The National Institute for Health and Clinical Excellence is overhauling its appeals process. Amid criticism from the industry, including the U.K. trade group ABPI, the cost-effectiveness watchdog will add independent, non-agency members to its appeals panels.Those panels will no longer be chaired by agency types, but by outsiders.
"Industry has been calling for a more independent appeals process for many years and we think it will help deliver a more balanced system for the appraisal of medicines," ABPI chief Stephen Whitehead said (as quoted by InPharm).
As the gatekeeper for the U.K.'s National Health Service formulary, NICE determines which drugs and other treatments will be covered. The agency's decisions are closely watched not only by U.K. industry and patients, but by government payers in other countries. So, NICE's acceptance--or rejection--can have a ripple effect into other markets.
And the watchdog's decisions are often controversial. The agency has looked askance at expensive cancer treatments, drawing fire for its early rejections of the Bristol-Myers Squibb ($BMY) melanoma treatment Yervoy and Roche's ($RHHBY) targeted melanoma drug Zelboraf, to name two. It has also rejected pricey new drugs for chronic illnesses such as lupus--GlaxoSmithKline's ($GSK) Benlysta--and multiple sclerosis--Novartis' ($NVS) Gilenya, which eventually won a recommendation.
Sometimes those rejections persuade drugmakers to reduce the cost side of the equation, however; Johnson & Johnson's ($JNJ) new Zytiga pill for prostate cancer got an initial thumbs-down, but a discount plan persuaded NICE to change its mind. Other times, even discount offers don't work--and drugmakers appeal the agency's decision.
And that's where the appeals board comes in. ABPI has been complaining about the appeals board's use of "independent academics" and agency folk. "Policy is made a long way from political accountability," ABPI wrote to the U.K. health secretary earlier this summer, adding: "The burden of proof is currently absolutely on industry and academic purity can override pragmatism."
Now, the panel chair and most of its members will be appointed from outside NICE, a health department spokesperson told Pulse. And appointments have to be confirmed by the secretary of state, rather than being up to NICE's discretion.
- see the Pulse piece
- get more from InPharm
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