensate for more employees in India; instead this will reflect the company’s overall growth.
Further reading - A detailed analysis of the Indian pharmaceutical market, including more information on domestic producers, is available from Espicom: The Pharmaceutical Market: India (published September 2009)
The Danish company currently has 100 employees in India, and it is planning to increase this to around 500 staff in the next three to five years.
The wage level in India is around 20-40% of a salary in Denmark. However, Novo Nordisk will not reduce its Danish workforce to compensate for more employees in India; instead this will reflect the company’s overall growth.
Further reading - A detailed analysis of the Indian pharmaceutical market, including more information on domestic producers, is available from Espicom: The Pharmaceutical Market: India (published September 2009)
China - 2,300 Drug Prices to be cut in October 2009
The price of more than 2,300 medicines are to be cut by an average of 12%, the National Development and Reform Commission (NDRC) announced on 2nd October 2009.
Prices will be cut for around 45% of the essential drugs list. The prices of 49% of medicines on the list will stay the same, while the remaining 6% will have their prices increased to encourage production, as they are currently in short supply. The price changes will come into effect on 22nd October 2009.
The price cuts are being implemented to help people afford essential drugs, and this is part of China’s three-year US$124 billion healthcare reform plan, which aims to provide access to essential healthcare for the entire population by 2010.
The NDRC also announced that state-run basic medical and healthcare facilities will no longer be able to sell medicines at a 15% mark-up, which will reduce prices even more.
The essential medicines list was published in September 2009 (See China - Essential Medicines List Published as Part of Health Reforms).
Further reading - An in-depth analysis of the Chinese pharmaceutical market, including more detailed information on health reforms, is available from Espicom: The Pharmaceutical Market: China (published September 2009)
Prices will be cut for around 45% of the essential drugs list. The prices of 49% of medicines on the list will stay the same, while the remaining 6% will have their prices increased to encourage production, as they are currently in short supply. The price changes will come into effect on 22nd October 2009.
The price cuts are being implemented to help people afford essential drugs, and this is part of China’s three-year US$124 billion healthcare reform plan, which aims to provide access to essential healthcare for the entire population by 2010.
The NDRC also announced that state-run basic medical and healthcare facilities will no longer be able to sell medicines at a 15% mark-up, which will reduce prices even more.
The essential medicines list was published in September 2009 (See China - Essential Medicines List Published as Part of Health Reforms).
Further reading - An in-depth analysis of the Chinese pharmaceutical market, including more detailed information on health reforms, is available from Espicom: The Pharmaceutical Market: China (published September 2009)
UK and China - GSK Invests in Joint Venture to Produce Paediatric Vaccines in China
GlaxoSmithKline has entered into a partnership with Jiangsu Walvax Biotech Company to develop and manufacture paediatric vaccines for use in China.
As part of the deal, GSK will provide the technology for its MMR jab Priorix to Walvax to enable local production and distribution of the vaccine. A manufacturing plant will built specifically so that the joint venture can eventually supply China’s public vaccine market.
The collaboration will be reached with a total investment of £41.2 million, of which GSK is providing £20.1 million to begin with and a further £7.3 million in 2015. Meanwhile, Walvax is investing £13.8 million into the partnership. From these investments, GSK has an equity share of 65% and Walvax 35%, although the companies noted that this can be revised in the future if necessary.
Further reading - Detailed reviews of the pharmaceutical markets in both the UK and China, including more information on pharmaceutical companies, are available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009) and The Pharmaceutical Market: China (published September 2009)
As part of the deal, GSK will provide the technology for its MMR jab Priorix to Walvax to enable local production and distribution of the vaccine. A manufacturing plant will built specifically so that the joint venture can eventually supply China’s public vaccine market.
The collaboration will be reached with a total investment of £41.2 million, of which GSK is providing £20.1 million to begin with and a further £7.3 million in 2015. Meanwhile, Walvax is investing £13.8 million into the partnership. From these investments, GSK has an equity share of 65% and Walvax 35%, although the companies noted that this can be revised in the future if necessary.
Further reading - Detailed reviews of the pharmaceutical markets in both the UK and China, including more information on pharmaceutical companies, are available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009) and The Pharmaceutical Market: China (published September 2009)
UK - NHS in Wales Scrap 22 Local Health Boards
On 1st October 2009, the 22 local health boards in Wales were scrapped, and integrated with NHS trusts to form seven new local health boards. These will control all hospital and community services, in addition to GP and dentist funding. The new boards will also be responsible for meeting hospital targets on waiting times.
The new local health boards are:
The new local health boards are:
- Betsi Cadwallader;
- Hywel Dda;
- Abertawe Bro Morganwg University;
- Powys Teaching;
- Cwm Taf;
- Cardiff and Vale; and
- Aneurin Bevan.
The only NHS trusts to remain are the Welsh Ambulance Service and Velindre Hospital in Cardiff, which specialises in cancer treatment.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the NHS, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
UK - Summary of NICE Appraisals in October 2009
NICE Rejects RoActemra for Rheumatoid Arthritis on the NHS
The National Institute for Health and Clinical Excellence (NICE) has issued preliminary guidance rejecting the use of RoActemra (tocilizumab) on the NHS to treat rheumatoid arthritis.
The drug, which is produced by Chugai Pharma and distributed by Roche, has demonstrated its potential benefits to patients in clinical trials. In studies including 4,000 patients, RoActemra, alone or in combination with a disease-modifying anti-rheumatic drug (DMARD), such as methotrexate, significantly reduced the symptoms of rheumatoid arthritis compared to DMARDs alone, regardless of previous therapies and the severity of the disease.
However, NICE has concluded that the drug is not cost-effective, costing £9,295 a year for a patient weighing around 70kg.
The National Rheumatoid Arthritis Society said the guidance means that sufferers’ only options now will be to retry therapies that have already failed or palliative care, which involves large doses of steroids which could cause side effects such as osteoporosis in the longer term.
NICE’s final guidance is due to be issued in February 2010.
NICE Approves Hycamtin for Small Cell Lung Cancer
NICE has approved Hycamtin (topotecan) for patients with small cell lung cancer on the NHS, under certain conditions.
The regulator’s Final Appraisal Determination recommends the use of the drug in patients suffering from a relapse of the disease, but only when treatment with the first-line therapy again is not appropriate, or the combination of cyclophosphamide, vincristine and doxorubicin chemotherapies is contraindicated.
In addition, the oral form of GlaxoSmithKline’s Hycamtin should be used, as the intravenous version is considered too expensive. The cost per cycle for the oral form of Hycamtin is £638, which is equal to an average cost per patient of £2,552, whereas the cost for the intravenous version is £1,495 and £5,980, respectively.
Lung cancer is one of the most common cancers in England, with over 33,000 new cases in England and Wales a year, of which between 10% and 20% are of the small cell type.
In September 2009, Hycamtin was approved by NICE to treat cervical cancer on the NHS (See NICE Approves NHS Use of Hycamtin for Cervical Cancer).
Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
The National Institute for Health and Clinical Excellence (NICE) has issued preliminary guidance rejecting the use of RoActemra (tocilizumab) on the NHS to treat rheumatoid arthritis.
The drug, which is produced by Chugai Pharma and distributed by Roche, has demonstrated its potential benefits to patients in clinical trials. In studies including 4,000 patients, RoActemra, alone or in combination with a disease-modifying anti-rheumatic drug (DMARD), such as methotrexate, significantly reduced the symptoms of rheumatoid arthritis compared to DMARDs alone, regardless of previous therapies and the severity of the disease.
However, NICE has concluded that the drug is not cost-effective, costing £9,295 a year for a patient weighing around 70kg.
The National Rheumatoid Arthritis Society said the guidance means that sufferers’ only options now will be to retry therapies that have already failed or palliative care, which involves large doses of steroids which could cause side effects such as osteoporosis in the longer term.
NICE’s final guidance is due to be issued in February 2010.
NICE Approves Hycamtin for Small Cell Lung Cancer
NICE has approved Hycamtin (topotecan) for patients with small cell lung cancer on the NHS, under certain conditions.
The regulator’s Final Appraisal Determination recommends the use of the drug in patients suffering from a relapse of the disease, but only when treatment with the first-line therapy again is not appropriate, or the combination of cyclophosphamide, vincristine and doxorubicin chemotherapies is contraindicated.
In addition, the oral form of GlaxoSmithKline’s Hycamtin should be used, as the intravenous version is considered too expensive. The cost per cycle for the oral form of Hycamtin is £638, which is equal to an average cost per patient of £2,552, whereas the cost for the intravenous version is £1,495 and £5,980, respectively.
Lung cancer is one of the most common cancers in England, with over 33,000 new cases in England and Wales a year, of which between 10% and 20% are of the small cell type.
In September 2009, Hycamtin was approved by NICE to treat cervical cancer on the NHS (See NICE Approves NHS Use of Hycamtin for Cervical Cancer).
Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
UK - Diabetes Now Affects 5% of the Population
Around one in twenty people in the UK has diabetes, with around 145,000 new cases diagnosed in the past year, according to figures published by Diabetes UK in October 2009.
The data was compiled from GP practices and reveals that 2.6 million people now suffer from the condition, and around 90% of these have diabetes type II, which is linked to obesity on many occasions.
Diabetes UK warned that the increasing number of cases is putting a strain on the NHS, as diabetes already costs the health service £1 million an hour to treat. Also, diabetes can lead to more serious conditions such as heart disease, stroke, kidney failure and blindness.
Furthermore, it is estimated that around half a million people in the UK have the condition but have not been diagnosed, as the condition can remain undetected for around 10 years. Therefore, many of these may already have complications by the time they are diagnosed.
The rise in cases of diabetes is known to be linked to rising levels of obesity, which is a factor in around 80% of cases of type II diabetes, according to the International Diabetes Federation.
Further reading - A detailed analysis of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
The data was compiled from GP practices and reveals that 2.6 million people now suffer from the condition, and around 90% of these have diabetes type II, which is linked to obesity on many occasions.
Diabetes UK warned that the increasing number of cases is putting a strain on the NHS, as diabetes already costs the health service £1 million an hour to treat. Also, diabetes can lead to more serious conditions such as heart disease, stroke, kidney failure and blindness.
Furthermore, it is estimated that around half a million people in the UK have the condition but have not been diagnosed, as the condition can remain undetected for around 10 years. Therefore, many of these may already have complications by the time they are diagnosed.
The rise in cases of diabetes is known to be linked to rising levels of obesity, which is a factor in around 80% of cases of type II diabetes, according to the International Diabetes Federation.
Further reading - A detailed analysis of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
Wednesday, 7 October 2009
Brazil - The government aims to create a ‘super’ local producer able to compete internationally, but foreign producers are a big threat
Pfizer … is it acquiring Neo Química?
Generics sales continue to grow at a higher rate than the overall pharmacy sector, and they are expected to represent 20% of the sector by volume in 2010. Therefore, the sector is attracting foreign interest. In September 2009, it was rumoured that the local generic producer Neo Química was being acquired by Pfizer. This would be the second major acquisition in the generic sector in 2009, following sanofi-aventis’ acquisition of Medley. This wave of foreign acquisitions is a blow for the government which has been trying to create a leading local pharmaceutical group with the help of the National Bank for Economic & Social Development (BNDES). Other leading producers such as EMS, Aché and Eurofarma remain local.
How are foreign producers assessing the market?
Leading foreign pharmaceutical companies are strengthening their operations in the country. Brazil is the most important BRIC market for sanofi-aventis; the company is acquiring Medley. Daiichi-Sankyo, the only Japanese company with manufacturing operations in Brazil, is expanding its plant. GlaxoSmithKline has announced an alliance with Fiocruz’s Bio-Manguinhos to develop vaccines. Novartis is setting up a vaccines plant. Pfizer is strengthening its operations via a rumoured local acquisition. In the wholesaling sector, Celesio, the largest European wholesaler, has acquired a majority state in the Panpharma group. Other companies are re-assessing their operations. Boehringer Ingelheim, for instance, has signed a third-party manufacturing agreement with Zambon, whilst Roche has announced plans to sell its manufacturing plant in Brazil.
How are local producers responding?
