Three major hospital associations have agreed to contribute US$155 billion over ten years to the healthcare reform, it was announced on 8th July 2009.
Vice President Joe Biden did not provide specific details, but said the savings would come from delivery system reforms and trimming the annual inflationary adjustments to hospital reimbursement payments from two government health programmes.
It is expected that around US$100 billion will come from lower Medicare and Medicaid payments to hospitals, while a further US$40 billion will be saved by reducing the subsidies paid to hospitals to care for the uninsured.
The three hospital associations participating in the deal are the American Hospital Association, the Hospital Corporation of America and the Catholic Health Association of the United States.
The deal is similar to the agreement made with the pharmaceutical industry in June 2009, under which drug companies agreed to contribute US$80 billion over ten years towards the costs of the healthcare reform. However, both deals are contingent on the healthcare reform legislation being passed.
Further reading - An in-depth review of the US pharmaceutical market, including some background information on the healthcare system, is available from Espicom: The Pharmaceutical Market: USA (published March 2009)
Monday, 13 July 2009
EU – Competition Inquiry Findings Released
The results of the EU Commission’s 18-month long inquiry into anti-competitive conditions in the pharmaceutical industry were released on 8th July 2009.
The inquiry, launched in January 2008, found that generic medicines take too long to reach the market, and this is often due to drug companies using a variety of techniques to extend the commercial life of their products. Between 2000 and 2007, consumers waited an average of seven months for a cheaper generic medicine once the patent had expired, costing 20% in extra spending. The EU Commission called upon member states to do more to boost the uptake of generic medicines, but will also scrutinise the sector more closely and prosecute any companies which violate the competition law.
The first settlement agreement to be investigated is between French-based Servier and a number of generic companies including Teva, Krka, Lupin, Mylan’s Matrix subsidiary and Unichem’s Niche Generics unit, over “possibly restrictive” practices which may have hindered the entry of the generic versions of Servier’s cardiovascular drug perindopril.
The EU Commission is expected to review around 200 such agreements in the coming months.
The inquiry also found that fewer innovative medicines are reaching the market, and that certain drug company’s practices may be contributing to this. The EU Commission said it will monitor the situation closely to identify the factors contributing to the decline in innovation.
The inquiry also concluded that there is an urgent need for an EU patent and patent-litigation system, which will reduce costs and improve efficiency. It will also reduce uncertainty for drug companies, because at present, 30% of patent court cases are conducted in parallel in several member states, and in 11% of cases national courts reach conflicting judgements.
Further reading - Pharmaceutical market profiles are available for all European countries from Espicom: Pharmaceutical Market Reports; Europe
The inquiry, launched in January 2008, found that generic medicines take too long to reach the market, and this is often due to drug companies using a variety of techniques to extend the commercial life of their products. Between 2000 and 2007, consumers waited an average of seven months for a cheaper generic medicine once the patent had expired, costing 20% in extra spending. The EU Commission called upon member states to do more to boost the uptake of generic medicines, but will also scrutinise the sector more closely and prosecute any companies which violate the competition law.
The first settlement agreement to be investigated is between French-based Servier and a number of generic companies including Teva, Krka, Lupin, Mylan’s Matrix subsidiary and Unichem’s Niche Generics unit, over “possibly restrictive” practices which may have hindered the entry of the generic versions of Servier’s cardiovascular drug perindopril.
The EU Commission is expected to review around 200 such agreements in the coming months.
The inquiry also found that fewer innovative medicines are reaching the market, and that certain drug company’s practices may be contributing to this. The EU Commission said it will monitor the situation closely to identify the factors contributing to the decline in innovation.
The inquiry also concluded that there is an urgent need for an EU patent and patent-litigation system, which will reduce costs and improve efficiency. It will also reduce uncertainty for drug companies, because at present, 30% of patent court cases are conducted in parallel in several member states, and in 11% of cases national courts reach conflicting judgements.
Further reading - Pharmaceutical market profiles are available for all European countries from Espicom: Pharmaceutical Market Reports; Europe
UK - NICE Rejects Drug for Soft Tissue Carcinoma
NHS patients with advanced soft tissue carcinoma will not have access to Yondelis (trabectedin) because it is not cost-effective, the National Institute for Health and Clinical Excellence (NICE) ruled in July 2009.
Spanish drugmaker Zeltia’s Yondelis is an alkylating agent that damages the DNA of cancer cells.
Under new rules unveiled in January 2009, NICE is now more flexible when considering drugs for end-of-life care. However, despite agreeing that Yondelis meets the criteria for being a life-extending, end-of-life treatment which could increase patient survival by up to three months, NICE concluded that the benefits do not justify use of NHS resources as the drug is still not cost-effective.
