PCN374 BETTER LATE THAN NEVER: THE DYNAMICS OF NICE DECISION-MAKING UNDER THE NEW MODEL OF THE CDF

Abstract

In 2016, the Cancer Drugs Fund (CDF) became a temporary reimbursement fund collecting observational data for subsequent National Institute for Health and Care Excellence (NICE) appraisals. The new appraisal guidance stipulated that data collection within the CDF should be as short as possible: normally up to two years but potentially longer depending on the issues of uncertainty. This research evaluates how this stipulation has been implemented. Publicly-available Managed Access Agreements (MAAs) entered into between NHS England and manufacturers within the CDF as of 31/05/19 were identified and key data extracted. 29 drugs were identified that were recommended for use within the CDF. The maximum data collection timeframe ranged from 5-months up to 62-months. The majority (15/29 [54%]) were issued with data collection periods greater than two years. Two drugs have subsequently been reassessed and both are now available through routine commissioning (Pembrolizumab:NSCLC, Brentuximab vedotin:Hodgkin lymphoma). Although maximum data collection periods of 6-months (Pembrolizumab:NSCLC) and 5-months (Brentuximab vedotin:Hodgkin lymphoma) were stipulated upon recommendation for use within the CDF, NICE delayed publishing technology appraisal guidance until 14-months and 13-months, respectively. Another two drugs still in the CDF (Osimertinib:NSCLC, Pembrolizumab:UC) have also exceeded the pre-specified timeframe for CDF data collection. Analysis of how the new guidance for exiting the CDF has translated into practice indicates a degree of flexibility; as the majority of drugs have been given data collection periods over two years and as of May 2019, four drugs have exceeded their prespecified data collection window. As such, NHS England are seemingly adopting an event-driven approach; open to prolonging MAAs until sufficient data are collected to address key clinical uncertainties. As a number of drugs are due to exit the scheme imminently, future research can identify whether this emerging trend continues and indeed whether this is a sustainable model going forward.