Local manufacturing investments continue in order to increase market positioning locally and internationally. Cristália, for instance, has inaugurated a new R&D centre; the company claims to be the local producer with the highest R&D portfolio and investments. EMS is investing in a new Drug Delivery Systems (DDS) platform. Eurofarma continues to invest in its animal health division in the local market, whiltst it has acquired an Argentine pharmaceutical producer in order to develop its international operations. Hipolabor is building a second manufacturing plant for the production of antibiotics. Even public producers follow the same trend. Fundação para o Remédio Popular (FURP), for example, has inaugurated a new manufacturing plant for the production of generic medicines, the first of its type.
Further reading - An in-depth analysis of the Brazilian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Brazil (published September 2009)
Generics sales continue to grow at a higher rate than the overall pharmacy sector, and they are expected to represent 20% of the sector by volume in 2010. Therefore, the sector is attracting foreign interest. In September 2009, it was rumoured that the local generic producer Neo Química was being acquired by Pfizer. This would be the second major acquisition in the generic sector in 2009, following sanofi-aventis’ acquisition of Medley. This wave of foreign acquisitions is a blow for the government which has been trying to create a leading local pharmaceutical group with the help of the National Bank for Economic & Social Development (BNDES). Other leading producers such as EMS, Aché and Eurofarma remain local.
How are foreign producers assessing the market?
Leading foreign pharmaceutical companies are strengthening their operations in the country. Brazil is the most important BRIC market for sanofi-aventis; the company is acquiring Medley. Daiichi-Sankyo, the only Japanese company with manufacturing operations in Brazil, is expanding its plant. GlaxoSmithKline has announced an alliance with Fiocruz’s Bio-Manguinhos to develop vaccines. Novartis is setting up a vaccines plant. Pfizer is strengthening its operations via a rumoured local acquisition. In the wholesaling sector, Celesio, the largest European wholesaler, has acquired a majority state in the Panpharma group. Other companies are re-assessing their operations. Boehringer Ingelheim, for instance, has signed a third-party manufacturing agreement with Zambon, whilst Roche has announced plans to sell its manufacturing plant in Brazil.
How are local producers responding?
Local manufacturing investments continue in order to increase market positioning locally and internationally. Cristália, for instance, has inaugurated a new R&D centre; the company claims to be the local producer with the highest R&D portfolio and investments. EMS is investing in a new Drug Delivery Systems (DDS) platform. Eurofarma continues to invest in its animal health division in the local market, whiltst it has acquired an Argentine pharmaceutical producer in order to develop its international operations. Hipolabor is building a second manufacturing plant for the production of antibiotics. Even public producers follow the same trend. Fundação para o Remédio Popular (FURP), for example, has inaugurated a new manufacturing plant for the production of generic medicines, the first of its type.
Further reading - An in-depth analysis of the Brazilian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Brazil (published September 2009)
Friday, 2 October 2009
South Africa - Government Pledges Quicker Access to New Medicines
The South African government pledged to clear the backlog of drug approvals and develop a recovery strategy for the pharmaceutical industry, in September 2009.
The Medicines Control Council (MCC) attributed the backlog to an unexpected increase in submissions for the registration of medicines during the last three years.
Since Mr Motsoaledi took over as Health Minister on 11th May 2009, he has voiced his commitment to healthcare reform, including making changes to the MCC to speed up access to new medicines and expand the availability of generic medicines.
The MCC is undertaking a 12 million rand (£990,000) backlog clearance project, with funding from the UK’s Department for International Development (DFID). The industry association, Innovative Medicines SA (IMSA), has welcomed the project as it said the current approval process can take up to four years and more than 2,000 applications are now stuck in the pipeline.
Further reading - A detailed analysis of the South African pharmaceutical market, including some background information on the drug approval process, is available from Espicom: The Pharmaceutical Market: South Africa (published June 2009)
The Medicines Control Council (MCC) attributed the backlog to an unexpected increase in submissions for the registration of medicines during the last three years.
Since Mr Motsoaledi took over as Health Minister on 11th May 2009, he has voiced his commitment to healthcare reform, including making changes to the MCC to speed up access to new medicines and expand the availability of generic medicines.
The MCC is undertaking a 12 million rand (£990,000) backlog clearance project, with funding from the UK’s Department for International Development (DFID). The industry association, Innovative Medicines SA (IMSA), has welcomed the project as it said the current approval process can take up to four years and more than 2,000 applications are now stuck in the pipeline.
Further reading - A detailed analysis of the South African pharmaceutical market, including some background information on the drug approval process, is available from Espicom: The Pharmaceutical Market: South Africa (published June 2009)
India - Doctors Working in Rural Areas to be Given More Money
Doctors who work in rural areas will be compensated with extra money and assistance when they apply for higher study, Health Minister Ghulam Nabi Azad announced on 17th September 2009.
The Indian government is also planning to set up more medical colleges, as there is expected to be a lack of medical personnel in the coming years. According to a Planning Commission report, India is facing a shortage of around 600,000 doctors, one million nurses and 200,000 dental surgeons.
Further reading - An in-depth review of the Indian pharmaceutical market, including some background information on healthcare personnel, is available from Espicom: The Pharmaceutical Market: India (published June 2009)
The Indian government is also planning to set up more medical colleges, as there is expected to be a lack of medical personnel in the coming years. According to a Planning Commission report, India is facing a shortage of around 600,000 doctors, one million nurses and 200,000 dental surgeons.
Further reading - An in-depth review of the Indian pharmaceutical market, including some background information on healthcare personnel, is available from Espicom: The Pharmaceutical Market: India (published June 2009)
Russia - Nycomed to Build Production Plant Near Moscow
In September 2009, Nycomed announced plans to build a production plant in Russia, with a total investment of between 65 million and 75 million euros (US$96 million and US$110 million).
The new site will be located in Yaroslavl, around 280 kilometres from Moscow, and construction will start there in 2010. The factory will have a total of 150 employees when production begins in 2014.
The new facility will manufacture medicines for the Russian and neighbouring markets of the Commonwealth of Independent States (CIS), which together account for 10% of Nycomed’s turnover.
Production taking place at the plant will include liquid sterile products such as ampoules and vials, as well as tablets. It will also manufacture products which are important for the local market, such as Cardiomagnyl (acetylsalicyclic acid and magnesium hydroxide) for pain relief, the bovine blood derivative Actovegin and the anticoagulant warfarin.
Further reading - An in-depth review of the Russian pharmaceutical market, including some background information on local manufacturers, is available from Espicom: The Pharmaceutical Market: Russia (published June 2009)
The new site will be located in Yaroslavl, around 280 kilometres from Moscow, and construction will start there in 2010. The factory will have a total of 150 employees when production begins in 2014.
The new facility will manufacture medicines for the Russian and neighbouring markets of the Commonwealth of Independent States (CIS), which together account for 10% of Nycomed’s turnover.
Production taking place at the plant will include liquid sterile products such as ampoules and vials, as well as tablets. It will also manufacture products which are important for the local market, such as Cardiomagnyl (acetylsalicyclic acid and magnesium hydroxide) for pain relief, the bovine blood derivative Actovegin and the anticoagulant warfarin.
Further reading - An in-depth review of the Russian pharmaceutical market, including some background information on local manufacturers, is available from Espicom: The Pharmaceutical Market: Russia (published June 2009)
UK - Renovo to Cut Jobs
UK-based Renovo is to cut the jobs of a third of its workforce as part of restructuring, the company revealed in September 2009.
The restructure comes after talks of a takeover with an unnamed company failed.
Renovo, which specialises in scar-reduction technology, hopes to reduce costs by around 20-30% by axing around 50 of its 160 employees.
In addition to job cuts, the company will freeze directors’ salaries in order to retain cash for the Phase III trials of Juvista.
Further reading - A detailed review of the UK pharmaceutical market, including some more information on domestic producers, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The restructure comes after talks of a takeover with an unnamed company failed.
Renovo, which specialises in scar-reduction technology, hopes to reduce costs by around 20-30% by axing around 50 of its 160 employees.
In addition to job cuts, the company will freeze directors’ salaries in order to retain cash for the Phase III trials of Juvista.
Further reading - A detailed review of the UK pharmaceutical market, including some more information on domestic producers, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Pharmacies to Receive Increased Funding
Pharmacy funding is to increase by 3.9% in 2010, following negotiations between the Department of Health and the Pharmaceutical Services Negotiating Committee (PSNC) in September 2009.
The extra £87 million will bring total funding for primary care pharmaceuticals services to £2.3 billion.
The government has also agreed to make additional provisions to help pharmacy contractors cope with one-off costs, such as the implementation of the second stage of an electronic prescription service.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The extra £87 million will bring total funding for primary care pharmaceuticals services to £2.3 billion.
The government has also agreed to make additional provisions to help pharmacy contractors cope with one-off costs, such as the implementation of the second stage of an electronic prescription service.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Thursday, 17 September 2009
USA - Eli Lilly to Cut 5,500 Jobs by 2011
Eli Lilly is cutting 5,500 jobs by the end of 2011 as part of restructuring, it was announced in September 2009.
The company, based in Indiana, expects the plans to cut annual costs by US$1 billion.
The reorganisation will split the company into five business areas: oncology, diabetes, established markets, emerging markets and animal health. Lilly also plans to establish a Development Centre of Excellence, which will focus on the development of new medicines.
Although Lilly is yet to confirm where the job losses will take place, they will exclude strategic sales additions in emerging markets and Japan.
The company attributed the restructure to upcoming challenges for the company, including patent expiries, increased generic competition, rising costs and slowing innovation.
Lilly is currently preparing for the patent expiry of its top-selling antipsychotic drug Zyprexa (olanzapine), while generic competition has reduced sales of its chemotherapy Gemza (gemcitabine) since it went off-patent.
Further reading - A detailed analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
The company, based in Indiana, expects the plans to cut annual costs by US$1 billion.
The reorganisation will split the company into five business areas: oncology, diabetes, established markets, emerging markets and animal health. Lilly also plans to establish a Development Centre of Excellence, which will focus on the development of new medicines.
Although Lilly is yet to confirm where the job losses will take place, they will exclude strategic sales additions in emerging markets and Japan.
The company attributed the restructure to upcoming challenges for the company, including patent expiries, increased generic competition, rising costs and slowing innovation.
Lilly is currently preparing for the patent expiry of its top-selling antipsychotic drug Zyprexa (olanzapine), while generic competition has reduced sales of its chemotherapy Gemza (gemcitabine) since it went off-patent.
Further reading - A detailed analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
Ireland - Teva to Cut 315 Jobs in Waterford
Teva is cutting 315 jobs at its plant in Waterford, Ireland, it was announced in September 2009.
The plant, which currently has 730 employees, manufactures tablets and inhalers, but following the job losses the production of tablets will be relocated to a factory in Hungary. It is expected that tablet production at the site will cease within 12 months.
Further reading - An in-depth analysis of the Irish pharmaceutical market is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
The plant, which currently has 730 employees, manufactures tablets and inhalers, but following the job losses the production of tablets will be relocated to a factory in Hungary. It is expected that tablet production at the site will cease within 12 months.
Further reading - An in-depth analysis of the Irish pharmaceutical market is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
Hungary - N-Gene Hungary and Mecsek Pharma Receive HUF 1 billion in Funding
N-Gene Hungary and Mecsek Pharma have been approved for HUF 1 billion (US$4.7 million) funding from the Economic Development Program budget, it was announced in August 2009.
N-Gene, a biotech firm, and Mecsek Pharma, an R&D business, are about to start clinical trials of a new diabetes drug, a formula which is the sole intellectual property of N-Gene.
Further reading - A detailed analysis of the Hungarian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Hungary (published June 2009)
N-Gene, a biotech firm, and Mecsek Pharma, an R&D business, are about to start clinical trials of a new diabetes drug, a formula which is the sole intellectual property of N-Gene.
Further reading - A detailed analysis of the Hungarian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Hungary (published June 2009)
UK - Analysis Reveals Uptake of Pharmaceuticals Following NICE Approval
A new report, Use of NICE-appraised Medicines in the NHS in England – Experimental Statistics, published by the NHS Information Centre in September 2009, has looked at the uptake of pharmaceuticals appraised by the National Institute for Health and Clinical Excellence (NICE).
