NICE And Its Decision Not To Approve Rheumatoid Arthritis Drug Abatacept, UK

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 May 2008 - 0:00 PDT

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The failure of the UK National Institute for Clinical Excellence (NICE) to approve treatment of the rheumatoid arthritis (RA) drug abatacept on the National Health Service (NHS) is discussed in the lead Editorial in this week's Lancet. Abatacept, is, with rituximab and tocilizumab, one of three new drug classes that have shown clinically significant improvement for the treatment for RA.

One of the criteria NICE use to assess any new drug prior to approval is its incremental cost-effectiveness ratio (ICER), with a limit set at £30 000 per quality-adjusted life-year gained. The ICER of abatacept was estimated at £37 000-£43 000 , possibly higher - yet the Editorial says many of these estimates are no more than best guesses based on insufficient or incomplete evidence. But after various organisations, including abatacept's manufacturer Bristol-Myers Squibb and the British Society for Rheumatology, appealed, the NICE appeal committee ruled that "Abatacept would not be a cost-effective use of NHS resources for patients in whom rituximab failed or in whom rituximab is contraindicated."

The Editorial acknowledges that The Lancet has long been a supporter of NICE, calling its procedures "rigorous, scientifically driven, and publicly accountable." But it concludes: "Any new and effective treatment for such a debilitating condition as rheumatoid arthritis should be welcomed with enthusiasm. But NICE is at the sharp end of husbanding NHS resources. It has to balance evidence with cost. And here there is a perilous conflict between its dual clinical and political purpose. There will be occasions when exceptions to strict cost-effectiveness guidelines must be made on clinical grounds. Abatacept is a strong candidate to be such an exception. Worse still, NICE's decision may unwittingly act as a disincentive to industry to develop new medicines in this neglected and poorly understood area. Although NICE will rightly say that it has followed the letter of its cost-effectiveness law, patients and the public may, with justification, feel that it has forgotten the spirit of those same laws - namely, that cost-effectiveness evidence needs to be interpreted with compassion as well as impartial science."

"NICE and new drugs for rheumatoid arthritis"
The Lancet - page 1477, Volume 371, Number 9623, 3 May 2008
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