A second appraisal committee meeting is scheduled for 4th August 2009, with comments on the consultation taken up until 21st July 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 March 2009)
Spanish drugmaker Zeltia’s Yondelis is an alkylating agent that damages the DNA of cancer cells.
Under new rules unveiled in January 2009, NICE is now more flexible when considering drugs for end-of-life care. However, despite agreeing that Yondelis meets the criteria for being a life-extending, end-of-life treatment which could increase patient survival by up to three months, NICE concluded that the benefits do not justify use of NHS resources as the drug is still not cost-effective.
A second appraisal committee meeting is scheduled for 4th August 2009, with comments on the consultation taken up until 21st July 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 March 2009)
UK – NICE to Reconsider Guidance on Tyverb after GSK Appeal
The National Institute for Health and Clinical Excellence (NICE) has agreed to uphold an appeal from GlaxoSmithKline over guidance rejecting Tyverb (lapatinib) as a treatment for patients with advanced breast cancer.
Final guidance was issued in March 2009 on the drug, which did not recommend Tyverb on the grounds that it showed just “a small overall benefit” with a cost per QALY (quality assured life year) of £70,000, and therefore was not cost effective.
However, GlaxoSmithKline appealed against the recommendation and claimed that the drug was a cost-effective therapy when combined with chemotherapy and the company’s proposed patient access scheme. Under this scheme, the drug company would pay for the first 12 weeks of Tyverb treatment which would result in a QALY of £16,000.
As a result, NICE has agreed to re-assess the drug as part of the new guidance to be used when assessing end-of-life care, introduced in January 2009. This includes allowing companies and other stakeholders the right to submit evidence which they believe proves their product is cost-effective.
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 March 2009)
Final guidance was issued in March 2009 on the drug, which did not recommend Tyverb on the grounds that it showed just “a small overall benefit” with a cost per QALY (quality assured life year) of £70,000, and therefore was not cost effective.
However, GlaxoSmithKline appealed against the recommendation and claimed that the drug was a cost-effective therapy when combined with chemotherapy and the company’s proposed patient access scheme. Under this scheme, the drug company would pay for the first 12 weeks of Tyverb treatment which would result in a QALY of £16,000.
As a result, NICE has agreed to re-assess the drug as part of the new guidance to be used when assessing end-of-life care, introduced in January 2009. This includes allowing companies and other stakeholders the right to submit evidence which they believe proves their product is cost-effective.
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 March 2009)
UK – UCB Opens £25 million R&D Centre in UK
Belgium-based UCB has opened its new £25 million biologics Research and Development centre in Slough, UK. The company, headquartered in Brussels, said the centre will be used for research into therapeutic antibodies. UCB will employ 100 scientists, in addition to the staff already employed at the site.
The new UCB New Medicines Centre for Collaborative Research will also be located within the biologics centre.
UCB claims to be the fourth largest investor in UK pharmaceutical Research and Development, investing over £200 million in 2008.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on drug companies and Research and Development, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
The new UCB New Medicines Centre for Collaborative Research will also be located within the biologics centre.
UCB claims to be the fourth largest investor in UK pharmaceutical Research and Development, investing over £200 million in 2008.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on drug companies and Research and Development, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
Friday, 3 July 2009
UK - Roche Withdraws from Industry Association
The British arm of the Swiss company Roche has decided not to renew its membership of the Association of the British Pharmaceutical Industry (ABPI), it was announced in June 2009.
Roche’s move follows a six-month suspension for a serious breach of the ABPI’s code of practice, related to selling its slimming drug Xenical (orlistat) to private clinics. Roche was also criticised for failing to stop a programme which offered incentives for patients to take its treatment for cystic fibrosis, but, in light of the suspension, no further action was taken. The suspension ended in February 2009.
Although Roche has pledged to continue to comply with the ABPI’s Code of Practice, it removes the option for the ABPI to order similar sanctions if the company breaks the code in the future.
The Medicines and Healthcare Regulatory Products Agency (MHRA) can prosecute drug companies, but up until now the majority of disciplinary action has been taken by the Prescription Medicines Code of Practice Authority, run by the ABPI.
In a statement, Roche said: “In line with any commercial business we continually review our operations, and our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs in the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being. We will continue to review this situation.”
It also noted: “This decision in no way affects our commitment to our working practices and we are still committed to, and will be accountable for, working within the ABPI Code of Practice to ensure compliance with the high standards of our industry.”
The statement also said that a set of new processes and procedures for compliance had been put in place, with a team of eight staff dedicated to compliance, and training is now given to staff so that they fully understand the Code of Practice and the company’s internal policies for complying with it.
