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Pharmaceutical Pricing and Reimbursement in France, 2008


Description: Introduction

France invests heavily in maintaining its outstanding universal healthcare system. However, drug prices in France—already among the lowest in Europe are declining as a result of tough cost-containment measures targeted primarily at pharmaceutical companies. The government may have to pursue more radical reform in the future, and the pharmaceutical industry will have to adapt to a market that places growing emphasis on the costeffectiveness of treatments.

Get the Answers You Need to Shape Your Strategy

- 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 scientifi c 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?

Scope

- 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.


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 Benefi t (SMR) Ratings
3. Percentage of Drugs Awarded Various Improvement in Medical Benefi t (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


Companies Mentioned - Agence Française de Sécurité Sanitaire des Produits de Santé (French Agency for the Medical Safety of Health Products [AFSSAPS]) - Agence Technique de l’Information sur l’Hospitalisation (Technical Agency for Information on Hospitalization [ATIH]) - Alliance Intersyndicale des Médecins Indépendants de France (Interunion Alliance of French Independent Physicians) - AstraZeneca - Caisse Centrale de la Mutualité Sociale Agricole (MSA; Central Fund for Social and Agricultural Mutual Insurance) - Caisse Nationale d’Assurance Maladie (CNAM; National Health Insurance Fund) - Caisse Nationale d’Assurance Maladie des Professions Indépendantes (CANAM; the National Health Insurance Fund for Independent Professions) - Caisse Nationale d’Assurance Maladie des Travailleurs Salariés (CNAMTS; National Health Insurance Fund for Salaried Workers) - Collège des Economistes de la Santé (College of Health Economists) - Comité de Suivi des Génériques (Generics Monitoring Committee) - Comité Economique des Produits de Santé (Economic Committee for Healthcare Products [CEPS]) - Commission de la Transparence (Transparency Commission [CT]) - Confédération des Syndicats Médicaux Français (Confederation of French Medical Unions [CSMF]) - Haute Autorité de Santé (National Health Authority) - Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Effi ciency in the Healthcare System [IQWiG]) - Institut National de la Statistique et des Etudes Economiques (National Institute of Statistics and Economic Studies [INSEE]) - Institut National du Cancer (National Cancer Institute [INCa]) - Les Entreprises du Médicament (the French pharmaceutical industry association [Leem]) - Mission d’Evaluation et de Contrôle des Lois de Financement de la Sécurité Sociale (MECSS; Commission for the Evaluation and Monitoring of Social Security Finance Laws) - National Institute for Health and Clinical Excellence (NICE) - Servier - Syndicat des Médecins Libéraux (Union of Offi ce-Based Physicians [SMF]) - Takeda - Union Nationale des Caisses d’Assurance-Maladie (National Union of Health Insurance Funds [UNCAM]) - Union Nationale des Organismes d’Assurance Maladie Complémentaire (National Union of Complementary Health Insurance Organizations [UNOC]) - World Health Organization


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