NICE asks for more data on MS drug

NICE says it is minded to not recommend Biogen Idec’s MS treatment Tecfidera, but has asked the pharma company to clarify some questions before it issues its final decision.

Tecfidera (dimethyl fumarate) is a new twice-daily oral treatment for adults with relapsing-remitting multiple sclerosis, which many market analysts have predicted will become a market leader among a new wave of oral treatments for the disease.

Phase III trial results for the drug suggest it can cut annual relapse rates by around 50% compared to placebo, and cut disability progression by more than 30 per cent.

But NICE’s appraisal committee is presently less than convinced that the data shows the drug is worth using on the NHS.

UK patient advocates say this initial decision is disappointing, but hope the cost-effectiveness watchdog will be persuaded to change its mind.

Nick Rijke, Director of Policy and Research at the MS Society, said: “This initial decision is disappointing news, but we’ve been here before for other MS treatments and seen the NICE decision overturned, so we’re hopeful to see a repeat of that. This treatment is proven to be safe and effective in treating MS and we’re appealing to NICE to make it freely available on the NHS.

Biogen Idec has until Wednesday 12 March 2014 to submit the extra information to NICE. Other stakeholders can also comment on the draft guidance, after which the committee will review the evidence and update its guidance.

Final guidance is expected to be published in the summer of 2014. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Biogen Idec has already agreed a patient access scheme with the Department of Health to lower the cost of the drug to the NHS,

Nevertheless, NICE has requested clarification about the drug’s cost and clinical effectiveness profile. This request spans a number of areas, including a new presentation on relapse rates for patients, as well as a re-modelling of Tecfidera’s costs to show how it compares to standard beta-interferon prices on the NHS.

The last few years have seen a rush of new treatments for MS, and the setback to Biogen Idec is good news for its rivals. Sanofi’s Aubagio (teriflunomide) is a once-daily oral drug for relapsing-remitting MS, and this gained NICE recommendation in December.

Another oral treatment, Novartis’ Gilenya (fingolimod), for the more severe highly active relapsing–remitting multiple sclerosis, gained approval in 2012.

Close behind Tecfidera is yet another new MS treatment, Sanofi/Genzyme’s Lemtrada (alemtuzumab). The NICE appraisal for Lemtrada is expected to be published in April.

Links

Novartis launches new multiple sclerosis online campaign

FDA rejects Genzyme’s biological drug for MS

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