However the ABPI, which receives a six-figure subscription from Roche, is disputing the company’s right to leave, and crucially, the decision has raised questions over the organisation’s ability to regulate the industry at arm’s length.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the regulatory environment and the ABPI, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
Roche’s move follows a six-month suspension for a serious breach of the ABPI’s code of practice, related to selling its slimming drug Xenical (orlistat) to private clinics. Roche was also criticised for failing to stop a programme which offered incentives for patients to take its treatment for cystic fibrosis, but, in light of the suspension, no further action was taken. The suspension ended in February 2009.
Although Roche has pledged to continue to comply with the ABPI’s Code of Practice, it removes the option for the ABPI to order similar sanctions if the company breaks the code in the future.
The Medicines and Healthcare Regulatory Products Agency (MHRA) can prosecute drug companies, but up until now the majority of disciplinary action has been taken by the Prescription Medicines Code of Practice Authority, run by the ABPI.
In a statement, Roche said: “In line with any commercial business we continually review our operations, and our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs in the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being. We will continue to review this situation.”
It also noted: “This decision in no way affects our commitment to our working practices and we are still committed to, and will be accountable for, working within the ABPI Code of Practice to ensure compliance with the high standards of our industry.”
The statement also said that a set of new processes and procedures for compliance had been put in place, with a team of eight staff dedicated to compliance, and training is now given to staff so that they fully understand the Code of Practice and the company’s internal policies for complying with it.
However the ABPI, which receives a six-figure subscription from Roche, is disputing the company’s right to leave, and crucially, the decision has raised questions over the organisation’s ability to regulate the industry at arm’s length.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the regulatory environment and the ABPI, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
UK - Eisai Opens European Headquarters in UK
Eisai opened its European headquarters in Hatfield, UK in June 2009. The ‘European Knowledge Centre’ is made up of a manufacturing plant, research laboratory, office building and other shared facilities and will employ a total of 500 staff, including 250 newly created research positions. The company has invested around £100 million in the project.
Japan-based Eisai manufactures pharmaceuticals for conditions such as Alzheimer’s disease, Parkinson’s disease and epilepsy.
Eisai’s European regional headquarters, manufacturing subsidiary, and UK clinical research and sales subsidiary have all relocated to the new centre, and a new research centre has been added to strengthen the company’s research subsidiary at University College London.
The facility will enable the company to manufacture its own products in Europe for the first time, as previously it has relied on business alliance partner companies. Eisai will start packaging several of its products in-house by the end of the fiscal year 2009, and plans to manufacture drug formulations in the future.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on domestic production and multinational manufacturers, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
Japan-based Eisai manufactures pharmaceuticals for conditions such as Alzheimer’s disease, Parkinson’s disease and epilepsy.
Eisai’s European regional headquarters, manufacturing subsidiary, and UK clinical research and sales subsidiary have all relocated to the new centre, and a new research centre has been added to strengthen the company’s research subsidiary at University College London.
The facility will enable the company to manufacture its own products in Europe for the first time, as previously it has relied on business alliance partner companies. Eisai will start packaging several of its products in-house by the end of the fiscal year 2009, and plans to manufacture drug formulations in the future.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on domestic production and multinational manufacturers, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
UK - NICE Stands by Guidance on Anti-Cholinesterase Drugs
The National Institute for Health and Clinical Excellence (NICE) released guidance on anti-cholinesterase drugs in June 2009, recommending them for NHS patients with moderate Alzheimer’s disease only.
This is the same conclusion the watchdog reached in 2005, but NICE admitted that there had been errors in the initial economic model used to determine the cost-effectiveness of the drugs.
The guidance applies to Aricept (donezepil), marketed by Eisai and Pfizer, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine).
Eisai and Pfizer fought the original decision, arguing that the treatment should also be available to patients with mild Alzheimer’s disease. However, they will not appeal the latest guidance.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information about NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
This is the same conclusion the watchdog reached in 2005, but NICE admitted that there had been errors in the initial economic model used to determine the cost-effectiveness of the drugs.
The guidance applies to Aricept (donezepil), marketed by Eisai and Pfizer, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine).
Eisai and Pfizer fought the original decision, arguing that the treatment should also be available to patients with mild Alzheimer’s disease. However, they will not appeal the latest guidance.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information about NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
UK - Brown Promises New Rights for NHS Patients
Prime Minister Gordon Brown promised new rights for NHS patients in June 2009, under the draft legislative programme, Building Britain’s Future, which includes many other public reforms.
In a statement to the Commons, Mr Brown pledged that NHS patients would have “enforceable rights to high standards of care” including hospital treatment within 18 weeks, access to a cancer specialist within two weeks, and free health checks on the NHS for people aged 40-74. Mr Brown also said they would look into the possibility of new rights regarding NHS dentistry, extended access to GPs, individual health budgets for patients with long-term illnesses and the right to choose to die at home.