The review studied 26 drugs positively appraised by NICE, covering 13 technology appraisals.
The report indicates that out of 12 appraisals where a comparison could be established, use on the NHS in 2008 was higher than expected for seven appraisals and lower for five appraisals.
The appraisals where observed use exceeded the predicted use in 2008 are:
The Association of the British Pharmaceutical Industry (ABPI), however, has questioned the basis on which the predictions were made as it appears to be too low. The ABPI also believes that the statistics on the use of such medicines in England should be set against a comparison of uptake in other, comparable European countries.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on NICE appraisals, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The review studied 26 drugs positively appraised by NICE, covering 13 technology appraisals.
The report indicates that out of 12 appraisals where a comparison could be established, use on the NHS in 2008 was higher than expected for seven appraisals and lower for five appraisals.
The appraisals where observed use exceeded the predicted use in 2008 are:
- Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease;
- Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia;
- Entecavir for the treatment of chronic hepatitis B;
- Zaleplon, zolpidem and zopiclone for the short-term management of insomnia;
- Varenicline for smoking cessation;
- Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer; and
- Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women, plus alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.
- Omalizumab for severe persistent allergic asthma;
- Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis;
- Drotrecogin alfa (activated) for severe sepsis;
- Riluzole (Rilutek) for the treatment of motor neuron disease; and
- Orlistat, sibutramine and rimonabant for the treatment of obesity in adults.
The Association of the British Pharmaceutical Industry (ABPI), however, has questioned the basis on which the predictions were made as it appears to be too low. The ABPI also believes that the statistics on the use of such medicines in England should be set against a comparison of uptake in other, comparable European countries.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on NICE appraisals, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Summary of NICE Approvals in September 2009
NICE Provisionally Approves Drugs for Crohn’s Disease
The National Institute for Health and Clinical Excellence (NICE) has recommended the use of Humira (adalimumab) and Remicade (infliximab) on the NHS for the treatment of Crohn’s disease, on a preliminary basis.
Abbott Laboratories’ Humira has preliminary approval as an option for induction and maintenance therapy in adults with severe active non-fistulising Crohn’s disease. Schering Plough/ Johnson & Johnson’s Remicade has also been approved but only if the patient is intolerant of Humira, if the patient is a child or if the Crohn’s disease is fistulising.
Humira has been given preference over Remicade purely for cost reasons. They are considered to be as effective as each other, with Humira costing £9,295 a year while Remicade costs £12,584 a year, and so Humira is judged to be more cost effective.
There is no cure for Crohn’s disease, which affects around 60,000 people in the UK, and so treatment strategies focus on reducing the symptoms of the illness and extending periods of remission.
NICE Approves NHS Use of Hycamtin for Cervical Cancer
NICE has issued a final appraisal recommending the use of GlaxoSmithKline’s Hycamtin (topotecan) on the NHS to treat recurrent cervical cancer.
Initially, NICE expressed “considerable uncertainty” over the effectiveness of the drug compared to other available treatments, when taking into account potential side effects, and so it was thought it would be rejected.
However, following a second appraisal committee and additional data submitted by GSK, NICE now recommends the use of Hycamtin, in combination with the chemotherapy cisplatin, to treat recurrent or stage IVB cervical cancer.
However, it is under the condition that the patient must not have received previous therapy with cisplatin, and so only a small number of patients will be eligible, since around 90-95% of the current licensed population for Hycamtin will have already received some form of therapy with cisplatin. This condition is important, however, as response rates in patients who have not been treated with cisplatin are about 45%, compared to just 10% for those who have been exposed to the drug.
NICE Approves Blood-Thinner Efient Under Certain Conditions
NICE has published a final appraisal approving the blood-thinner Efient (prasugrel) for use on the NHS, but only for a select group of patients.
Specifically, NICE has approved Eli Lilly/Daiichi Sankyo’s Efient in combination with aspirin as an option for preventing atherothrombotic events in patients with acute coronary syndromes having percutaneous coronary intervention. However, the drug should only be used in limited cases, firstly when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary. Efient can also be used when stent thrombosis has occurred during treatment with sanofi-aventis and Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel) or if the patient has diabetes mellitus.
NICE Rejects Nexavar for the Treatment of Liver Cancer on the NHS
NICE has rejected Nexavar (sorafenib) for the treatment of liver cancer on the NHS.
The decision comes despite Bayer’s offer to lower the cost of the drug, which has also been turned down for the treatment of kidney cancer on the NHS. Nexavar treats advanced hepatocellular carcinoma (HCC), which accounts for around 90% of all liver tumours.
Janssen-Cilag’s Stelara Approved for Treatment of Psoriasis on the NHS
Stelara (ustekinumab) has been approved for use on the NHS by NICE as a treatment for moderate to severe plaque psoriasis.
Janssen-Cilag’s Stelara is a new, fully human monoclonal antibody which works by targeting the p40 subunit of the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). The drug also has a convenient dosing regimen with just five injections per year, compared to a possible 104 injections with alternative treatment etanercept.
The drug was considered a cost-effective use of NHS resources but only under a patient access scheme proposed by Janssen Cilag, whereby it provides the 90mg dose necessary for patients weighing more than 100kg at the same cost as a single 45 mg vial, to keep the cost of treatment at £9,335 a year.
Eli Lilly’s Alimta Approved for NHS Use
NICE has approved Eli Lilly’s Alimta (pemetrexed) for use on the NHS, as a first-line treatment for patients with non-small cell lung cancer (NSCLC) in combination with the chemotherapy cisplatin. However, it has only been recommended if the disease has spread, or if the tumour is classed as an adenocarcinoma or large-cell carcinoma.
Every year around 38,000 people are diagnosed with NSCLC in the UK, of which 45% are adenocarcinoma and 10% large cell carcinoma.
Pfizer’s Sutent Recommended for Use on the NHS for GISTs
NICE has published final guidance recommending the use of Sutent (sunitinib) on the NHS in patients who have unresectable or metastatic gastro-intestinal stromal tumours (GIST) and are intolerant or unresponsive to therapy with Novartis’ Glivec (imatinib).
The guidance is subject to a patient access scheme, whereby the manufacturer Pfizer pays for the first cycle of treatment with the drug.
Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The National Institute for Health and Clinical Excellence (NICE) has recommended the use of Humira (adalimumab) and Remicade (infliximab) on the NHS for the treatment of Crohn’s disease, on a preliminary basis.
Abbott Laboratories’ Humira has preliminary approval as an option for induction and maintenance therapy in adults with severe active non-fistulising Crohn’s disease. Schering Plough/ Johnson & Johnson’s Remicade has also been approved but only if the patient is intolerant of Humira, if the patient is a child or if the Crohn’s disease is fistulising.
Humira has been given preference over Remicade purely for cost reasons. They are considered to be as effective as each other, with Humira costing £9,295 a year while Remicade costs £12,584 a year, and so Humira is judged to be more cost effective.
There is no cure for Crohn’s disease, which affects around 60,000 people in the UK, and so treatment strategies focus on reducing the symptoms of the illness and extending periods of remission.
NICE Approves NHS Use of Hycamtin for Cervical Cancer
NICE has issued a final appraisal recommending the use of GlaxoSmithKline’s Hycamtin (topotecan) on the NHS to treat recurrent cervical cancer.
Initially, NICE expressed “considerable uncertainty” over the effectiveness of the drug compared to other available treatments, when taking into account potential side effects, and so it was thought it would be rejected.
However, following a second appraisal committee and additional data submitted by GSK, NICE now recommends the use of Hycamtin, in combination with the chemotherapy cisplatin, to treat recurrent or stage IVB cervical cancer.
However, it is under the condition that the patient must not have received previous therapy with cisplatin, and so only a small number of patients will be eligible, since around 90-95% of the current licensed population for Hycamtin will have already received some form of therapy with cisplatin. This condition is important, however, as response rates in patients who have not been treated with cisplatin are about 45%, compared to just 10% for those who have been exposed to the drug.
NICE Approves Blood-Thinner Efient Under Certain Conditions
NICE has published a final appraisal approving the blood-thinner Efient (prasugrel) for use on the NHS, but only for a select group of patients.
Specifically, NICE has approved Eli Lilly/Daiichi Sankyo’s Efient in combination with aspirin as an option for preventing atherothrombotic events in patients with acute coronary syndromes having percutaneous coronary intervention. However, the drug should only be used in limited cases, firstly when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary. Efient can also be used when stent thrombosis has occurred during treatment with sanofi-aventis and Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel) or if the patient has diabetes mellitus.
NICE Rejects Nexavar for the Treatment of Liver Cancer on the NHS
NICE has rejected Nexavar (sorafenib) for the treatment of liver cancer on the NHS.
The decision comes despite Bayer’s offer to lower the cost of the drug, which has also been turned down for the treatment of kidney cancer on the NHS. Nexavar treats advanced hepatocellular carcinoma (HCC), which accounts for around 90% of all liver tumours.
Janssen-Cilag’s Stelara Approved for Treatment of Psoriasis on the NHS
Stelara (ustekinumab) has been approved for use on the NHS by NICE as a treatment for moderate to severe plaque psoriasis.
Janssen-Cilag’s Stelara is a new, fully human monoclonal antibody which works by targeting the p40 subunit of the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). The drug also has a convenient dosing regimen with just five injections per year, compared to a possible 104 injections with alternative treatment etanercept.
The drug was considered a cost-effective use of NHS resources but only under a patient access scheme proposed by Janssen Cilag, whereby it provides the 90mg dose necessary for patients weighing more than 100kg at the same cost as a single 45 mg vial, to keep the cost of treatment at £9,335 a year.
Eli Lilly’s Alimta Approved for NHS Use
NICE has approved Eli Lilly’s Alimta (pemetrexed) for use on the NHS, as a first-line treatment for patients with non-small cell lung cancer (NSCLC) in combination with the chemotherapy cisplatin. However, it has only been recommended if the disease has spread, or if the tumour is classed as an adenocarcinoma or large-cell carcinoma.
Every year around 38,000 people are diagnosed with NSCLC in the UK, of which 45% are adenocarcinoma and 10% large cell carcinoma.
Pfizer’s Sutent Recommended for Use on the NHS for GISTs
NICE has published final guidance recommending the use of Sutent (sunitinib) on the NHS in patients who have unresectable or metastatic gastro-intestinal stromal tumours (GIST) and are intolerant or unresponsive to therapy with Novartis’ Glivec (imatinib).
The guidance is subject to a patient access scheme, whereby the manufacturer Pfizer pays for the first cycle of treatment with the drug.
Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NHS Report Reveals Concerns on Treatment Available for Blood Cancer Patients
A survey, published in September 2009, has revealed that 18% of patients suffering from myelodysplastic syndromes (MDS), a type of blood cancer, could have lived longer if drugs were available to them, which are currently not approved by the National Institute for Health and Clinical Excellence (NICE) for use on the NHS.
The survey, conducted by the UK MDS Patient Support Group, also found that 56 of 100 haematologists believe lower priority is given to rarer cancers than other types of cancer.
Of those surveyed, 89% said they had faced situations in which they have been unable to provide treatments for a patient because the drug they needed is not available on the NHS or has not been approved by NICE. Furthermore, around 12% of respondents said they had not informed patients of treatments which could be beneficial to them, at the risk of distressing them over treatments they cannot have.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE appraisals, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The survey, conducted by the UK MDS Patient Support Group, also found that 56 of 100 haematologists believe lower priority is given to rarer cancers than other types of cancer.
Of those surveyed, 89% said they had faced situations in which they have been unable to provide treatments for a patient because the drug they needed is not available on the NHS or has not been approved by NICE. Furthermore, around 12% of respondents said they had not informed patients of treatments which could be beneficial to them, at the risk of distressing them over treatments they cannot have.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE appraisals, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NHS Workforce Proposals Rejected
Proposals to cut the NHS workforce in England by up to 10% in the next five years have been rejected by the government, who claim the NHS need more staff, not less.
