Question

CASE STUDY

Providing new drugs on the NHS to people with multiple sclerosis

Multiple sclerosis is a debilitating and incurable disease. A new drug, with the generic name of beta interferon, has been shown to alleviate the effects of the disease but it costs £10,000 per patient per year. The National Institute for Clinical Excellence (NICE) in the UK investigated the drug to see whether, on clinical and economic grounds, it should be made freely available on the NHS.

The belief of those who suffer from the disease, and of those who support them through membership of lobby groups, is that it would be unfair to deny this drug to sufferers. The following article from the Financial Times identifies some of the politics and anger that surround the issue.

The National Institute for Clinical Excellence has put off a decision on the use of beta-interferon, the drug for multiple sclerosis sufferers, until at least July next year. The decision to delay has been taken to allow a publicly available economic model of the costs and benefits of the drug to be built. The delay brought a furious reaction from the Multiple Sclerosis Society that accused the institute of putting back the decision to ensure that it came after the likely date of the general election.

Peter Cardy, the society’s chief executive, described the decision to delay as ‘astonishing’ and ‘breathtaking bungling’ given that beta-interferon and glatiramer, another MS drug, have been reviewed by the institute for almost a year.

Mike Wallace, a former managing director of Schering, which manufacturers beta-interferon, said: ‘I find it appalling. You have to wonder what these guys are playing at. I feel desperately sorry for the people with MS

who have had their hopes raised and dashed and raised and dashed again by the NICE process.’

The institute initially judged that MS drugs were not cost effective and should be supplied only to patients already receiving them. Appeals led to that decision being reconsidered, but the institute is unhappy with the economic models that Schering and Biogen have supplied. The appeals committee described as ‘flawed’ a model built by Biogen that claimed the drug might save money when the cost of working days lost by patients and carers was taken into account. Schering has submitted a new model, but has told the institute that it is commercially sensitive – a stance which appraisal committee members say makes it difficult for the institute to explain its objections to the model’s conclusions.

The committee has, therefore, decided to build its own model – an approach that may force manufacturers to reveal more of the assumptions behind their results. Mr Cardy said it was ‘impossible to understand why NICE has only now decided to look at the cost effectiveness of these drugs in a different way’. He demanded that Alan Milburn, the health secretary, ‘sort NICE’s ineptitude out’.

Andrew Dillon, the institute’s chief executive, said: ‘The evidence relating to the cost effectiveness of these medicines is critically important in this appraisal.’ It was ‘of the utmost importance that the institute’s guidance is both evidence-based and seen to be fair’, and the delay to achieve that was in the best interest of those with MS. The

appraisal committee originally said that a big price reduction would be needed before the drugs became cost effective. The process of deciding what would go into the institute’s model, and the commissioning and evaluation

of its results would be transparent, said Mr Dillon. The results would be published in full, with interested parties free to comment on it.

(Source: D. Pilling and N. Timmins, Financial Times, 23 December 2000. Copyright ©

The Financial Times Limited. Reproduced with permission. Additional material from

Barlow, 2001; NICE, 2001 and 2002)

In 2002 NICE decided it would not recommend beta interferon or glatimirer for the treatment of MS.

QUESTIONS

Should the NHS approval of a new drug be based merely on clinical effectiveness or rather should it consider its cost effectiveness while realizing that the new beta interferon drug costs 1,000 pounds per year per patient who suffers from multiple sclerosis?

Is cost effectiveness criterion for the approval of a new drug a result of the focus on consequentialism or virtue approach?

Was the NHS delay to give a final decision a sign of any unethical attitudes or rather an ethical decision while considering the Multiple sclerosis patients overall rights to benefit from an available medication that has proven its efficacy in managing the complications of this chronic illness?

Answer 1

NHS approval for drug should be based on clinical effectiveness rather than cist effectiveness as government must bear healthcare costs as part if financial budget. Moreover such free approval of drugs will help millions of people fighting multiple scelorisis as common good approach bringing larger faith in government .

Cost effectiveness criteria is resulted because of consequentalism approach as more the good consequences of the product better is the Act. In this case the institute wants to focus on cost effectiveness and bring doen costs before its prices are reduced so that both institutions and peole can largely benefit and obtain good consequences

The delay in understanding cost effectiveness is completely unethical because of corporate and political agendas. The delay is largely caused for sole reason of showing political party better off at the right time when elections come in so as to get better deal of votes at cost of patient damage.