Mr Brown also pledged that Health Secretary Andy Burnham would bring forward proposals to strengthen the NHS’ focus on disease prevention and early intervention, to extend patient choice, and to reform early years and maternity services.
In addition, Mr Brown said ministers would consult on “far-reaching proposals for how we need to modernise our health and social care systems so that our country can meet the challenge of an ageing society”.
However, the British Medical Association claims the changes will have little impact, with the “vast majority” of patients referred to a cancer specialist already seeing one within two weeks and claiming that “further improvements will depend on an expansion in numbers of consultants”.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the healthcare system and health policies, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
In a statement to the Commons, Mr Brown pledged that NHS patients would have “enforceable rights to high standards of care” including hospital treatment within 18 weeks, access to a cancer specialist within two weeks, and free health checks on the NHS for people aged 40-74. Mr Brown also said they would look into the possibility of new rights regarding NHS dentistry, extended access to GPs, individual health budgets for patients with long-term illnesses and the right to choose to die at home.
Mr Brown also pledged that Health Secretary Andy Burnham would bring forward proposals to strengthen the NHS’ focus on disease prevention and early intervention, to extend patient choice, and to reform early years and maternity services.
In addition, Mr Brown said ministers would consult on “far-reaching proposals for how we need to modernise our health and social care systems so that our country can meet the challenge of an ageing society”.
However, the British Medical Association claims the changes will have little impact, with the “vast majority” of patients referred to a cancer specialist already seeing one within two weeks and claiming that “further improvements will depend on an expansion in numbers of consultants”.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the healthcare system and health policies, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
UK - Cervical Cancer Screening Age Will Not Be Lowered
The Department of Health will not lower the age for cervical cancer screening, following a review by the independent Advisory Committee on Cervical Screening (ACCS) in June 2009. The ACCS cited evidence that shows earlier screening can lead to more harm than good, with too many false positives and an increase in the risk of premature births in some women.
However, at the British Medical Association’s annual conference on 2nd July 2009, doctors voted three to one that women should be screened from the age of 20.
Cervical cancer screening takes place from the age of 20 in Scotland, Wales and Northern Ireland, but was raised to 25 in England in 2003.
It was also noted that the number of women attending smear tests has fallen by 10 per cent over the past 10 years, and the poorest attendees - around 72 per cent - are those in the younger age group.
However, part of the review by the ACCS also recommended expanding work to increase screening uptake in women aged 25 to 34.
Further reading - An in-depth analysis of the UK Pharmaceutical Market, including some background information on health policies and cancer statistics, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
However, at the British Medical Association’s annual conference on 2nd July 2009, doctors voted three to one that women should be screened from the age of 20.
Cervical cancer screening takes place from the age of 20 in Scotland, Wales and Northern Ireland, but was raised to 25 in England in 2003.
It was also noted that the number of women attending smear tests has fallen by 10 per cent over the past 10 years, and the poorest attendees - around 72 per cent - are those in the younger age group.
However, part of the review by the ACCS also recommended expanding work to increase screening uptake in women aged 25 to 34.
Further reading - An in-depth analysis of the UK Pharmaceutical Market, including some background information on health policies and cancer statistics, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
UK - Elderly Cancer Deaths on the Rise
Around 15,000 cancer patients aged 75 years and over may be dying unnecessarily every year in the UK, according to research from the North West Cancer Intelligence Unit. The findings show that the number of under-75 year olds dying from cancer has fallen, but that little progress has been made in the over 75 years category. Every year 75,000 people aged over 75 years die of cancer.
The researchers blamed the findings on delays in diagnosis and poor treatment. According to the lead researcher, Dr Tony Moran, elderly cancer patients are not benefiting from cancer care improvements made in the past 10 years. He stated that if the UK was performing as well as Western Europe in the 75-84 year olds age group, and as well as the US in the over 85 year old group, there would be 15,000 fewer cancer deaths in the elderly each year.
The study also showed that UK cancer deaths in people aged over 85 years increased by two per cent in eight years, while in Europe they fell by 16 per cent.
Further reading - An in-depth analysis of the UK Pharmaceutical Market, including some background information on UK cancer statistics, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
The researchers blamed the findings on delays in diagnosis and poor treatment. According to the lead researcher, Dr Tony Moran, elderly cancer patients are not benefiting from cancer care improvements made in the past 10 years. He stated that if the UK was performing as well as Western Europe in the 75-84 year olds age group, and as well as the US in the over 85 year old group, there would be 15,000 fewer cancer deaths in the elderly each year.
The study also showed that UK cancer deaths in people aged over 85 years increased by two per cent in eight years, while in Europe they fell by 16 per cent.
Further reading - An in-depth analysis of the UK Pharmaceutical Market, including some background information on UK cancer statistics, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
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