BioWorld International Correspondent

LONDON - Biogen Idec Inc., has forced a change of heart from the UK's health economics watchdog, persuading it that Tysabri represents good value for the money in treating highly active relapsing remitting multiple sclerosis (MS).

The National Institute for Health and Clinical Excellence (NICE) had ruled previously that on cost and efficacy grounds the drug should not be reimbursed. After a vigorous campaign by the company, supported by patients' groups, NICE on Tuesday published its final appraisal determination, overturning the earlier decision and saying the use of the drug, "would be a cost-effective use of National Health Service resources."

It is estimated by Biogen that there are 2,500 people in the UK who will benefit as a result, at a cost of £14,750 (US$29,705) per patient per year. The drug received UK marketing approval in June 2006.

The data presented by Cambridge, Mass.-based Biogen drew on work by Heron Evidence Development Ltd. of Letchworth, UK, a health technology assessment consultancy. Heron spent 2.5 years on a review that identified potential gaps in the available evidence-base, following that up with what it claims was the largest survey of medical resource and quality of life of people with MS ever conducted in the UK, to fill the gaps.

In addition, the pivotal Phase III trial, AFFIRM, was reanalyzed to demonstrate the rapid rate of disability progression in people with highly active relapsing remitting MS compared to the relapsing remitting form. Heron developed a new cost-benefit analysis of Tysabri compared with current licensed products, beta interferon and glatiramer acetate, in people with highly active disease.

That prompted NICE to acknowledge the value of Tysabri in highly active relapsing remitting MS, though it maintained its stance that there is not sufficient clinical data to prove the drug is effective in treating those with the relapsing remitting form of the disease who have not responded to treatment with beta interferon.

John Kerrigan, managing director of Heron, said the project had challenged conventional wisdom. "We had to overcome existing perceptions about the role of disease modifying treatments in MS and apply a broad range of health technology assessment skills to analyze the issues."

The UK patient group, the Multiple Sclerosis Society, had argued that given the lack of alternatives, Tysabri offers a breakthrough in the treatment of the highly active, aggressive, relapsing forms of MS. Welcoming NICE's new recommendation, the society's chief executive, Simon Gillespie, said the drug represents a vital treatment option. "NICE's decision highlights the need for new treatments for MS and for a rational approach to prescribing," he said.