Pharmaceutical Pricing and Reimbursement in France, 2008

Published by: Decision Resources

Published: Jun. 11, 2008 - 45 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Overview

Organization and Funding of the French Healthcare System

Pharmaceutical Prices in France

Pricing and Reimbursement of Outpatient Medicines

Standard Procedure for Setting Reimbursement Prices

Transparency Commission (CT)

Economic Committee for Healthcare Products (CEPS)

Price Setting for Innovative Drugs

Admission to Reimbursement

Renewal of Pricing and Reimbursement

Cost-Containment Measures

Supply-Side Restrictions

Sales Growth Limits

General Price Cuts

Individual Price Cuts

Reference Pricing

Taxation

Controls on Detailing Visits to Physicians

Demand-Side Restrictions

Prescribing Restrictions

Physician Prescribing Audits

Medical Control Strategy

Personal Medical Dossiers

Patient Copayments

Promoting Increased Use of Generic Drugs

Parallel Imports

Pricing and Reimbursement of Hospital Medicines

Price Setting

Temporary Authorizations for Use

Hospital Prescribing to Outpatients

Prospective Payment

National Frame of Reference for the Appropriate Use of Expensive and Innovative Drugs

Health Technology Assessment

Outlook for the French Pharmaceutical Market

Appendix: Glossary of French Terms Used in This Report

Tables

1. Multilateral Comparison of Average Ex-Manufacturer Prices of Branded Medicines in Select Markets as a Percentage of U.K. Average Ex-Manufacturer Prices, 1992-2004

2. French Prices of Best-Selling Drugs as a Percentage of U.S. and European Average Prices, 2006

3. Prices of Leading Biologics in the Major Markets as a Percentage of U.S. Prices, 2006

4. Relationship Between SMR Ratings and Reimbursement Rates by Disease Severity

5. Targets of Key Pharmaceutical Cost-Containment Measures in France

6. Key Trends in the French Prescription Drug Market: Implications for the Pharmaceutical Industry

Figures

1. Average Prices of Leading Biologics, Small-Molecule Drugs, and Pharmaceuticals Overall in the Major Markets as a Percentage of U.S. Prices, 2006

2. Percentage of Drugs Awarded Various Medical Benefit (SMR) Ratings

3. Percentage of Drugs Awarded Various Improvement in Medical Benefit (ASMR) Ratings

4. Average Duration of Pricing Process for Branded and Generic Drugs, 2006

5. Structure of the Pharmaceutical Market by Drug Reimbursement Rate, 2006

6. Generics’ Share of the Pharmaceutical Market, 1999-2006

7. Generics Penetration Rates, June 2007

A. Ten Most Common Chronic Disorders in France, 2006

Sidebar

Potential Changes to the Management of Chronic Disorders

Abstract

• The French pharmaceutical market offers many attractions for drug manufacturers, but the country’s 2008 budget limits the growth rate for pharmaceutical costs to just 1.4%. What steps does the government plan take to maintain the country’s healthcare system? What challenges does the government face as it struggles to curb escalating national healthcare expenditures? How will the government encourage the use of generics?
• The standard procedure for setting reimbursement prices in France begins with pricing analyses conducted by three governing bodies. How do these agencies determine a drug’s reimbursement rate? What recourse does the manufacturer have to challenge a given rate? What plans does France’s Ministry of Health have for increasing the independence and scientific credibility of the decision-making process?
• The French government has introduced several reforms to stimulate greater use of generics. What is the French government doing to encourage physicians to overcome their bias toward branded drugs? What type of pricing restrictions are in place to promote generics substitution? How does the country’s generics erosion rate compare with more mature generics markets?

• How France funds its healthcare system: statutory health insurance system; employment-related levies and taxes; government-run insurance for individuals in other categories; privately paid complementary health insurance.
• Cost-containment measures: sales growth limits; price cuts; reference pricing; taxation; prescribing restrictions; physician prescribing audits; medical control strategy; patient copayments; reimbursement restrictions for drugs of limited effectiveness; promotion of use of generic drugs.
• Pricing and reimbursement of drugs: social security system covers drugs dispensed in public hospitals; “global budget” allocated to public hospitals; private hospitals receive activity-based payment; national frame of reference for the good use of expensive and innovative drugs; price setting for innovative drugs; admission to reimbursement; renewal of pricing and reimbursement.
• Health technology assessment (HTA): HTA authorities in France, the United Kingdom, and Germany work together to exchange research results.
• Outlook for the French pharmaceutical market: advantages and challenges for research-based manufacturers in France; overhaul of national healthcare system expected to be announced in 2008.

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