Pressure Grows on UK Body

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2010, Volume 0, Issue 0

Health watchdog, NICE, attracts attention.

The activities of the National Institute for Health and Clinical Excellence (NICE) are coming under close examination. Established in 1999, NICE was created as a special health authority of the National Health Service in England and Wales, and provides guidance on the promotion of good health and the prevention and treatment of ill health.

Following a series of high profile cases in which it has recommended against public funding for new therapies, two UK health experts have now strongly criticized NICE's methods for abandoning old drugs in favor of new ones. In an article in the February 25th British Medical Journal, Dyfrig Hughes, a pharmacologist at Bangor University, and Robin Ferner, Director of the West Midlands Centre for Adverse Drug Reactions at Birmingham's City Hospital, claim that NICE's decisions are often inconsistent. Its rulings may be contributing to "the postcode lottery," whereby a patient's treatment is determined largely by where he or she lives, the authors argue.

The funding of new, expensive medicines relies increasingly on releasing funds by displacing other treatments, but the authors think it sometimes makes sense to maintain an older treatment that is only marginally less effective but much cheaper than a new drug. Disinvestment is also impractical when new treatments are not substitutes for old ones but are used in addition, or in sequence. They call for an explicit framework for the identification and appraisal of medicines for disinvestment to provide better value for money while reducing inequity.

This article follows Bayer's appeal against NICE's decision not to recommend funding for Nexavar (sorafenib) in patients with advanced hepatocellular carcinoma. NICE's final ruling is likely to have a substantial effect on several hundred people who cannot afford to pay for the drug themselves.

"Since NICE's decision not to fund the drug in November, many clinicians have been put in the painful position of having to deny their patients the only survival option for them," said Professor Karol Sikora, Medical Director of CancerPartnersUK. "As we reach the end of this laborious process, which has left both patients and clinicians in limbo for far too long, we can only hope that NICE will use this final window of time to properly consider the very strong recommendations from UK oncologists."

Not so nice?

Organizations like NICE are having an increasing impact on researchers, who must take account of economic and social factors if they are going to ensure a new chemical entity will be used. NICE has also acquired an international reputation as a role model for the development of clinical guidelines, attracting attention for how it determines cost-benefit boundaries for certain technologies it assesses.

NICE International was established in 2008 to help cultivate links with foreign governments. Domestic support is not universal, however. About 16,000 cancer patients are being denied drugs they need, according to a report from the Rarer Cancers Forum (RCF) in March 15th's The Independent. The RCF says NICE should make greater efforts to agree on patient access schemes with pharma companies, and it should speed up its assessment process; UK appraisals of new cancer drugs still take an average of 21 months.

In late 2009, NICE first rejected then approved trabectedin, a new treatment for soft tissue sarcoma. The manufacturer, PharmaMar SA, had agreed to cover the costs of the drug for patients who needed it beyond five treatment cycles. According to Sir Andrew Dillon, Chief Executive of NICE, its end of life treatments protocol has already made it possible for very expensive cancer treatments, which extend life for short periods, to be recommended.

Further information is available at www.nice.org.uk—Philip Ward

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