Pharmaceutical Market Access in Europe: The Barriers Keep On Rising

The leading European markets are among the most testing in terms of the barriers to market access that they erect. France, Italy, and Spain have complex pricing and reimbursement procedures: prices are benchmarked and strictly controlled, innovation is a key factor in determining price and reimbursement status, and launch delays can be substantial. By comparison, Germany and the United Kingdom were historically free pricing markets, characterized by relatively high prices and minimal delays in launching new drugs. However, Germany is in the process of implementing a radical overhaul of its pricing system, and the United Kingdom plans to introduce major reforms in January 2014.

Questions answered in this report:

- The EU Transparency Directive states that pharmaceutical pricing procedures must be completed within 90 days, with the possibility of a further 90 days for reimbursement decision making. What are the average delays to market access in price-regulated markets? What are the pharmaceutical industry’s concerns and aspirations with regard to a prospective reform of the Transparency Directive?

- The French government has recently announced plans to reform its national pharmaceutical regulatory system. What conditions will be set for the reimbursement of new drugs? What sanctions will manufacturers face if they do not comply with deadlines for postmarketing research? What is the pharmaceutical industry’s initial reaction to the planned reforms?

- Germany introduced a radical overhaul of its pharmaceutical pricing system in January 2011. What are the key elements of the new system? How will pricing procedures vary according to a drug’s perceived level of innovation? What actions have manufacturers taken thus far in response to the reforms?

- Pharmaceutical innovation is a key criterion in reimbursement decision making in Italy. What evidence are manufacturers required to submit? How does the Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) assess innovation? What measures have been introduced to promote more-uniform access to innovative drugs across Italy?

- The pricing of new pharmaceuticals in Spain is based on a cost-plus formula. What is the basic procedure for setting prices? What other factors can have a particularly important bearing on a new drug’s price in Spain? What is the scope for postmarketing price increases?

- The U.K. government intends to introduce a value-based pricing (VBP) system when the current Pharmaceutical Price Regulation Scheme (PPRS) expires at the end of 2013. Which drugs are expected to be included in the VBP system? How is value likely to be assessed? What procedures will be applied to drugs that require postmarketing research? What concerns has the pharmaceutical industry expressed with regard to the proposed reforms?

Scope:

Markets covered: France, Germany, Italy, Spain, United Kingdom.

Processes reviewed: price setting, admission to reimbursement, health technology assessment.

Legislation assessed: Arzneimittel-Neuordnungs-Gesetz (AMNOG; Pharmaceutical Restructuring Act); Arzneimittel-Nutzenbewertungsverordnung (Pharmaceutical Benefit Assessment Order); EU Transparency Directive (89/105/EEC); Gesetz zur Stärkung des Wettbewerbs in der Gesetzlichen Krankenversicherung (Act for the Improvement of Competition in the Statutory Health Insurance System, abbreviated to the GKV-Wettbewerbsstärkungsgesetz, or GKV-WSG); Real Decreto Ley 4/2010 (Royal Decree Law 4/2010). SHOW LESS READ MORE >

Executive Summary
Strategic Considerations
Stakeholder Implications

Overview

European Environment
Market Access Delays
European Commission Consultation on Drug Pricing and Reimbursement

France
Pharmaceutical Pricing
- Standard Procedure for Setting Reimbursement Prices
- Price Setting for Innovative Drugs
Admission to Reimbursement
Health Technology Assessment
Plans for an Overhaul of the French Regulatory System

Germany
Pharmaceutical Pricing
- New Requirement for Value Dossiers
- New Price-Setting Procedures
- Initial Impact of the Pricing Reforms
- Industry Reactions to the Reforms
Admission to Reimbursement
Health Technology Assessment

Italy
Pharmaceutical Pricing and Health Technology Assessment
Admission to Reimbursement
Initiative to Promote More-Uniform Access to Innovative Drugs Across Italy

Spain
Pharmaceutical Pricing
Admission to Reimbursement
Health Technology Assessment

United Kingdom
Pharmaceutical Pricing
- Pricing of Branded Drugs Based on New Active Substances
- Pricing of Branded Drugs Based on Established Active Substances
- Patient Access Schemes
- Flexible Pricing
Prospective Overhaul of the Pricing System
- Objectives of the New System
- Initial Industry Response to Government Proposals
- Proposed New Pricing Procedure
Admission to Reimbursement
Health Technology Assessment

Outlook and Implications for the Pharmaceutical Industry

About the Author

Organizations
- Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS; French Agency for the Safety of Health Care Products)
- Agence Nationale de Sécurité du Médicament (ANSM ; National Agency for the Safety of Medicines)
- Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency)
- Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ; Pharmaceutical Commission of the German Medical Profession)
- Association of the British Pharmaceutical Industry (ABPI)
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM; Federal Institute for Drugs and Medical Devices)
- Bundesverband der Deutschen Industrie (Federal Association of German Industry)
- Centro Andaluz de Documentación e Información de Medicamentos (CADIME; Andalusian Center for Pharmaceutical Documentation and Information)
- Centro Vasco de Información de Medicamentos (CEVIME; Basque Center for Medicines Information)
- Comisión Interministerial de Precios de los Medicamentos (CIPM; Interdepartmental Committee on Pharmaceutical Prices)
- Comisión Nacional para el Uso Racional del Medicamento (CNURM; National Commission for the Rational Use of Medicines)
- Comitato Prezzi e Rimborso (CPR; Pricing and Reimbursement Committee)
- Comité de Evaluación de Nuevos Medicamentos (CANM; Committee for the Evaluation of New Medicines)
- Comité de Políticas de Calidad e Innovación (Committee on Policies for Quality and Innovation)
- Comité de Políticas para la Racionalización del Gasto Sanitario (Committee on Policies for the Rationalization of Healthcare Spending)
- Comité Economique des Produits de Santé (CEPS; Economic Committee for Healthcare Products)
- Comité Mixto de Evaluación de Nuevos Medicamentos (Joint Committee for the Evaluation of New Medicines)
- Commission de la Transparence (CT; Transparency Committee)
- Commission Evaluation Economique et de Santé Publique (CEESP; Commission for Economic Evaluation and Public Health)
- Commissione Tecnico Scientifica (CTS; Scientific and Technical Committee)
- Conferenza Stato-Regioni (State-Regional Conference)
- Cour des Comptes (Court of Accounts)
- Dirección General de Farmacia y Productos Sanitarios (DGFPS; General Directorate of Pharmacy and Health Products)
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- European Medicines Agency
- European network for Health Technology Assessment (EUnetHTA)
- Gemeinsamer Bundesausschuß der Ärzte, Zahnärzte, Krankenhäuser und Krankenkassen (GBA; Federal Joint Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds)
- Haute Autorité de Santé (HAS; National Health Authority)
- Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG; Institute for Quality and Efficiency in the Health Care System)
- Les Entreprises du Médicament (Leem; Pharmaceutical Companies)
- National Institute for Health and Clinical Excellence (NICE)
- Osservatorio Nazionale sull’Impiego dei Medicinali (OsMed; National Observatory on the Use of Medicines)
- Paul-Ehrlich-Institut
- Spitzenverband Bund der Krankenkassen (National Association of the Federation of Health Insurance Funds)
- Subdirección General de Economía del Medicamento y Productos Sanitarios (SGEMPS; General Subdirectorate of Pharmaceutical and Health Product Economics)
- Ufficio Prezzi e Rimborso (UPR; Office of Pricing and Reimbursement)
- Union Nationale des Caisses d’Assurance-Maladie (UNCAM; National Union of Health Insurance Funds)