More MS news articles for Dec 2001

Funding medicines for people with multiple sclerosis

Providing outcome guarantees may help fund innovative treatment

http://bmj.com/cgi/content/full/323/7326/1379?view=full&pmid=11744549

15 December, 2001
BMJ 2001;323:1379-1380
David Taylor, professor of pharmaceutical and public health policy.
School of Pharmacy, University of London, London WC1N 1AX

The establishment of the National Institute for Clinical Excellence (NICE) in 1999 was one of the cornerstones of New Labour's strategy for improving the NHS. Its mission includes giving guidance on how medicines should be prescribed to provide affordable value for money. This should eliminate postcode rationing, whereby some NHS patients are given expensive drugs depending on where they live, while people with similar needs elsewhere are denied the same treatment.

Recommendations from NICE have often levelled up access to pharmaceutical care. But a recent decision by NICE not to support the use of interferon beta in multiple sclerosis has become a focus of critical attention. Patient support groups and pharmaceutical companies argue that this will undesirably lower standards of NHS care. There are also concerns among pharmaceutical companies that where Britain leads in restricting access to new drugs others may follow. The waters have also been muddied by news that Britain's Department of Health is negotiating with manufacturers of interferon beta to find a way of funding the drug for patients with multiple sclerosis on a "sale or return" basis.(1)

When, last month, NICE published its "final appraisal determination" on the use of interferon beta and glatiramer acetate in multiple sclerosis,(2) the institute emphasised that it did not constitute firm guidance. Appeals from bodies such as the Multiple Sclerosis Society remain to be considered. Yet the finding that these treatments are not cost effective seems likely to stand.

The upper threshold for interventions judged to offer acceptable NHS value is presently about £30 000 per quality adjusted life year. But the price of interferons and glatiramer calculated by NICE is an order of magnitude higher over a five to 10 year time horizon. Longer usefor 20 years or moreshould prove more cost effective in preventing severe disability and saving lives. Yet NICE did not feel able to extrapolate from current data to this conclusion. Such problems are particularly challenging with new treatments for chronic illnesses.

The final appraisal determination states that people with multiple sclerosis in the NHS already receiving treatment ought not to have it withdrawn. Presently the NHS treats only 3% of people with multiple sclerosis with interferon beta or glatiramer. Equivalent rates in North America and richer European Union nations are around 20%.

However, days before the final appraisal determination appeared there were press reports of a new deal being negotiated by the Department of Health.1 These suggested that every person with multiple sclerosis who might benefit from treatment could have it on a no gain no cost basis. The details have not yet been agreed but it could involve the NHS receiving a discount based on the proportion of treatment provided to patients whose illness fails to respond. The government's likely goal is to bring down the cost per quality adjusted life year gained to below £30,000.

Notwithstanding the ethics of spin doctoring, news of this initiative was well received. Some commentators speculated that such a risk sharing approach might expose data "which some health service officials believe companies already hold" showing in which patients interferon beta and glatiramer work most effectively.(3) Such accusations lack credibility, because of the limited global uptake of such treatments (more precise indications might increase prescribing) and the implications they carry for the integrity of the entire medical research community. Nevertheless, the concept of sharing the cost and risks of drugs between the health service and private companies deserves serious attention.

Providing outcome guarantees could create new ways of funding innovative treatment programmes and meeting public expectations. Yet in Britain such purchasing arrangements may raise questions about the future of the pharmaceutical price regulation schemewhich governs drug prices in the NHS and is designed to limit the UK returns of companiesand the locally based pharmaceutical industry. For example, will the proposed new deal prove to be merely a covert way of cutting the prices of drugs or a desirable path towards sharing through public and private partnership the cost of identifying which patients benefit from treatment? And what interests do people in economically developed countries such as Britain have in supporting markets for medicines for conditions like neurological diseases, which will over time become increasingly responsive to treatment with drugs?

Public debate about providing products such as interferon beta has highlighted the fact that applying the cost utility method used by NICE will occasionally involve making explicit unpopular rationing decisions. Critics of quality adjusted life years and NICE argue that full account has not been taken of the political and social consequences of refusing to provide effective treatments (4) to patients with life threatening diseases.

Other observers fear that a risk sharing approach will force company earnings below the levels available in a free market or under the pharmaceutical price regulation scheme. Britain's position as a world centre for pharmaceutical research and enterprise might decline as a result.(5) But seen positively, the strategy presently being developed by the Department of Health and companies producing treatments for multiple sclerosis could prove beneficial. An appropriately framed strategy should help resolve uncertainties about cutting edge treatments where the ultimate impact of costly drugs on health outcomes is not known throughout most of the life of their patents, or of the patients taking them.

Allowing the use of such drugs within negotiated long term cost and benefit boundaries ought to provide protection from the unwanted side effects that a rigidly evidence based but not necessarily humane approach might impose. Some of the individuals and families affected by multiple sclerosis have felt abandoned while British politicians, industrialists, and bureaucrats argue about money. For them, the prospect of secure access to treatments that work will in itself provide welcome relief.

References

1.  Mayor S. Health department to fund interferon beta despite institute's ruling. BMJ 2001; 323: 1087[Full Text].
2.  NICE. Final appraisal determination: beta interferon and glatiramer for multiple sclerosis. Nice.org.uk/pdf/betainterferonfad.pdf [accessed 30 October 2001]
3.  Timmins N. Need for cheap MS treatment leaves Milburn in a quandary. Financial Times 2001;1 Nov.
4.  Goodin DS. Interferon beta therapy in multiple sclerosis. Drugs 2001; 61: 1693-1703[Medline].
5.  Dyer G. US beating Europe drug sector, says Pfizer. Financial Times 2001;6 Nov.
 

© BMJ 2001