Consultancy firm McKinsey and Company advised the Department of Health in September 2009 that the loss of 137,000 clinical and administration posts would save around £20 billion by 2014. The report also recommended a recruitment freeze to begin within two years, with the possibility of medical school places being reduced, and also suggested an early retirement programme should be established.
However, Health Minister Mike O’Brien said, “Ministers have rejected the suggested proposals in the McKinsey report and there are no plans to adopt these proposals in the future”, claiming that certain services, particularly maternity, nursing and primary care, need more staff rather than fewer.
McKinsey also claimed that up to £3 billion a year could be saved by improving staff productivity, while nearly £2 billion could be saved on external contracts for areas such as food and waste.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on healthcare personnel, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Consultancy firm McKinsey and Company advised the Department of Health in September 2009 that the loss of 137,000 clinical and administration posts would save around £20 billion by 2014. The report also recommended a recruitment freeze to begin within two years, with the possibility of medical school places being reduced, and also suggested an early retirement programme should be established.
However, Health Minister Mike O’Brien said, “Ministers have rejected the suggested proposals in the McKinsey report and there are no plans to adopt these proposals in the future”, claiming that certain services, particularly maternity, nursing and primary care, need more staff rather than fewer.
McKinsey also claimed that up to £3 billion a year could be saved by improving staff productivity, while nearly £2 billion could be saved on external contracts for areas such as food and waste.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on healthcare personnel, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - GP Consultations Rising
The number of GP consultations has risen from 217.3 million in 1995 to 300.4 million in 2008, according to data published by the NHS Information Centre in September 2009.
The study, conducted using the QResearch general practice database, revealed that an average patient had 5.5 consultations in 2008, compared with 3.9 in 1995. Meanwhile, the average GP surgery carried out 34,200 appointments in 2008, up from 21,100 in 1995.
The study also highlighted an increase in the number of patients seen by a nurse in primary care. In 1995, 76% of consultations were undertaken by GPs, 21% by nurses and 3% by other clinicians, whereas in 2008, 62% were carried out by GPs, 34% by nurses and 4% by other clinicians. However, this increase in proportion could be explained by an increase in patients seeing nurses in general, rather than fewer patients seeing a GP.
However, the study did not take into account the length of consultations, or the number of tasks undertaken within a consultation, which could impact on the reliability of the findings.
Further reading - A detailed analysis of the UK pharmaceutical market, including further statistics on ambulatory care, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The study, conducted using the QResearch general practice database, revealed that an average patient had 5.5 consultations in 2008, compared with 3.9 in 1995. Meanwhile, the average GP surgery carried out 34,200 appointments in 2008, up from 21,100 in 1995.
The study also highlighted an increase in the number of patients seen by a nurse in primary care. In 1995, 76% of consultations were undertaken by GPs, 21% by nurses and 3% by other clinicians, whereas in 2008, 62% were carried out by GPs, 34% by nurses and 4% by other clinicians. However, this increase in proportion could be explained by an increase in patients seeing nurses in general, rather than fewer patients seeing a GP.
However, the study did not take into account the length of consultations, or the number of tasks undertaken within a consultation, which could impact on the reliability of the findings.
Further reading - A detailed analysis of the UK pharmaceutical market, including further statistics on ambulatory care, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
China - Essential Medicines List Published as Part of Health Reforms
The Chinese government has released a list of essential medicines, which will be sold at controlled prices from September 2009, as part of reforms to make healthcare more affordable.
The 307 drugs on the list account for around 25% of national drug spending, and are used to treat around 80% of the most common diseases in China.
The list has been put together as part of the country’s 850 billion yuan (US$124.5 billion) health service reform, which is aiming to provide basic healthcare cover for at least 90% of the population by 2011.
The price-controlled medicines will be sold at 30% of the community medical facilities, and by 2020 they will be the first-choice medicines at all state-run health institutions. The government will regulate the cost of the drugs and they will be purchased by provincial governments through procurement auctions. Guideline prices will be published every year, and the list will be updated every three years according to changes in demand.
The drugs on the list, which include both Western and traditional Chinese medicines, will be eligible for state subsidies of up to 100%, making them more affordable for the population of 1.3 billion.
China’s Health Ministry said the list would create competition among manufacturers to get drugs approved, and could lead to more mergers and acquisitions in the pharmaceutical industry.
Further reading - For more information see related article: China - Essential Medicines System May Lead to Market Expansion. An in-depth analysis of the Chinese pharmaceutical market, including some background information on healthcare reforms, is available from Espicom: The Pharmaceutical Market: China (published July 2009)
The 307 drugs on the list account for around 25% of national drug spending, and are used to treat around 80% of the most common diseases in China.
The list has been put together as part of the country’s 850 billion yuan (US$124.5 billion) health service reform, which is aiming to provide basic healthcare cover for at least 90% of the population by 2011.
The price-controlled medicines will be sold at 30% of the community medical facilities, and by 2020 they will be the first-choice medicines at all state-run health institutions. The government will regulate the cost of the drugs and they will be purchased by provincial governments through procurement auctions. Guideline prices will be published every year, and the list will be updated every three years according to changes in demand.
The drugs on the list, which include both Western and traditional Chinese medicines, will be eligible for state subsidies of up to 100%, making them more affordable for the population of 1.3 billion.
China’s Health Ministry said the list would create competition among manufacturers to get drugs approved, and could lead to more mergers and acquisitions in the pharmaceutical industry.
Further reading - For more information see related article: China - Essential Medicines System May Lead to Market Expansion. An in-depth analysis of the Chinese pharmaceutical market, including some background information on healthcare reforms, is available from Espicom: The Pharmaceutical Market: China (published July 2009)
USA and France - sanofi-aventis to Close US Manufacturing Plant
French company sanofi-aventis is to close its manufacturing plant in Kansas City, USA, after failing to find a suitable buyer for the site, it was announced in August 2009.
The 33 year-old plant, which sanofi-aventis has owned since 2000, manufactures solid-dose oral medications including Allegra.
The operations will slowly be shut down before being closed altogether by mid-2012.
Further reading - Detailed reviews of the pharmaceutical markets in the USA and France are available from Espicom: The Pharmaceutical Market: USA (published June 2009) and The Pharmaceutical Market: France (published June 2009)
The 33 year-old plant, which sanofi-aventis has owned since 2000, manufactures solid-dose oral medications including Allegra.
The operations will slowly be shut down before being closed altogether by mid-2012.
Further reading - Detailed reviews of the pharmaceutical markets in the USA and France are available from Espicom: The Pharmaceutical Market: USA (published June 2009) and The Pharmaceutical Market: France (published June 2009)
USA and UK - Warner Chilcott to Acquire Procter & Gamble’s Drug Unit
Warner Chilcott is to acquire Procter & Gamble’s prescription drug business in a deal worth US$3.1 billion, it was announced in August 2009.
Warner Chilcott is a specialist in women’s health, and the deal will expand its focus to musculoskeletal disorders and gastrointestinal problems too.
Procter & Gamble’s portfolio of branded drugs includes Asacol (mesalamine) for ulcerative colitis, and Actonel (risedronate), an osteoporosis drug. Warner Chilcott will also acquire Procter & Gamble’s drug pipeline.
Warner Chilcott will take over manufacturing sites in Puerto Rico and Germany, which will add to its existing sites also in Puerto Rico and in Northern Ireland. It is expected that the 2,300 Procter & Gamble employees will be transferred to the new owner.
The transaction should be completed by the end of 2009.
Further reading - In-depth reviews of the pharmaceutical markets in the USA and the UK are available from Espicom: The Pharmaceutical Market: USA (published June 2009) and The Pharmaceutical Market: United Kingdom (published June 2009)
Warner Chilcott is a specialist in women’s health, and the deal will expand its focus to musculoskeletal disorders and gastrointestinal problems too.
Procter & Gamble’s portfolio of branded drugs includes Asacol (mesalamine) for ulcerative colitis, and Actonel (risedronate), an osteoporosis drug. Warner Chilcott will also acquire Procter & Gamble’s drug pipeline.
Warner Chilcott will take over manufacturing sites in Puerto Rico and Germany, which will add to its existing sites also in Puerto Rico and in Northern Ireland. It is expected that the 2,300 Procter & Gamble employees will be transferred to the new owner.
The transaction should be completed by the end of 2009.
Further reading - In-depth reviews of the pharmaceutical markets in the USA and the UK are available from Espicom: The Pharmaceutical Market: USA (published June 2009) and The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Increase in Parallel Exports Leads to Drug Shortages
There are medicine shortages in pharmacies across the UK, due to a sharp increase in parallel exports, as a result of current exchange rates.
In a survey of 150 community pharmacies, compiled by Chemist and Druggist in August 2009, nearly a third of respondents claimed patients had suffered because of delays in accessing medicines, while 89% said they were “very concerned” and 11% had “some concern” that patients would be affected.
The Association of the British Pharmaceutical Industry (ABPI) said that three pharmaceutical companies had been forced to arrange 77,020 shipments for the UK in January to May this year because of supply shortages, whereas in the same period in 2008 this amounted to just 6,134 cases.
Historically, drug prices in the UK have been comparatively high, and the country was often a destination for parallel imports from countries with lower prices, such as Greece and Spain. However, the weakening British pound against the euro has meant that prices of medicines have fallen and are now being exported to other EU countries.
The ABPI has put together a ‘watch list’ of 24 prescription drugs which pharmacies are having difficulties obtaining. However, manufacturers of these drugs have said that they provided more than enough to treat patients across the UK. For example, Novartis provided 65% more of Myfortic, a drug which prevents rejection in kidney transplant patients, than was required for patients in the UK, suggesting that much of it is being diverted for sale abroad.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on parallel importing and exporting in the country, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
In a survey of 150 community pharmacies, compiled by Chemist and Druggist in August 2009, nearly a third of respondents claimed patients had suffered because of delays in accessing medicines, while 89% said they were “very concerned” and 11% had “some concern” that patients would be affected.
The Association of the British Pharmaceutical Industry (ABPI) said that three pharmaceutical companies had been forced to arrange 77,020 shipments for the UK in January to May this year because of supply shortages, whereas in the same period in 2008 this amounted to just 6,134 cases.
Historically, drug prices in the UK have been comparatively high, and the country was often a destination for parallel imports from countries with lower prices, such as Greece and Spain. However, the weakening British pound against the euro has meant that prices of medicines have fallen and are now being exported to other EU countries.
The ABPI has put together a ‘watch list’ of 24 prescription drugs which pharmacies are having difficulties obtaining. However, manufacturers of these drugs have said that they provided more than enough to treat patients across the UK. For example, Novartis provided 65% more of Myfortic, a drug which prevents rejection in kidney transplant patients, than was required for patients in the UK, suggesting that much of it is being diverted for sale abroad.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on parallel importing and exporting in the country, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NICE Rejects Appeal Over Kidney Cancer Drugs
The National Institute for Health and Clinical Excellence (NICE) has rejected an appeal to make Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) available on the NHS for patients with renal cancer.
NICE issued guidance on 26th August 2009, which does not recommend Roche’s Avastin, Bayer’s Nexavar and Wyeth’s Torisel as a first-line treatment for advanced and/or metastatic renal cell carcinoma. NICE has also refused approval on the NHS for the use of Nexavar and Sutent (sunitinib) as secondary treatment options.
In August 2008, all four drugs were rejected as first-line treatments, but NICE changed its mind about Pfizer’s Sutent in March 2009, approving it for NHS use. However, NICE still rejected the other three drugs because they were not considered to be a cost effective use of NHS resources. An appeal was lodged against the Final Appraisal Determination by Roche, Wyeth, the James Whale Fund for Kidney Cancer and a joint appeal from Rarer Cancer Forum and Macmillan Cancer Support, but these have not been upheld.
NICE said Avastin costs £,5,982 per patient for the first six-week cycle and £6,117 for subsequent six-week cycles (around £53,000 per patient per year). Nexavar is £2,980.47 for 112 tablets while Torisel costs £620 per vial.
The guidance will be considered for review in June 2011.
Further reading - An in-depth review of the UK pharmaceutical market, including more information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
NICE issued guidance on 26th August 2009, which does not recommend Roche’s Avastin, Bayer’s Nexavar and Wyeth’s Torisel as a first-line treatment for advanced and/or metastatic renal cell carcinoma. NICE has also refused approval on the NHS for the use of Nexavar and Sutent (sunitinib) as secondary treatment options.
