LESS HASTE, MORE SPEED? DO EUROPEAN ACCELERATED AUTHORISATIONS TRANSLATE INTO EARLY REIMBURSEMENT AND PATIENT ACCESS?
Author(s)
Macaulay R1, Wang G1, Magimaidas A2
1PAREXEL International, London, UK, 2PAREXEL International, Horsham, PA, USA
Presentation Documents
OBJECTIVES: 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. METHODS: 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). RESULTS: CONCLUSIONS: 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.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PHP79
Topic
Economic Evaluation, Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies, Decision & Deliberative Processes, Health Care Research, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Multiple Diseases
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