Drugmakers seeking to appeal negative recommendations made by the National Institute of Health and Clinical Excellence could soon find more sympathetic panelists hearing their pleas as the UK’s Department of Health gains power over appeals board appointments.
Proposed legislation would give British Health Secretary Andrew Lansley power to approve appointments to appeals panels, reports PMLive. Under the new rules, appeals panel chairs would need to be independent, rather than non-executive directors of NICE, as they currently are.
Industry has long disdained NICE’s power to cast even approved drugs in a negative light. The agency in June said it could not recommend Roche’s recently approved melanoma drug, Zelboraf, as a cost-effective treatment for skin cancer. And in April, the agency told GlaxoSmithKline that it believed the company’s lupus drug, Benlysta, is too costly.
Association of British Pharmaceutical Industry chief executive Stephen Whitehead, writing to Lansley in June, expressed concern that “the ongoing influence of some of the current negative decisions made by NICE in boardrooms is creating a negative view of the UK, which will do nothing to support growth and investment.”
Whitehead criticized NICE policy as being made “a long way from political accountability,” and said that NICE Chief Executive Andrew Dillon appears to have no “desire to challenge the decisions of independent academics.”
But while NICE is often regarded as thorn in the side of industry, the agency is making reforms to be more responsive to concerns regarding its power to make or break the success of new therapeutics in the United Kingdom. In June, it announced plans to meet with groups and investors that fund early-stage drug research to discuss what data companies need to generate to demonstrate value and increase the likelihood of their products being purchased by the National Health Service.
August 24, 2012
http://www.burrillreport.com/article-nice_appeals_process_overhaul_in_the_works.html