PURPOSE: From April 2016, cancer drugs that appear promising in terms of cost-effectiveness, but for which the clinical evidence is not strong enough for routine commissioning, may be recommended by NICE. Such drugs will be made available through the Cancer Drugs Fund (CDF) for a limited time while more evidence is gathered. NICE has implemented a new Technology Appraisal process and methods for the new CDF. This workshop will provide an overview of the new CDF operating model, guidance on how manufacturers can best prepare for NICE’s appraisal for a cancer drug when a conditional recommendation for use within the CDF is anticipated, and an extended Q&A session to answer audience questions about the new process.
DESCRIPTION: This session will start with an introduction to changes to the Technology Appraisal process to take account of the CDF. The circumstances under which NICE may issue a recommendation for use within the CDF will be described. We then will discuss how manufacturers can best prepare for appraisal if a recommendation for use within the CDF seems likely. Topics covered will address any differences in the content of the manufacturer’s evidence submission; approach to evaluating whether (given uncertainty in the clinical data) the ICER has the “plausible potential” to lie within the range normally considered a cost-effective use of NHS resources; and the assessment and implications of end-of-life criteria. Consideration also will be given to the kind of study or data collection that could be feasible within the limited time period, the review of the guidance after data collection, and the commercial access arrangements under the new CDF. The workshop will include an extended interactive Q&A session, during which the audience will have the opportunity to discuss aspects of the CDF with the panel.