In August 2008, all four drugs were rejected as first-line treatments, but NICE changed its mind about Pfizer’s Sutent in March 2009, approving it for NHS use. However, NICE still rejected the other three drugs because they were not considered to be a cost effective use of NHS resources. An appeal was lodged against the Final Appraisal Determination by Roche, Wyeth, the James Whale Fund for Kidney Cancer and a joint appeal from Rarer Cancer Forum and Macmillan Cancer Support, but these have not been upheld.
NICE said Avastin costs £,5,982 per patient for the first six-week cycle and £6,117 for subsequent six-week cycles (around £53,000 per patient per year). Nexavar is £2,980.47 for 112 tablets while Torisel costs £620 per vial.
The guidance will be considered for review in June 2011.
Further reading - An in-depth review of the UK pharmaceutical market, including more information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NICE Approves Erbitux for NHS Use
The National Institute for Health and Clinical Excellence (NICE) issued final guidance in August 2009 recommending the use of Erbitux (cetuximab) on the NHS to treat bowel cancer.
More specifically, Merck KGaA’s Erbitux has been approved for use in combination with the chemotherapy FOLFOX (5-fluorouracil, folinic acid and oxaliplatin) as a first-line treatment for patients with colorectal cancer. However this is subject to the following conditions: the tumour in the bowel must be operable; the cancer must only have spread to the liver and is inoperable; and the patient must be well enough for surgery on both tumours if this is possible after the treatment has taken effect.
NICE has also approved the use of Erbitux in combination with FOLFIRI (5-FU, folinic acid and irinotecan) as a first-line treatment if the patient is unable to take oxaliplatin.
The drug is subject to a cost-sharing agreement proposed by Merck, whereby it offers a 16% rebate to the NHS on the cost of treatment per patient. NICE has also stipulated that no one should be treated with the drug for more than 16 weeks.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
More specifically, Merck KGaA’s Erbitux has been approved for use in combination with the chemotherapy FOLFOX (5-fluorouracil, folinic acid and oxaliplatin) as a first-line treatment for patients with colorectal cancer. However this is subject to the following conditions: the tumour in the bowel must be operable; the cancer must only have spread to the liver and is inoperable; and the patient must be well enough for surgery on both tumours if this is possible after the treatment has taken effect.
NICE has also approved the use of Erbitux in combination with FOLFIRI (5-FU, folinic acid and irinotecan) as a first-line treatment if the patient is unable to take oxaliplatin.
The drug is subject to a cost-sharing agreement proposed by Merck, whereby it offers a 16% rebate to the NHS on the cost of treatment per patient. NICE has also stipulated that no one should be treated with the drug for more than 16 weeks.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Wednesday, 2 September 2009
USA - Taking Medicines Incorrectly Costs US$290 billion a Year
Many patients in the USA do not take their medications as prescribed, resulting in costs of US$290 billion a year, according to a report by the New England Healthcare Institute (NEHI) published in August 2009.
It is estimated that between one third and a half of patients incorrectly take their medications, and the costs incurred amount to 13% of the total health expenditure.
The report, Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease, also found that it is patients with chronic illnesses, such as diabetes or high blood pressure, who are less likely to take their medications as intended, than those being treated for an urgent problem.
The study attributes the mistakes to high costs, unpleasant side effects, confusing regimes, forgetfulness and other patient behaviours, such as feeling too good to need medication. It outlines four solutions which could reduce the problem:
It is estimated that between one third and a half of patients incorrectly take their medications, and the costs incurred amount to 13% of the total health expenditure.
The report, Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease, also found that it is patients with chronic illnesses, such as diabetes or high blood pressure, who are less likely to take their medications as intended, than those being treated for an urgent problem.
The study attributes the mistakes to high costs, unpleasant side effects, confusing regimes, forgetfulness and other patient behaviours, such as feeling too good to need medication. It outlines four solutions which could reduce the problem:
- Creating healthcare teams - incorporating nurses, pharmacists and other clinicians in supporting medication adherence;
- Patient engagement and education - involving primary care providers and pharmacists to ensure patients know the importance of taking their medication properly;
- Payment reform - changing reimbursement incentives away from rewarding volume and towards rewarding good patient outcomes, which would encourage providers to invest in resources, such as counselling services, to improve medication adherence; and
- Leveraging health information technologies - using technology such as e-health records and e-prescribing, to give providers secure knowledge of the patient’s current medications and when prescriptions are due to be refilled.
Further reading - A detailed analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
Canada - Government Delays Result in Poor Access to New Medicines
After waiting considerable lengths of time for the Canadian government to approve new drugs, patients often then discover that their provincial drug plans will not pay for them, a report published in August 2009 has found.
The study, Access Delayed, Access Denied: Waiting for New Medicines in Canada, by the Fraser Institute, found that the regulatory agency, Health Canada, takes around 14 months to approve new drugs as safe and effective. Although private insurers will then cover these medicines immediately, it can take the provincial governments up to a year to decide whether they will cover them. The findings of the study then state that, in many cases, the drugs are then not given coverage at all.
The report found that Health Canada took an average of 453 days to approve new drugs in 2007, and the provinces then took a further 314 days to approve them under their drug plans. However, this is a marked improvement from 2004, when Health Canada took an average of 839 days and the provinces took around 552 days to approve new medicines, totalling 1,391 days or almost four years.
Furthermore, only 10.1% of new drugs approved by Health Canada in 2007 were being fully or partially reimbursed under provincial drug plans by the end of 2008.
The report proposed three policy changes which could speed up the approval process to ensure Canadians have access to new medicines:
The study, Access Delayed, Access Denied: Waiting for New Medicines in Canada, by the Fraser Institute, found that the regulatory agency, Health Canada, takes around 14 months to approve new drugs as safe and effective. Although private insurers will then cover these medicines immediately, it can take the provincial governments up to a year to decide whether they will cover them. The findings of the study then state that, in many cases, the drugs are then not given coverage at all.
The report found that Health Canada took an average of 453 days to approve new drugs in 2007, and the provinces then took a further 314 days to approve them under their drug plans. However, this is a marked improvement from 2004, when Health Canada took an average of 839 days and the provinces took around 552 days to approve new medicines, totalling 1,391 days or almost four years.
Furthermore, only 10.1% of new drugs approved by Health Canada in 2007 were being fully or partially reimbursed under provincial drug plans by the end of 2008.
The report proposed three policy changes which could speed up the approval process to ensure Canadians have access to new medicines:
- Regulatory co-operation with other countries - Canada should enter into mutual recognition agreements with other countries, introducing new medicines onto the Canadian market far more rapidly.
- Performance-based user fees - the government should establish, and strictly enforce, targets that Health Canada must meet before it receives user fees from drug companies, as is the case in the US.
- Replace government drug programmes with subsidized access to private insurance - introduce means-tested, publicly standardized access to private insurance for prescription drugs, to ensure that everyone has adequate drug insurance coverage, without delaying access to new medicines.
Further reading - An in-depth analysis of the Canadian pharmaceutical market, including some background information on drug approval processes, is available from Espicom: The Pharmaceutical Market: Canada (published June 2009)
Ireland - Pharmacy Strike Comes to an End (UPDATE)
The Irish pharmacy strike came to an end on 11th August 2009, after the Irish Pharmacy Union (IPU) released a statement urging pharmacies to resume services over fears for patient safety.
The Executive of the IPU said the industrial action had to end to prevent the recurrence of “chaotic scenes” which have occurred since many pharmacies withdrew their services on 1st August 2009 (See Ireland - Pay Cut Leads to Pharmaceutical Supply Crisis and Ireland - Pharmacy Row Taken to High Court).
The Minister for Health and Children, Mary Harney, has agreed to carry out a review of the operation, effectiveness and impact of the new fees amounts and rates, by 30th June 2010.
However, the IPU has warned of further disruption to patient services if the dispute is not resolved.
Further reading - A detailed review of the Irish pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
The Executive of the IPU said the industrial action had to end to prevent the recurrence of “chaotic scenes” which have occurred since many pharmacies withdrew their services on 1st August 2009 (See Ireland - Pay Cut Leads to Pharmaceutical Supply Crisis and Ireland - Pharmacy Row Taken to High Court).
The Minister for Health and Children, Mary Harney, has agreed to carry out a review of the operation, effectiveness and impact of the new fees amounts and rates, by 30th June 2010.
However, the IPU has warned of further disruption to patient services if the dispute is not resolved.
Further reading - A detailed review of the Irish pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
Tuesday, 25 August 2009
UK - Study Finds Huge Variations in Funding for Off-Label Cancer Drugs
There are huge variations in the way that NHS trusts are funding drug treatments for patients with rare cancers, according to a new report from the Rarer Cancers Forum, published on 14th August 2009.
Off-label treatments are often used in patients with rare cancers, as there are few licensed products for these specific cancers. Instead, the treatments prescribed are licensed for common cancer areas, but where the cancers have a similar underlying disease process. However, since the treatments necessary are not licensed for this use, patients must apply to their NHS trust to obtain them.
The report, Off limits - an investigation into NHS organisations’ policies and processes for determining requests for the use of off-label treatments for people with cancer, found that the opinion of trusts towards this form of prescribing, known as ‘near-label prescribing’, varies widely. It found that over the past three years, over 3,000 patients have applied to their Primary Care Trust (PCT) for funding for off-label treatments, and more than 1,000 have had their requests rejected. The study also assessed that patients with rare cancers in the UK are less likely to have access to off-label treatments than in France and Germany.
The report makes 25 recommendations for improvements, including:
Off-label treatments are often used in patients with rare cancers, as there are few licensed products for these specific cancers. Instead, the treatments prescribed are licensed for common cancer areas, but where the cancers have a similar underlying disease process. However, since the treatments necessary are not licensed for this use, patients must apply to their NHS trust to obtain them.
The report, Off limits - an investigation into NHS organisations’ policies and processes for determining requests for the use of off-label treatments for people with cancer, found that the opinion of trusts towards this form of prescribing, known as ‘near-label prescribing’, varies widely. It found that over the past three years, over 3,000 patients have applied to their Primary Care Trust (PCT) for funding for off-label treatments, and more than 1,000 have had their requests rejected. The study also assessed that patients with rare cancers in the UK are less likely to have access to off-label treatments than in France and Germany.
The report makes 25 recommendations for improvements, including:
- Near-label cancer treatments should be funded at the national level;
- Mandatory guidance should be issued to the NHS on the near-label treatments used most frequently; and
- The pharmaceutical industry should contribute to the costs of running the new system, provided that patients with rarer cancers benefit from improved access to medicines.
Further reading - A detailed review of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - 40% of PCTS are Not Providing Approved Blood Cancer Drugs
Just 60% of primary care trusts (PCTs) and 35% of local health boards (LHBs) routinely use therapies recommended by the National Institute for Health and Clinical Excellence (NICE), a survey from Leukaemia Care has shown.
The survey, published in August 2009, found that 23% of PCTs and 22% of LHBs are still making Velcade (bortezomib) and MabThera (rituximab) only available through Individual Funding Requests (IFR), despite the fact that they are both approved by NICE (although MabThera was only approved in July 2009), suggesting that they are not adequately following NICE’s guidelines.
Leukaemia Care also found there is confusion over which treatments to fund for blood cancer patients. The survey found that 39% of PCTs in England and 30% in Wales fund treatment with dasatinib, even though it has yet to be approved by NICE. It has, however, been approved by the All Wales Medicines Strategy Group (AWMSG) but the survey did not show that dasatinib was more routinely funded in Wales, as expected.
Leukaemia Care has expressed concern that PCTs and LHBs are not responding to NICE guidelines for haematological cancer treatments in the same way as they do for other therapies. The body has come up with a five-point plan to help develop a more consistent and transparent process for funding treatment across England and Wales. The five suggestions are:
The survey, published in August 2009, found that 23% of PCTs and 22% of LHBs are still making Velcade (bortezomib) and MabThera (rituximab) only available through Individual Funding Requests (IFR), despite the fact that they are both approved by NICE (although MabThera was only approved in July 2009), suggesting that they are not adequately following NICE’s guidelines.
