TIME FOR REIMBURSEMENT FOR ORPHAN DRUGS IN EU5 IN THE LAST THREE YEARS

Author(s)

Prada M1, Benazet F2, Berard I3, Vollmer L4, Cuesta M5, Guterres S6
1INTEXO Srl, Rome, RM, Italy, 2Nextep and MEDVANCE France, Paris, 75, France, 3Nextep and MEDVANCE France, Paris, France, 4MArS - Market Access & Pricing Strategy GmbH and MEDVANCE Germany, Tuebingen, BW, Germany, 5Oblikue Consulting, S.L., BARCELONA, Spain, 6Decideum Ltd. and MEDVANCE United Kingdom, London, UK

Presentation Documents

OBJECTIVES: In 2018 data were presented on national reimbursement decisions (days elapsed between the European MA and national reimbursement) in the EU5 countries for orphan drugs(ODs) approved by the EMA Jan2016-Sept2017 and here is the update with an extended data set. The aim of this research is to update our previous analysis and to examine whether major changes occurred. METHODS: A panel of 48 ODs was created by selecting those approved by the EMA and dates of national reimbursement was collected (sources: Agenzia Italiana del Farmaco-AIFA, Haute Autorité de Santé-HAS, Gemeinsamer Bundesausschuss–G-BA, The National Institute for Health and Care Excellence – NICE, Agencia Española de Medicamentos y Productos Sanitarios-AEMPS and Consejo General de Colegios Oficiales de Farmacéuticos-CGCOF). RESULTS: The mean difference time to reimbursement was considerably varied, ranging in Germany from immediately reimbursement available after launch; “real time launch” 91 (median 35) days to 453 (median 447) in Spain, passing through 256 (median 212) in France, 270 (median 265) in the UK and 305 (median 287) in Italy. Even within each single country the ranges between min and max time for reimbursement (days) are highly heterogeneous: 104-562 France; 67-778 Italy; 131-815 Spain; 65-568 UK; and 28-203 Germany (“real time launch” perspective). The overall percentage of reimbursed drugs ranges from 24% in Spain to 100% in Germany (41% in UK, 49% in Italy and 71% in France). By making a comparison vs 2018 data, we observed a general prolongation on time to national reimbursement for ODs in the EU5 (except from the UK); the reason is that with the extended data set and longer time frame, also “long-term” drugs are registered.CONCLUSIONS: The extended data set shows a more matured picture of the wide differences in time to reimbursement decisions, related to the heterogeneity of assessment procedures applied across Europe.

Conference/Value in Health Info

2019-11, ISPOR Europe 2019, Copenhagen, Denmark

Code

PRO74

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy, Systems & Structure

Disease

Rare and Orphan Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×