PCN259 How Accelerated Is Patients' Access to New Oncology Products in the New Era of the Cancer Drugs Fund in England, Considering the IMPACT of the 2018 New Technology Appraisal Process

Abstract

This research provides an update on a poster presented at ISPOR Europe 2018 reviewing the accelerated appraisal timetable proposed in April 2016 by National Health Service England (NHSE) and National Institute for Health and Care Excellence (NICE) to publish final guidance within 90-days of an oncology drug indication receiving its’ marketing authorisation (MA), following reforms to the Cancer Drugs Fund (CDF) in 2016. To reassess the time taken from MA to publication of final NICE guidance for new oncology Technology Appraisals (TA) against the NICE target of 90-days. Of interest is the new appraisal process (post-April 2018) which aims to streamline appraisal and regulatory timelines by introducing a ‘Technical Engagement’ step to remove issues before the Appraisal Committee Meeting (ACM). The NICE website was methodically searched to include all TAs with final guidance published before 20th May 2020 and having an ACM post 1st April 2016. Only newly licensed indications/products with MA granted by EMA before the cut-off date were included. Multiple technology appraisals (MTAs) and transition drugs which were previously in the CDF, have been excluded. Ninety-one TAs were identified across 14 cancer categories; thirteen were appraised under the new process. In total, seven (7.7%) TAs had guidance produced within 90-days of MA; two (15.4%) under post-2018 and five (6.4%) under pre-2018 process. From the 79 TAs recommending new products/indications for routine commissioning or the CDF (46 and 33 respectively), final guidance was published on average 269 days post-MA. Following MA approval, on average, patients will gain access to innovative cancer therapies within 8.4 months to improve their health outcomes. The post-2018 process has a higher proportion (54%) of final recommendations made after one ACM compared to pre-2018 process (17%). Further exploration is required to understand the barriers in meeting the 90-day post-MA target.