Leukaemia Care also found there is confusion over which treatments to fund for blood cancer patients. The survey found that 39% of PCTs in England and 30% in Wales fund treatment with dasatinib, even though it has yet to be approved by NICE. It has, however, been approved by the All Wales Medicines Strategy Group (AWMSG) but the survey did not show that dasatinib was more routinely funded in Wales, as expected.
Leukaemia Care has expressed concern that PCTs and LHBs are not responding to NICE guidelines for haematological cancer treatments in the same way as they do for other therapies. The body has come up with a five-point plan to help develop a more consistent and transparent process for funding treatment across England and Wales. The five suggestions are:
- The provision of a central reference point for guidance on new treatments;
- The faster introduction of the NHS Constitution, which safeguards the right of patients in England to NICE endorsed therapies;
- The introduction of a specific requirement to collect data on the guidance implementation;
- Better guidance on the use of IFRs; and
- Setting up procedures to record data on the uptake of treatment ‘top-ups’.
Further reading - An in-depth analysis of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NICE Approves Use of Stelara for Psoriasis
The National Institute for Health and Clinical Excellence (NICE) approved the use of Stelara (ustekinumab) in the NHS in England and Wales, for adults with severe cases of psoriasis, in August 2009.
Janssen Cilag’s Stelara is a fully human monoclonal antibody and has been approved for use for patients who are considered to have severe psoriasis, according to the Psoriasis Area Severity Index (PASI) or the Dermatology Life Quality Index (DLQI). The therapy has also been approved for patients who are unresponsive or intolerant to other treatments such as ciclosporin and methotrexate.
In addition, the approval is under the condition of a pricing agreement with the manufacturer, whereby the 90mg vial necessary for patients weighing more than 100kg is provided at the same cost as the 45mg vial, to keep the cost per QALY at £9,335. NICE has also included in the guidance that treatment should be stopped in any patients who fail to show an adequate response to the drug after 16 weeks, judged as showing a 75% reduction in the PASI score, or a 50% drop alongside a 5-point lowering in the DLQI rating.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Janssen Cilag’s Stelara is a fully human monoclonal antibody and has been approved for use for patients who are considered to have severe psoriasis, according to the Psoriasis Area Severity Index (PASI) or the Dermatology Life Quality Index (DLQI). The therapy has also been approved for patients who are unresponsive or intolerant to other treatments such as ciclosporin and methotrexate.
In addition, the approval is under the condition of a pricing agreement with the manufacturer, whereby the 90mg vial necessary for patients weighing more than 100kg is provided at the same cost as the 45mg vial, to keep the cost per QALY at £9,335. NICE has also included in the guidance that treatment should be stopped in any patients who fail to show an adequate response to the drug after 16 weeks, judged as showing a 75% reduction in the PASI score, or a 50% drop alongside a 5-point lowering in the DLQI rating.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - HIV Drug Intelence Approved for Use on the NHS in Scotland
The Scottish Medicines Consortium (SMC) approved Intelence (etravirine) for patients with HIV under the NHS in Scotland, in August 2009.
Tibotec’s Intelence is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI), and the company claims that it is the first to show efficacy in those patients resistant to the first-generation NNRTI therapies.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on the SMC, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Tibotec’s Intelence is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI), and the company claims that it is the first to show efficacy in those patients resistant to the first-generation NNRTI therapies.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on the SMC, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Friday, 14 August 2009
China - Essential Medicines System May Lead to Market Expansion
China’s pharmaceutical market looks set to grow even further in the short-term, with the establishment of an Essential Medicines System during the 2009-2011 period. The plan calls for an estimated 300-400 essential medicines to be made available at all public facilities, starting at the grassroots level.
The system is modelled after the WHO List of Essential Medicines, and its establishment is designed to widen access to medicines to all citizens, as part of its plans to create universal healthcare for all by 2020. The system is part of China’s mammoth healthcare reform plan, for which it has allocated US$124 billion (850 billion yuan) to be spent over three years.
In China, pharmaceuticals are sold in hospitals and drugstores, and the healthcare reform plan will inevitably see access to pharmaceuticals increase, as it will also involve the construction of around 2,000 county level hospitals, so that each county will have at least one such facility, the construction of 29,000 township hospitals and upgrading of another 5,000. The government will also fund the construction of village clinics in remote areas so that every village will have at least one unit by the end of the three-year period. The plan also calls for 3,700 community health centres and 11,000 community health stations to be established or upgraded in cities.
The Essential Medicines System is part of the country’s return to its socialist roots, which saw the adoption of market driven policies since the 1980s. This led to an expansion of the Chinese economy, but also saw the rich-poor gap divide grow. Over 700 million people (55.1% of the total population in 2007) were classed as rural in China, and per capita income levels remain some of the world’s lowest.
Further reading - An in-depth review of the Chinese pharmaceutical market, including more detailed information on the healthcare reform plan, is available from Espicom: The Pharmaceutical Market: China (published July 2009)
The system is modelled after the WHO List of Essential Medicines, and its establishment is designed to widen access to medicines to all citizens, as part of its plans to create universal healthcare for all by 2020. The system is part of China’s mammoth healthcare reform plan, for which it has allocated US$124 billion (850 billion yuan) to be spent over three years.
In China, pharmaceuticals are sold in hospitals and drugstores, and the healthcare reform plan will inevitably see access to pharmaceuticals increase, as it will also involve the construction of around 2,000 county level hospitals, so that each county will have at least one such facility, the construction of 29,000 township hospitals and upgrading of another 5,000. The government will also fund the construction of village clinics in remote areas so that every village will have at least one unit by the end of the three-year period. The plan also calls for 3,700 community health centres and 11,000 community health stations to be established or upgraded in cities.
The Essential Medicines System is part of the country’s return to its socialist roots, which saw the adoption of market driven policies since the 1980s. This led to an expansion of the Chinese economy, but also saw the rich-poor gap divide grow. Over 700 million people (55.1% of the total population in 2007) were classed as rural in China, and per capita income levels remain some of the world’s lowest.
Further reading - An in-depth review of the Chinese pharmaceutical market, including more detailed information on the healthcare reform plan, is available from Espicom: The Pharmaceutical Market: China (published July 2009)
Ireland - Pharmacy Row Taken to High Court (UPDATE)
The High Court in Ireland has extended an injunction against 35 pharmacies on 10th August 2009, prohibiting them from withdrawing services under the Community Drug Schemes without the required notice of 30 days.
The injunction was sought by the Health Service Executive (HSE) against pharmacies in the Hickley and Bradley pharmacy groups, but the HSE has asserted that it will not hesitate to take action against any other pharmacies that breach their Community Pharmacy Contractor Agreements. The injunction hearing will be heard on September 9th 2009.
Around 500 pharmacies have terminated their contracts following pay cuts (see Ireland - Pay Cut Leads to Pharmaceutical Supply Crisis).
The Irish Pharmacy Union (IPU) has called the HSE’s decision to go to court “unhelpful”.
Mary Harney, the Minister for Health and Children, stated, “The new payment rates are now set in law. They have been in effect since 1st July. It is done. There will be no policy change, no change in the law to change the payment rates now.”
Ms Harney also said talks with the IPU were possible to resolve the dispute, but that mediation is not possible due to the High Court involvement, as “it is not possible to mediate law”.
Further reading - A detailed analysis of the Irish pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
The injunction was sought by the Health Service Executive (HSE) against pharmacies in the Hickley and Bradley pharmacy groups, but the HSE has asserted that it will not hesitate to take action against any other pharmacies that breach their Community Pharmacy Contractor Agreements. The injunction hearing will be heard on September 9th 2009.
Around 500 pharmacies have terminated their contracts following pay cuts (see Ireland - Pay Cut Leads to Pharmaceutical Supply Crisis).
The Irish Pharmacy Union (IPU) has called the HSE’s decision to go to court “unhelpful”.
Mary Harney, the Minister for Health and Children, stated, “The new payment rates are now set in law. They have been in effect since 1st July. It is done. There will be no policy change, no change in the law to change the payment rates now.”
Ms Harney also said talks with the IPU were possible to resolve the dispute, but that mediation is not possible due to the High Court involvement, as “it is not possible to mediate law”.
Further reading - A detailed analysis of the Irish pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
India - Authorities to Reimburse Costs of Drug Shipments which Avoid EU
The Indian government is to reimburse drugmakers for the extra costs incurred when shipping their products to developing nations and avoiding the European Union (EU), where a number of shipments have been confiscated recently, it was announced in August 2009.
More than 20 shipments of generic drugs, manufactured by companies such as Aurobindo, Cipla and Dr Reddy’s, have been seized in the past 16 months, according to government officials. Shipments were seized in the Netherlands, France, Germany and the UK while on their way to Asia, Africa and Latin America, after claims that they were breaching EU intellectual property (IP) laws.
India is issuing a formal complaint to the World Trade Organisation’s dispute settlement body, claiming that the EU has misused customs regulations to unlawfully seize the medicines. Particularly highlighted is EC Regulation 1383/2003, which is designed to protect the IP rights of EU member states and allows the seizure of shipments infringing IP regulations or if they are believed to be counterfeit.
A group of non-governmental organisations have called for the World Health Organisation (WHO) and the WTO to investigate the issue. They also pointed out that, under WTO rules, IP rights apply at the shipment’s departure and destination locations only, and so represent a violation of TRIPS Agreements.
Meanwhile, the EU, according to Oxfam, is pushing for the rules to be extended globally through free trade agreements and the Anti-Counterfeiting Trade Agreement (ACTA), which is currently being drawn up by 12 nations and the EU. This is due to start its sixth round of negotiations in South Korea in November 2009.
Further reading - An in-depth analysis of the Indian pharmaceutical market, including some background information on intellectual property and TRIPS regulations, is available from Espicom: The Pharmaceutical Market: India (published June 2009)
More than 20 shipments of generic drugs, manufactured by companies such as Aurobindo, Cipla and Dr Reddy’s, have been seized in the past 16 months, according to government officials. Shipments were seized in the Netherlands, France, Germany and the UK while on their way to Asia, Africa and Latin America, after claims that they were breaching EU intellectual property (IP) laws.
India is issuing a formal complaint to the World Trade Organisation’s dispute settlement body, claiming that the EU has misused customs regulations to unlawfully seize the medicines. Particularly highlighted is EC Regulation 1383/2003, which is designed to protect the IP rights of EU member states and allows the seizure of shipments infringing IP regulations or if they are believed to be counterfeit.
A group of non-governmental organisations have called for the World Health Organisation (WHO) and the WTO to investigate the issue. They also pointed out that, under WTO rules, IP rights apply at the shipment’s departure and destination locations only, and so represent a violation of TRIPS Agreements.
Meanwhile, the EU, according to Oxfam, is pushing for the rules to be extended globally through free trade agreements and the Anti-Counterfeiting Trade Agreement (ACTA), which is currently being drawn up by 12 nations and the EU. This is due to start its sixth round of negotiations in South Korea in November 2009.
Further reading - An in-depth analysis of the Indian pharmaceutical market, including some background information on intellectual property and TRIPS regulations, is available from Espicom: The Pharmaceutical Market: India (published June 2009)
USA - FDA Raises Access to Unapproved Drugs
The US Food and Drug Administration (FDA) issued new rules which will make it easier for seriously ill patients to receive unapproved investigational drugs, in August 2009.
The new rules apply to those patients who have no other treatment options available to them and are not eligible to participate in a clinical trial. There will also be a new website created for patients to find out more about access to investigational medicines.
Manufacturers will be able to charge for expanded access to such drugs, and the FDA hopes the move will encourage more pharmaceutical companies to develop investigational medicines.
The changes will not result in changes to the FDA’s drug approval processes, but are expected to increase applications for investigational drugs by up to 50%.
Further reading - A detailed analysis of the US pharmaceutical market, including some background information on the FDA, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
The new rules apply to those patients who have no other treatment options available to them and are not eligible to participate in a clinical trial. There will also be a new website created for patients to find out more about access to investigational medicines.
