PHP79 - LESS HASTE, MORE SPEED? DO EUROPEAN ACCELERATED AUTHORISATIONS TRANSLATE INTO EARLY REIMBURSEMENT AND PATIENT ACCESS?

Abstract

Medicines of a major interest for public health can qualify for an Accelerated Assessment (AA) by the European Medicines Agency (EMA), reducing the centralised assessment timeframe from 210 days to 150 days. In 2016, the AA procedural framework was optimised and the PRIority MEdicines (PRIME) scheme was introduced to facilitate greater utilisation of the AA process. However, to reach patients, medicines must also be publically reimbursed. This research aims to assess the reimbursement outcomes of major public payer bodies for all medicines approved under AAs. Medicines approved under AAs and their appraisals by major European payer bodies (NICE, SMC, G-BA, and HAS) were identified from the relevant websites and key data extracted (up to 31/12/2017). 32 medicines have received AAs since 2012, with no clear trend over time (5.3/year; range: 1–7) after an average of 215 days post-submission (range: 178–329, including clock-stops). 31% (10/32) were for oncology indications and 50% (16/32) were orphan drugs. 86% (18/21) of medicines with AAs that were assessed by NICE received positive outcomes (defined as “recommended” or “conditional”), compared with 90% (19/21) by SMC (defined as “accepted” or “restricted”), 68% (17/25) by G-BA (defined as any level of additional benefit), and 88% (21/24) by HAS (defined as ASMR I-III). The median delay between marketing authorisation under AAs and positive HTA outcome were 7.4 months (G-BA), 7.9 months (HAS), 11.7 months (SMC), and 11.8 months (NICE). AAs provided market authorisations at least two months earlier than standard. Although high rates of positive payer outcomes are achieved, these products typically experience additional delays in securing public reimbursement that can exceed 12 months. Thus, AAs alone will not secure expedited patient access and commercial returns unless supported by robust payer evidence generation and communication strategies to translate AAs into optimal reimbursement.