PCN265 CHARACTERISATION OF MANAGED ACCESS AGREEMENTS UNDER THE NICE CANCER DRUGS FUND

Abstract

In 2016, the Cancer Drugs Fund (CDF) was launched as a temporary reimbursement fund, where manufacturers could collect observational data to resolve key areas of clinical uncertainty and demonstrate that the drug works in the NHS population in England. The appraisal guidance stipulated that the time frame will be as short as possible, normally up to two years, but could be longer depending on the issues of uncertainty, the rarity of the cancer and whether the CDF data collection will be the sole source of data to address the issues of uncertainty. Publicly-available Managed Access Agreements (MAAs) currently ongoing between NHS England and manufacturers within the CDF as of 15/01/2020 were identified and key data extracted. 32 drugs were identified with active MAAs within the CDF. The primary data collection source for 84% (27/32) of drugs was ongoing clinical trials. Data collection time frames ranged from 5-months to 58-months. The majority (16/32 [50%]) were issued with data collection periods greater than two years, and the average data collection period was 28-months. As of January 2020 five drugs (osimertinib, ixazomib with lenalidomide + dexamethasone, nivolumab [SCCHN], nivolumab [SQ NSCLC], nivolumab [NSQ NSCLC] have exceeded their pre-specified data collection windows on the CDF (range: 1-22 months, mean: 8-months). Analysis of the active MAAs within the CDF suggests that the scheme is a highly attractive proposition to manufacturers. Not only are NHS England open to extending MAAs beyond the initially agreed timelines, but this research also revealed that manufacturers have been able to secure ‘temporary’ reimbursement for substantial periods of time, with some drugs expected to be on the scheme for over 4-years. In addition, most MAAs specify that more mature trial data is the primary data collection method required to address the key clinical uncertainties.