Manufacturers will be able to charge for expanded access to such drugs, and the FDA hopes the move will encourage more pharmaceutical companies to develop investigational medicines.
The changes will not result in changes to the FDA’s drug approval processes, but are expected to increase applications for investigational drugs by up to 50%.
Further reading - A detailed analysis of the US pharmaceutical market, including some background information on the FDA, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
UK - United Drug and Medco Health Solutions Join Forces to Provide Home-Based Pharmacy Care
United Drug agreed a deal with Medco Health Solutions to provide home-based pharmacy care services in the UK, in August 2009.
The joint project will provide a range of services to NHS patients, including prescription drug dispensing and home delivery and on-site nursing care for the administration of oral, injectable and infused agents.
Currently homecare pharmacy services comprise around £1.6 billion of the UK’s prescription drug spending. Investments in services such as these have grown at an annual rate of over 20% over the past five years.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on pharmacy services, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The joint project will provide a range of services to NHS patients, including prescription drug dispensing and home delivery and on-site nursing care for the administration of oral, injectable and infused agents.
Currently homecare pharmacy services comprise around £1.6 billion of the UK’s prescription drug spending. Investments in services such as these have grown at an annual rate of over 20% over the past five years.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on pharmacy services, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NICE Approves Alimta for NHS Use
The National Institute for Health and Clinical Excellence (NICE) recommended Alimta (pemetrexed) for use in patients with non-small cell lung cancer in August 2009.
Eli Lilly’s Alimta can be used in combination with cisplatin on the NHS as a first-line treatment of locally advanced or metastatic NSCLC if the tumour has been confirmed as adenocarcinoma or large-cell carcinoma. In total, around 80% of lung cancers are the NSCLC type, and these are made up of squamous cell carcinoma (45%), adenocarcinoma (45%) and large cell carcinoma (10%).
Currently, the NHS treatment for NSCLC is Eli Lilly’s chemotherapy Gemzar (gemcitabine), which holds an 85% market share, followed by vinorelbine with an 11% market share.
NICE originally rejected Alimta in 2007, on the grounds that there was no evidence that the drug was more clinically or cost-effective than the other treatments already available.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Eli Lilly’s Alimta can be used in combination with cisplatin on the NHS as a first-line treatment of locally advanced or metastatic NSCLC if the tumour has been confirmed as adenocarcinoma or large-cell carcinoma. In total, around 80% of lung cancers are the NSCLC type, and these are made up of squamous cell carcinoma (45%), adenocarcinoma (45%) and large cell carcinoma (10%).
Currently, the NHS treatment for NSCLC is Eli Lilly’s chemotherapy Gemzar (gemcitabine), which holds an 85% market share, followed by vinorelbine with an 11% market share.
NICE originally rejected Alimta in 2007, on the grounds that there was no evidence that the drug was more clinically or cost-effective than the other treatments already available.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Foundation Trusts’ Spending Plans are Over-Optimistic
Foundation trusts were warned that their spending plans up to 2012 are overly optimistic, by Monitor, the regulator of foundation trusts, in August 2009. The trusts have been asked to also submit a downside forecast, which will give a more realistic projection of future spending growth.
Overall, 115 trusts have forecast a growth in their income of 4.2% in 2009/10, 2.1% in 2010/11 and 1.6% in 2011/12. It is known that NHS funding will increase in the next two years but funding post-2011 has not yet been finalised.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NHS funding, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Overall, 115 trusts have forecast a growth in their income of 4.2% in 2009/10, 2.1% in 2010/11 and 1.6% in 2011/12. It is known that NHS funding will increase in the next two years but funding post-2011 has not yet been finalised.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NHS funding, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Thursday, 6 August 2009
Ireland - Pay Cut Leads to Pharmaceutical Supply Crisis
Patients enrolled in Ireland’s Community Drugs Schemes have been encountering problems when trying to obtain their prescriptions since August 1st, as many pharmacists have stopped dispensing medicines under the schemes.
The action by the pharmacists follows the decision by Mary Harney, the Minister for Health and Children, to cut payments to pharmacists under the Schemes by 34% as a result of the financial crisis. Under the Financial Emergency Measures in the Public Interest Act 2009, the Minster announced on 18th June that payments would be reduced by 55 million euros to 495 million euros. This is similar to the amount received in 2006.
It was expected that up to 1,100 community pharmacists would stop dispensing medicines under the schemes.
Liz Hoctor, president of the Irish Pharmacy Union (IPU), said that the contingency plans put into place by the Health Service Executive (HSE) have been “totally inadequate”.
Meanwhile, Laverne McGuinness, the HSE’s national director of primary care, has accused the IPU of deliberately using inaccurate information to cause anxiety among patients, which “reflects very badly on the profession”.
Further reading - A detailed analysis of the Irish pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
The action by the pharmacists follows the decision by Mary Harney, the Minister for Health and Children, to cut payments to pharmacists under the Schemes by 34% as a result of the financial crisis. Under the Financial Emergency Measures in the Public Interest Act 2009, the Minster announced on 18th June that payments would be reduced by 55 million euros to 495 million euros. This is similar to the amount received in 2006.
It was expected that up to 1,100 community pharmacists would stop dispensing medicines under the schemes.
Liz Hoctor, president of the Irish Pharmacy Union (IPU), said that the contingency plans put into place by the Health Service Executive (HSE) have been “totally inadequate”.
Meanwhile, Laverne McGuinness, the HSE’s national director of primary care, has accused the IPU of deliberately using inaccurate information to cause anxiety among patients, which “reflects very badly on the profession”.
Further reading - A detailed analysis of the Irish pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
UK - NICE Rejects Celgene’s Vidaza
The National Institute for Health and Clinical Excellence (NICE) rejected Vidaza (azacitidine) as a treatment for blood cancers in August 2009, because it is not a cost-effective use of NHS resources.
Celgene’s Vidaza is used to treat myelodysplastic syndromes (MDS), including chronic myelomonocytic leukaemia (CML) and acute myeloid leukaemia (AML). However, NICE considered it too costly for use among NHS patients, despite agreeing that the drug is clinically effective and even taking into account recent guidelines on appraising end-of-life treatments.
The recommendations can be contested up until August 24th and there will be a Second Appraisal Committee meeting on September 3rd.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Celgene’s Vidaza is used to treat myelodysplastic syndromes (MDS), including chronic myelomonocytic leukaemia (CML) and acute myeloid leukaemia (AML). However, NICE considered it too costly for use among NHS patients, despite agreeing that the drug is clinically effective and even taking into account recent guidelines on appraising end-of-life treatments.
The recommendations can be contested up until August 24th and there will be a Second Appraisal Committee meeting on September 3rd.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Dentists’ Earnings Published
The NHS Information Centre has published the earnings of dentists in England and Wales. The 2007/08 Dental Earnings and Expenses Report, England and Wales, details the earnings and expenses of self-employed primary care dentists. The report looked at Providing-Performer dentists, who had a contract with a local health body and performed other dental services, and Performer Only dentists, who performed dental services but did not have a contract.
The report revealed that a total of 382 dentists out of 20,000 had a gross income of over £300,000 between 2007 and 2008, and 1,172 had gross earnings of more than £200,000 over the course of the year. It also highlighted a pay difference between dentists in England and Wales, with the average pay in England being £88,870 and the average in Wales being £93,924.
The key findings of the report are:
The report revealed that a total of 382 dentists out of 20,000 had a gross income of over £300,000 between 2007 and 2008, and 1,172 had gross earnings of more than £200,000 over the course of the year. It also highlighted a pay difference between dentists in England and Wales, with the average pay in England being £88,870 and the average in Wales being £93,924.
The key findings of the report are:
- The average taxable income for Providing-Performer dentists was £126,807, compared to £65,697 for Performer Only dentists. The overall average was £89,062;
- The average expenses for Providing-Performer dentists were £218,843, compared to just £33,512 for Performer Only dentists; and
- The average gross earnings for Providing Performer dentists were £345,651, compared to £99,208 for Performer Only dentists.
Further reading - A detailed review of the UK pharmaceutical market, including some background information on dentistry, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Wednesday, 5 August 2009
UK - NHS Faces Bill of £400 million for Private Contracts
The NHS is facing a bill of £400 million in the next two years, when independent sector treatment centre (ISTC) contracts with private sector operators expire.
Around £200 million will be paid for operation capacity bought by Primary Care Trusts (PCTs) but not used, as it is estimated that the health service only delivered around 85% of the agreed number of operations. A further £200 million will be paid to buy the premises built by the private sector operators.
Since ISTCs opened in 2005, they have cut waiting lists and introduced competition. So far, they have provided more than 1.7 million operations and other procedures, helping to cut the maximum NHS waiting time to 18 weeks.
ISTCs were originally commissioned by the Department of Health. They offered a five-year deal guaranteeing volumes of patients, with a buy-back clause on the buildings, and prices around 11% higher than NHS prices.
It will now be up to PCTs to decide if they want to renew the contracts, under different terms, most likely with no guarantees of volume and standard NHS prices.
Health Minister Mike O’Brien insisted that the initiative had been value for money, claiming it had cleared a backlog of 250,000 NHS patients who had to be treated to reduce waiting times. He told the Financial Times, “We wanted to ensure we had sufficient capacity. And if you hit your target, as we have, you have value for money.”
Further reading - A detailed review of the UK pharmaceutical market, including some background information on healthcare infrastructure, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Around £200 million will be paid for operation capacity bought by Primary Care Trusts (PCTs) but not used, as it is estimated that the health service only delivered around 85% of the agreed number of operations. A further £200 million will be paid to buy the premises built by the private sector operators.
Since ISTCs opened in 2005, they have cut waiting lists and introduced competition. So far, they have provided more than 1.7 million operations and other procedures, helping to cut the maximum NHS waiting time to 18 weeks.
ISTCs were originally commissioned by the Department of Health. They offered a five-year deal guaranteeing volumes of patients, with a buy-back clause on the buildings, and prices around 11% higher than NHS prices.
It will now be up to PCTs to decide if they want to renew the contracts, under different terms, most likely with no guarantees of volume and standard NHS prices.
Health Minister Mike O’Brien insisted that the initiative had been value for money, claiming it had cleared a backlog of 250,000 NHS patients who had to be treated to reduce waiting times. He told the Financial Times, “We wanted to ensure we had sufficient capacity. And if you hit your target, as we have, you have value for money.”
Further reading - A detailed review of the UK pharmaceutical market, including some background information on healthcare infrastructure, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Report Forecasts Future for NHS Funding
A report into the possible future of NHS funding was published in July 2009. The report, How cold will it be? Prospects for NHS Funding: 2011-17, by The King’s Fund and Institute for Fiscal Studies, analyses how much of an impact the economic recession could have on NHS funding. Public spending will be inevitably hit by the financial crisis, and the report analyses the different outcomes this could have on the NHS in England between 2011/12 to 2016/17.
There are three possible funding outcomes over the next two spending review periods:
The report notes that demographic pressures, including a rising and ageing population, are likely to cost the NHS around £1.0-1.4 billion extra each year at 2010/11 prices, and would require funding increases of around 1.1% to maintain quality. Only the ‘tepid’ scenario would provide enough money to cover this. These pressures are also adding to the demands placed on the healthcare system, and the report argues that productivity gains are essential, regardless of the future funding of the NHS.
The report notes that the NHS could fill this gap in funding with increased productivity levels. However, these would need to be significant if they were to make an impact. The report states that over the period between 2011 and 2017, the NHS would need to make gains of between £21.6 billion and £47.0 billion, equivalent to improvements of 3.4% to 7.4% per year, or £3.6 billion to £7.8 billion per year.
The report argues that the NHS in England is in some ways better prepared than ever to deal with the downturn. Current funding levels mean that it has employed more professionals, there have been huge improvements in the infrastructure and waiting times have been dramatically reduced.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NHS funding, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
There are three possible funding outcomes over the next two spending review periods:
- ‘Tepid’ – annual real increases of 2% for the first three years, increasing to 3% for the final three years;
- ‘Cold’ – zero real change; and
- ‘Arctic’ – annual real reductions of 2% for the first three years, falling to 1% for the final three years.
