Monday August 21 1:24 PM ET
By Richard Woodman
LONDON (Reuters Health) - The National Institute for Clinical Excellence (NICE), a UK pharmaceutical watchdog, has confirmed its preliminary assessment that there is insufficient evidence to justify the general use of beta interferon for patients with multiple sclerosis, sources told Reuters Health on Monday.
They said that an appeal would now be lodged by the Multiple Sclerosis Society, which represents sufferers, and almost certainly also by the three manufacturers Schering, Biogen and Serono.
Officially, none of the stakeholders involved in the process can comment because they have all signed confidentiality agreements. However one person closely involved said: "You can assume there is going to be an appeal."
He said that nothing substantial had changed between NICE's preliminary negative assessment--which was leaked in July--and its final assessment, which was received in confidence by stakeholders nearly ten days ago.
The deadline for lodging an appeal is tomorrow and the outcome will not be known before the end of September.
Another source said it would be wrong to necessarily interpret news of an appeal in a completely negative light. She said the argument could be over what scale of disability would make use of the drug worthwhile rather than a total ban on the drug.
Going to appeal was a "tough call" because it would delay the final decision--and possible treatment for some patients--for at least another month, she said.
The companies estimate that around half of the 85,000 people with MS in the UK have a clinical need for one of the beta interferon drugs whereas only 2% are actually being prescribed them.
They point out that funding policies are formulated locally, resulting in so-called post-code prescribing, where treatment depends on where patients live rather than clinical need.
The controversy over MS drugs was fueled recently by Professor Alan Maynard, health economist at York University who accused the Multiple Sclerosis Society of being too close to the pharmaceutical companies.
Writing in Pharmaceutical Times, he said the society should demand a reduction in the high price of beta interferons in Britain rather than spending all its time criticising NICE--charges strongly denied by the society.
Meanwhile, a Biogen-funded study published in the journal PharmacoEconomics last month claimed that all previous studies of cost effectiveness had made the mistake of assuming that the benefits of treatment are not maintained long-term.
By changing this assumption, the authors said that the cost of treatment came down to between 27,000 pounds ($40,220)and 38,000 pounds ($56,600) per quality-adjusted life year. If societal costs were taken into account, treatment resulted in long-term savings.
MS is a chronic, progressive disease in which the body loses patches
of myelin (the protective covering of nerve cells), which acts as a protective
covering on nerves, including those in the brain and spinal cord. Although
the cause is unknown, MS is thought to be an autoimmune disease where the
immune system begins to treat myelin as a foreign invader, attacking and
eventually destroying it. This destruction leads to scarring and damage
to the underlying nerves, causing symptoms that range from numbness and
tingling to blurred vision and paralysis.