How Will Recent Pricing Regulations Impact the Global Pricing Landscape?
Author(s)
Rémy C1, Lubojemska O2, Chawla A3, Damsgaard MF4
1Parexel International, Milan, Italy, 2PAREXEL International, London, London, UK, 3Parexel, Fremont, CA, USA, 4Parexel International, Copenhagen, Denmark
Presentation Documents
OBJECTIVES: In a challenging global economic context, pressure on drug prices has never been higher. This research aims to identify current trends in the global pricing landscape by comparing recent regulations in the US, Germany, and France.
METHODS: Using a thematic analysis approach, we investigated drug pricing measures in the Inflation Reduction Act passed in the US (2022), the Financial Stabilization Act of the German Statutory Health Insurance System passed in Germany (2022), the French law on the health insurance budget (2023), and the latest agreement between the pharmaceutical industry and Economic Committee for Health Products in France. We used a set of pre-specified criteria including overall regulation type, drug types concerned and price control methods.
RESULTS: Through new legislations, two new price control measures were introduced in the US, six in France, and five in Germany. Price control measures included price rebates (US, n=2; Germany, n=2; France, n=1), payback (France, n=1), price freeze (Germany, n=1), outcomes-based agreements (France, n=1), international reference pricing (France, n=1), reduction of free pricing period (Germany, n=1), stricter orphan drugs evaluation (Germany, n=1), price stability measure (France, n=1), and negotiation termination procedure (France, n=1). All measures applied to drugs that are covered by national health insurance but have trickledown effect on private payers. New rules targeted mainly high-cost, innovative and orphan drugs (Us, n=1; France, n=3; Germany, n=1), combination therapies (Germany, n=1), and single-source branded drugs that lost exclusivity (US, n=1). Most measures had a direct impact on launch price (US, n=1/2; France, n=5/6; Germany, n=3/5).
CONCLUSIONS: This research shows that the use of drug price control mechanisms is increasing globally, and aligned between the US and Europe. Nevertheless, Europe has an additional price control tool in the form of health technology assessment, and the discrepancy between list price in the US and Europe remains high.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
HPR18
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy, Systems & Structure
Disease
Drugs, No Additional Disease & Conditions/Specialized Treatment Areas