The financial future of the NHS remains uncertain, and depends on the extent of tax increases and productivity levels. The report notes that over the next spending review period (2011/12-2013/14) the budget could reduce for all government areas, including the NHS, by an average of 2.3% per year. If the NHS were to be protected by a greater or lesser degree, this could result in greater cuts for other departments, although this could be lessened by an increase in taxes.
The changes to the budget could have implications on taxation. Even the ‘tepid’ scenario would require an increase in taxation (or reduction in spending on social security benefits and tax credits) of £6.9 billion, which would be equivalent to £220 extra per family, or raised through a 1.6% increase in the level of VAT.The report notes that demographic pressures, including a rising and ageing population, are likely to cost the NHS around £1.0-1.4 billion extra each year at 2010/11 prices, and would require funding increases of around 1.1% to maintain quality. Only the ‘tepid’ scenario would provide enough money to cover this. These pressures are also adding to the demands placed on the healthcare system, and the report argues that productivity gains are essential, regardless of the future funding of the NHS.
The report notes that the NHS could fill this gap in funding with increased productivity levels. However, these would need to be significant if they were to make an impact. The report states that over the period between 2011 and 2017, the NHS would need to make gains of between £21.6 billion and £47.0 billion, equivalent to improvements of 3.4% to 7.4% per year, or £3.6 billion to £7.8 billion per year.
The report argues that the NHS in England is in some ways better prepared than ever to deal with the downturn. Current funding levels mean that it has employed more professionals, there have been huge improvements in the infrastructure and waiting times have been dramatically reduced.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NHS funding, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Kennedy’s Innovation Report Published
A study into innovation within the pharmaceutical industry was presented to a NICE board meeting by Sir Ian Kennedy on July 22nd 2009.
The report outlines recommendations on how NICE can ensure its appraisal procedures take innovation into account and how innovation should be defined. It was commissioned in response to a report by Sir David Cooksey, Review and Refresh of Bioscience 2015, which called for an independent review into the importance of innovative medicines and new health technologies.
Sir Ian is particularly critical of the recent change to NICE’s consideration of end-of-life treatments, warning that they could represent a ‘Trojan horse’ making it increasingly difficult for NICE to withhold approval.
The recommendations have some similarities with the idea of an Innovation Pass, which would allow some drugs to be made available on the NHS without having gone through a NICE appraisal, as proposed in the Office for Life Sciences Blueprint on 14th July 2009.
Some of the recommendations are:
The report outlines recommendations on how NICE can ensure its appraisal procedures take innovation into account and how innovation should be defined. It was commissioned in response to a report by Sir David Cooksey, Review and Refresh of Bioscience 2015, which called for an independent review into the importance of innovative medicines and new health technologies.
Sir Ian is particularly critical of the recent change to NICE’s consideration of end-of-life treatments, warning that they could represent a ‘Trojan horse’ making it increasingly difficult for NICE to withhold approval.
The recommendations have some similarities with the idea of an Innovation Pass, which would allow some drugs to be made available on the NHS without having gone through a NICE appraisal, as proposed in the Office for Life Sciences Blueprint on 14th July 2009.
Some of the recommendations are:
- NICE’s appraisals should continue to be based on the ICER/QALY approach into which is incorporated explicit consideration of relevant benefits. A two-stage approach should not be adopted;
- NICE should consult all relevant parties and draw up a list of those health-related benefits to be taken into account in its appraisals. The list should be reviewed through an appropriate mechanism from time to time;
- Social benefits should not currently be taken account of by NICE in its appraisals, but NICE should commission or participate in research to determine whether such benefits could form part of NICE’s approach and, if so, how;
- NICE should work with others to develop an active policy on disinvestment by the NHS in products which do not offer value for money;
- NICE should formulate a definition of ‘innovation’. So that a judgement can be made that a product meets the NHS’ needs, the Secretary of State for Health should from time to time make explicit the priorities of the NHS regarding intervention and treatment;
- NICE should establish a mechanism whereby pharmaceutical companies can signal as early as possible that a product may constitute an ‘innovation’. NICE should work closely with pharmaceutical companies, using for example its scientific advice programme, to ensure that the data required by NICE to make this judgement is generated. NICE should offer advice and support to newer companies to facilitate competition in the sector. NICE should consider, as incentives to pharmaceutical companies, agreeing a higher threshold in the case of ‘innovation’ (as defined) and maintaining it for a fixed period or agreeing the use of a scheme under the revised PPRS (flexible pricing or patient access). NICE should revisit the threshold to be used in the appraisal of products which do not meet the criteria of innovation if a higher threshold or one of the schemes under the PPRS is used as an incentive to promote innovation;
- NICE should establish a mechanism whereby the NHS is compensated for the financial loss incurred, if a product subsequently proves not to meet initial expectations;
- NICE should build on its reputation as leading the world in the appraisal of products to establish itself also as a world leader in promoting innovation and the early adoption of treatments;
- NICE should urge government to make appropriate adjustments to the supply side, as recommended by Sir David Cooksey and the Office of Life Sciences to encourage innovation on behalf of the NHS and patients;
- NICE should only offer incentives for innovation when it is realised;
- NICE should consider establishing a formal and transparent process, using such options available to it to offer incentives to pharmaceutical companies when a product is said to have the promise of innovation. NICE should pilot the process for a period of time if it decides to establish it;
- NICE should work with the Office of Life Sciences such that, if an ‘innovation pass’ is thought necessary and appropriate, conditions apply. NICE should establish a committee of experts to advise on whether the criteria for use of the ‘innovation pass’ are met. NICE should seek to ensure that funding for the purchase of the products subject to the ‘innovation pass’ comes from a specially created fund and not from the NHS. NICE should seek to ensure that the ‘innovation pass’ during which a product is not evaluated by NICE should last for a fixed period of time (e.g. a maximum of three years). NICE should seek to ensure that at the expiry of the fixed period of time the product is appraised by NICE and falls within the threshold for approval;
- NICE through its Medical Technology Advisory Committee should play an increasingly active role in encouraging research into medical technologies to be carried out in the UK.
NICE will issue a formal response in September, which will be followed by a three-month public consultation.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Number of Prescriptions Increase but Costs Fall
Prescriptions dispensed in England rose by 5.8% in 2008, while costs fell by 0.6%, according to figures from the NHS Information Centre released in July 2009.
In 2008, a total of 842.5 million prescriptions were dispensed, a rise of 5.8% over 2007, while the net ingredient cost of all prescriptions decreased by 0.6% to £8,325.5 million. Over the same period, the average net ingredient cost per prescription item fell by 6.0% to £9.88.
The leading BNF Chapter in terms of volume was the cardiovascular system, and in terms of cost was the central nervous system. The leading BNF Section in terms of prescription items dispensed was hypertension and heart failure and in terms of cost was drugs used in diabetes.
A total of 65.0% of prescription items were dispensed generically in 2008, representing 26.2% of the total cost.
Further reading - An in-depth analysis of the UK pharmaceutical market, including data on prescriptions dispensed, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
In 2008, a total of 842.5 million prescriptions were dispensed, a rise of 5.8% over 2007, while the net ingredient cost of all prescriptions decreased by 0.6% to £8,325.5 million. Over the same period, the average net ingredient cost per prescription item fell by 6.0% to £9.88.
The leading BNF Chapter in terms of volume was the cardiovascular system, and in terms of cost was the central nervous system. The leading BNF Section in terms of prescription items dispensed was hypertension and heart failure and in terms of cost was drugs used in diabetes.
A total of 65.0% of prescription items were dispensed generically in 2008, representing 26.2% of the total cost.
Further reading - An in-depth analysis of the UK pharmaceutical market, including data on prescriptions dispensed, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - 2008 Pharmacy Workforce Census Published
A census of the working patterns of pharmacists was published in July 2009. The fourth Pharmacy Workforce Census, compiled by the Royal Pharmaceutical Society of Great Britain, studied pharmacists registered in August 2008.
The survey had a high response rate of 69.6%. The key findings were:
The survey had a high response rate of 69.6%. The key findings were:
- The Register increased by 1.7% between August 2007 and August 2008, which continues an upward trend since 1991;
- Pharmacists reported working the same number of hours on average as the 2005 census (35 hours), although men worked longer hours than women. The proportion of pharmacists working 49 hours or more per week increased by 1% since the previous census;
- There was an increase in the number of pharmacists working part-time, representing 32.3% of the working population. Part-time working, defined as 32 hours or less, was most prevalent in the primary care sector, with a total of 39.5%;
- Around 41.9% of pharmacists reported working long hours, and this figure rose to 52.2% for male pharmacists;
- Almost a third of pharmacists (30.3%) felt they did not have enough time to socialise outside of work, and a similar proportion (30.7%) wanted to reduce their working hours but felt they had no control;
- Male pharmacists perceived that they experienced more problems with a work-life balance than female pharmacists, apart from in the case of part-time work when the opposite was true;
- More than one in ten pharmacists (13.0%) are considering leaving the sector within the next two years, and a similar proportion (10.9%) are considering quitting the profession altogether.
The findings will be used to help inform workforce planning and policy development across the profession, under the General Pharmaceutical Council (GPhC) which is to be established in 2010. The research was undertaken by a team at the School of Pharmacy, University of Manchester and funded by the Department of Health.
Further reading - A detailed review of the pharmaceutical market in the UK, including some background information on pharmacists, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - Experts Call for Consultation on Generic Substitution
Experts have called for a consultation on the effects of generic substitution, proposed to take effect from January 2010 as part of the Pharmaceutical Price Regulation Scheme (PPRS).
A report, which calls into question the proposal to introduce generic substitution, was endorsed by a varied group of experts and patient bodies in July 2009. The Department of Health plans to introduce generic substitution in January 2010, as stated in the PPRS, to drive down costs and reduce the NHS’ drugs bill. However, those opposing the move claim it will in fact increase costs and put patient safety at risk.
The report, which was compiled by CancerBACUP, the Primary Care Dermatology Society and the European Parkinson’s Disease Society, and was funded by Norgine, argues that the move could lead to patient confusion and, crucially, to poorer patient outcomes.
The report calls for a public consultation on “the practical impact of generic substitution on patients adherence and outcomes and the potential impact of varying bioavailability on outcomes and adverse events”.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the PPRS, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
A report, which calls into question the proposal to introduce generic substitution, was endorsed by a varied group of experts and patient bodies in July 2009. The Department of Health plans to introduce generic substitution in January 2010, as stated in the PPRS, to drive down costs and reduce the NHS’ drugs bill. However, those opposing the move claim it will in fact increase costs and put patient safety at risk.
The report, which was compiled by CancerBACUP, the Primary Care Dermatology Society and the European Parkinson’s Disease Society, and was funded by Norgine, argues that the move could lead to patient confusion and, crucially, to poorer patient outcomes.
The report calls for a public consultation on “the practical impact of generic substitution on patients adherence and outcomes and the potential impact of varying bioavailability on outcomes and adverse events”.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the PPRS, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NICE Approves Basilea’s Toctino
The National Institute for Health and Clinical Excellence (NICE) approved Toctino (alitretinoin) as a treatment for eczema in July 2009. The Swiss group Basilea’s Toctino has been approved under the NHS for adults with severe hand eczema, with a dermatology life quality index score of 15 or more, who have failed to respond to therapy with topical corticosteroids. The drug, which costs £411.43 for a pack of 30 x 30mg capsules (excluding VAT), is considered a cost-effective use of resources as the cost per QALY is well below the threshold required.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NICE Publishes Guidance on Tenofovir Disoproxil
The National Institute for Health and Clinical Excellence (NICE) has published guidance on tenofovir disoproxil, recommending it for use in patients for whom antiviral treatment is indicated with chronic HBeAg-positive or HBeAg-negative hepatitis B. However, the guidance does not apply to patients with chronic hepatitis B who also have hepatitis C, hepatitis D or HIV.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
UK - NICE Publishes Guidance on Rituximab
The National Institute for Health and Clinical Excellence (NICE) has published guidance on rituximab, recommending it as a first-line treatment for patients with chronic lymphocytic leukaemia, who are able to take fludarabine in combination with cyclophosphamide. The guidance states that rituximab is not recommended in combination with any other chemotherapy agents.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
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