Impact of Independence and Transparency on Drug Availability and Time to Market: EU4 Qualitative and Quantitative Analysis of Pricing, Reimbursement, and Access Processes

ABSTRACT

Objectives: Assess how transparency and independence in health technology assessment (HTA), pricing, reimbursement and access procedures influence drug availability and time to market. Method(s) Secondary research to analyze the independence and transparency of the Spanish, French, German and Italian national pricing, reimbursement and access processes (scale high, medium, low) and how those impact drug availability and time to market. For each country, HTA, final decision and timing from European Commission (EC) approved medicines (January 2019-December 2021) were analyzed. Biosimilars, generics, hybrids, vaccines, and covid-19 medicines were excluded. Result(s) On the one hand, France and Germany are the most independent systems (medium), both driven by (1) separated clinical and economic evaluations, with some differences (2) these are assessed by autonomous agencies in Germany and (3) France has different procedures for pricing and reimbursement. Spain and Italy achieved lower scores. On the other hand, the German system is the most transparent (high) as (1) drug added value is defined using objective scales, (2) publication of detailed decisions and (3) participation of external entities in the evaluation process. France and Italy obtained medium scores;Spain got a low score. Of 138 medicines EC approved, 135 (98%) accessed Germany, 81 (58%) France, 59 (42%) Italy and 37 (26%) Spain. The mean time from EC approval to national access was 9,9+/-5.9 months in Germany (HTA outcome), France 13+/-7.1 months, Italy 17.4+/-7.2 months and Spain 19+/-7.5 months. Excluding Germany (reimbursement is automatic), France is the country with the most rapid reimbursement decisions. Conclusion(s) Higher rates of independence/ transparency seem to lead to higher availability and faster drug access to the market, providing a stable framework for all stakeholders. Best practices for improving independence include the establishment of separate evaluations for clinical and economic. Additionally, include objective scales and the active participation of external stakeholders support transparency. Copyright © 2022