More MS news articles for Nov 2001

The issue explained: beta interferon

Why has the drug beta interferon, used in the treatment of multiple sclerosis, proved so controversial?,7890,395341,00.html

Patrick Butler

What is beta interferon?

Beta interferon is a drug used to reduce the frequency and severity of relapses afflicting people suffering from multiple sclerosis (MS). MS is a neurological disorder affecting the brain and spinal cord, which over time can lead to poor coordination and severe disabilities. It affects around 85,000 people in the UK. Relapses vary but are basically painful and distressing episodes that can result, in extreme cases, in blindness, paralysis, incontinence and hospitalisation.

Does it work?

Beta interferon is not a cure for MS, nor does it work for all MS sufferers. Its supporters claim that it reduces the number of relapses by one third on average, and that some people who take the drug stop relapsing completely. They say that people taking beta interferon require less hospital treatment, and thus save the NHS money. Opponents of the drug claim that it is costly but not cost-effective; while it is effective in the early phase of the disease, it has no long term effect on the progress of the disability. They claim there is no evidence that at the end of five years those who take the drug will be any less disabled than MS sufferers not using beta interferon.

Why is it so controversial?

The view of the national institute for clinical excellence (Nice), expressed in a preliminary ruling in August 2001 that beta interferon should not be available on the NHS, has become a symbol of the wider debate on NHS rationing. The drug is also at the heart of controversies over unequal access to healthcare. The so-called "postcode lottery" means that at present the chances of being treated with beta interferon vary widely, and randomly, between health authorities; where you live, and the policy of the individual hospital to which you are referred, defines whether you will have access to the drug or not. Nice believes that its final ruling, which will apply to all English and Welsh health authorities, will effectively abolish the NHS postcode lottery in beta interferon.

What is Nice?

Nice was set up in 1999. Consisting of senior doctors, managers and academics, its role is to produce "authoritative, robust and reliable guidance" on which drugs and medical procedures should be available on the NHS in England and Wales, by analysing their clinical and cost effectiveness. It also aims to help define minimum universal standards of NHS care. Technically, its decisions are in the form of guidelines to the NHS. Ministers can in theory order the NHS to ignore the guidance, although this would be difficult in practice to do.

Why has Nice ruled out beta interferon on the NHS?

Nice gave a "provisional view" in July 2000, just under a year of being asked to appraise beta interferon, that the drug should not be made available on the NHS, except to those already taking the medication, because its "modest clinical benefit appears to be outweighed by (its) very high cost". In other words, Nice argued that the money spent on beta interferon (around £10,000 a year for each patient) would be better spent on other forms of treatment for MS, such as physiotherapy. MS charities and pharmaceutical companies appealed. The MS Society and various pharmaceutical companies appealed against this preliminary ruling, forcing Nice in November 2000 to re-assess its costing methodology. Having done this, Nice delivered a second preliminary ruling in August 2001, largely repeating its original conclusions, while urging the DoH to examine ways of securing the drug for the NHS in "a manner which could be considered to be cost-effective". Its formal ruling, in the form of guidance to the NHS, known as a Final Appraisal Determination, is expected on November 2 2001.

Does this mean that the drug will not be available to any MS sufferers?

No. It will be available on the NHS to those already on a course of the drug, and it will be available to anyone who wants to pay privately for treatment. However, it will not generally be available on the NHS unless the government manages to sidestep the Nice guidance by arranging a side deal with the pharmaceutical companies to supply the drug to health service patients at discounted rates. If no deal can be done, it is likely that the MS society and the pharmaceutical industry will seek a judicial review of the Nice decision.

If it's not cost effective, why are ministers so keen to allow beta interferon on the NHS?
It gets ministers off the hook of the potentially damaging accusation that they are actively "rationing" vital treatment on the NHS, despite the fact that barring costly and inneffective treatments was precisely what Nice was set up to do. Beta interferon has become something of a cause celebre in this respect. Doing a side deal may also appease the pharmaceutical industry, and head off an equally damaging legal challenge, which, if it went against the Department of Health, could lead to a rush of future legal challenges and effectively scupper any future attempts to regulate the provision of costly drugs on the NHS. © Guardian Newspapers Limited 2001