TIME TO REIMBURSEMENT FOR ONCOLOGY DRUGS IN EU5
Author(s)
Prada M1, Berard I2, Walzer S3, Darba J4, Greenwood B5
1Intexo, Roma, Italy, 2NEXTEP, PARIS, France, 3MArS - Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 4Universitat de Barcelona, Barcelona, Spain, 5Decideum, London, W8 7JB, UK
OBJECTIVES: The study aims to compare the time elapsed between the European Marketing Authorization (MA) and the national reimbursement in EU5 for oncology drugs, approved by the EMA’s CHMP between January 2015 and December 2016. METHODS: The drugs’ panel was built by checking the CHMP approval date on the EMA website. The related dates of reimbursement were collected via the official websites of the considered National Health Authorities (Agenzia Italiana del Farmaco - AIFA, Haute Autorité de Santé - HAS, Gemeinsamer Bundesausschuss – G-BA, Medicines and Health Products Regulatory Agency – MHRA and Sistema National de Salud – SNS). For each country, the difference between the time of EMA MA and the individual national reimbursement (mean and median) has been evaluated. RESULTS: Out of a panel of 26 oncology drugs, the mean time for national reimbursement is different among the EU5, ranging from zero days in Germany (remark: each manufacturer decides on the launch date and hence reimbursement date after the EMA MA) to 442 days on average (median 422) in Italy; in the middle France (mean 302; median 212), Spain (mean 310; median 320) and the UK (mean 327; median 321). Even within each single country, the ranges between min and max time for reimbursement (days) are highly different: 119-777 Italy; 14-553 Spain; 65-668 UK, 117-719 France and 12-756 Germany (considering “real life” time to patient access post EMA approval). The overall percentage of reimbursed drugs ranges from 42% in Spain to 100% in Germany, passing through a 73% in Italy, a 62% in UK and a 77% in France. CONCLUSIONS: The study shows a considerable heterogeneity for time from EMA approval to patient access in the EU5 countries. Potential reasons might be the preferences of individual populations, different assessment criteria and processes and political rationales. Further research is required.
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
PCN225
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Oncology