HEDS is part of the School of Health and Related Research (ScHARR) at the University of Sheffield. We undertake research, teaching, training and consultancy on all aspects of health related decision science, with a particular emphasis on health economics, HTA and evidence synthesis.

Thursday, 26 July 2012

NICE to take over orphan drug assessment

This 'announcement' was made in the House of Lords on the 18th July.  Being the second chamber of parliament, it didn’t get much coverage.  The text is reproduced below:

“I mentioned one important aspect of the work of AGNSS, in assessing very high-cost, low-volume drugs, but so far I have not explained where this function will sit in the new system. We have looked at several potential options. I am pleased to announce that, on the basis of a detailed proposal and discussions, we have asked NICE to take on the assessment of very high-cost, low-volume drugs from April 2013. I am aware that some noble Lords may have concerns about NICE taking over this work, as the current cost per quality-adjusted life year that NICE operates for its appraisals of drugs would rule out highly expensive drugs for small numbers of people with rare conditions. We have explored this issue thoroughly with NICE and it has developed a process for assessing such drugs. It will build on the decision-making framework that AGNSS uses at the moment. That framework balances health gain, best clinical practice, societal value and reasonable cost. In addition, recommendations from NICE will not be based solely on a cost per QALY figure.

NICE proposes setting up a dedicated expert panel to produce an assessment of a new drug, usually within six months. Given that we wish the new process to commence in April 2013, NICE will develop interim methods for the first few assessments. The institute plans to subject these processes and methods to a consultation in 2013-14 alongside the assessments it will carry out. NICE's work will make sure that we have a robust, transparent and consistent process in place for assessing very high-cost, low-volume drugs. We have a number of points of detail that Department of Health officials are still exploring with the institute. I will be able to say more about the detail of this proposal in the coming weeks, but, in the mean time, I thought it important to provide a progress report to the House.”