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)

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:

• 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.

The appraisals where observed use was lower than the predicted use in 2008 are:

• 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.

In one case, the use of the drug was lower than predicted in 2008 but its use is rising and it is likely to exceed the expected level in 2009.

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)

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)

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)

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)

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 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)

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)

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)

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:

• 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 - 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)

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)

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)

UK - Innovative Medicines will Reach Patients Faster

Patients will have faster access to innovative medicines, under new proposals announced by the Office for Life Sciences on 14th July 2009.

The measures outlined in the ‘Life Sciences Blueprint’ include:

• The introduction of an Innovation Pass, administered by NICE, which will allow time-limited use of selected innovative medicines on the NHS. The selected medicines will be those which can deliver improved patient outcomes to a small number of patients, but where a lack of cost-effectiveness data is limiting market access. Therefore, they will be funded without going through a NICE appraisal. However, NICE will develop and apply eligibility criteria for the Pass, giving patients with the greatest need earlier access to innovative drugs. The medicines will be evaluated by NICE after the three-year initiative comes to an end. The Pass will be piloted in 2010/11, with a budget of £25 million from the Department of Health.
• The NHS Chief Executive will review system levers and incentives, including Payment by Results, to accelerate the uptake of new medical technologies.
• The Government will reinforce the need for greater emphasis on research and clinical trials in the next NHS Operating Framework.
• The Government will support the formation of a UK Life Sciences Super Cluster to co-ordinate work across industry, higher education and the NHS, and to boost international recognition of UK life sciences.
• The blueprint calls for the Treasury to further investigate the possibility of a ‘patent box’ tax incentive, offering a lower rate of tax on profits derived from patents located in the UK to encourage the creation and exploitation of intellectual property in the UK.
• The Technology Strategy Board will launch an £18 million ‘RegenMed’ programme of investment to support commercial R&D and the development of NHS partnerships, supported by an additional funding of £3.5 million from Research Councils.
• The Government will invest an extra £1 million to promote the UK and NHS brands at flagship life sciences events in the UK and overseas.

The Office for Life Sciences was created on 27th January 2009 and has since been working on this package of measures to transform the operating environment for life science companies in the UK. The next step will be to develop detailed delivery plans for each action, which will be published in the autumn.

Further reading - A detailed review of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)

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)

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)

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)