HTA ASSESSMENT COMPARISON OF ORPHAN DRUGS IN FRANCE AND GERMANY
Author(s)
Rémuzat C1, Mzoughi O2, Rodrigues J1, Korchagina D1, Toumi M3
1Creativ-Ceutical, Paris, France, 2Creativ-Ceutical, Tunis, Tunisia, 3University Claude Bernard Lyon 1, Lyon, France
OBJECTIVES: In context of Health Technology Assessment (HTA) decision framework, some countries (e.g. Germany) have a special regulation for orphan drugs (OD), while others (e.g. France) don’t. The aim of the study was to compare the HTA decisions, prices and reimbursements for the OD that have been evaluated in France and Germany. METHODS: We selected OD assessed under AMNOG law in Germany and reviewed HTA assessments from the Transparency Committee (TC) for France and from IGWiG/G-BA for Germany, and extracted prices and reimbursement levels of these drugs in both countries. RESULTS: Eight OD were identified. In Germany, G-BA decisions related to additional benefit were non-quantifiable for 3 drugs, minor for 4 drugs, and minor in one subgroup and considerable in other subgroup for one drug. In France, one product was not assessed by the TC, and improvement in actual benefit (IAB) was rated as weak for 4 products, moderate for 2 products and important for one product. In Germany all these drugs were 100% reimbursed, while in France, depending on actual benefit (AB) ratings, reimbursement levels varied from non-reimbursement to 100%. At time of analysis, reimbursement status was granted in France for only 4 products (15% for one drug, 65% for one drug and 100% for 2 drugs). In Germany, OD prices were about 20% higher than in France before rebates, and about 20% lower after rebates. CONCLUSIONS: Substantial improvement for OD were less frequently acknowledged by German HTA than by French HTA and prices appeared to be lower in Germany than in France. However, price volume agreements in France might have contributed to hidden discounts. Access level of OD appeared higher in Germany.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PSY75
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Pricing Policy & Schemes
Disease
Rare and Orphan Diseases