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Pharmaceutical Pricing and Reimbursement in Italy, 2008


Description: Introduction

Italy was the only major pharmaceutical market to experience a decline in 2007.The country’s leading pharmaceutical-industry association has warned the Italian government that without a radical change in Italian pharmaceutical policy, the industry’s competitiveness in the global market will be severely compromised, and Italy will soon be overtaken in the global rankings by other major pharmaceutical markets.

Get the Answers You Need to Shape Your Strategy

- The Italian government has repeatedly used mandatory price freezes or cuts to reduce pharmaceutical spending. How do the Italian prices compare with prices in other major pharmaceutical markets? How has the industry reacted to these rigid policies? What can pharmaceutical companies do to avoid pricing restrictions?

- In addition to establishing a reference pricing system for off-patent drugs, the Italian government has assigned patent-protected medicines to homogeneous therapeutic categories that are subject to price ceilings. How extensive are these cost-containment systems? What are the consequences of exceeding reimbursement limits?

- The recently enacted Finance Act 2008 will introduce company-specifi c annual pharmaceutical budgets and other reforms. How will the budgets be calculated? How will they benefit innovative drugs? What will be the consequences of exceeding the budget? What is the early reaction of the pharmaceutical industry to these reforms?

- The generics market in Italy is considerably smaller than in other countries. What steps have been taken to promote greater use of generics? What branded drugs will lose patent protection in Italy in 2008?

Scope

- The national healthcare system (SSN) is a relatively recent innovation in Italy: the government has made radical changes to the system over the past 30 years and more cost-containment measures are expected; the majority of cost restrictions are aimed at the pharmaceutical industry; regional authorities have increased responsibility for enforcing the national pharmaceutical budget.

- Italy’s policy on pharmaceutical prices is not encouraging for manufacturers of branded drugs: constant price cuts have eroded pharmaceutical sales; manufacturers are legally obligated to reduce their prices to hospitals; Italy’s diagnosis-related group system is a great concern to physicians; reference pricing is another pharmaceutical restriction.


Contents: Executive Summary
Strategic Considerations
Stakeholder Implications
Overview
Organization and Funding of the Italian Healthcare System
Pharmaceutical Prices in Italy
Price Setting
Reimbursement of Outpatient Medicines
Cost-Containment Measures
Pharmaceutical Budget
Price Controls
Reference Pricing
Price Ceilings for Patent-Protected Drugs
Prescribing Restrictions
Promoting Greater Use of Generics
Regional Patient Copayments
Promoting Good Prescribing Practice
Reimbursement of Hospital Medicines
Health Technology Assessment
Outlook for the Italian Pharmaceutical Market

Tables
1 Multilateral Comparison of Average Ex-Manufacturer Prices of Branded Medicines in Select Markets as a Percentage of UK Average Ex-Manufacturer Prices, 1992-2004
2 Italian Prices of Best-Selling Drugs as a Percentage of US and European Average Prices, 2006
3 Prices of Leading Biologics in the Major Markets as a Percentage of US Prices
4 Pharmaceutical Reimbursement Categories in Italy
5 Targets of Key Pharmaceutical Cost-Containment Measures in Italy
6 Key Trends in the Italian 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 US Prices, 2006
2 Retail Prices of 300 Best-Selling Italian Prescription Medicines in Leading Markets as a Percentage of Italian Prices, 2006
3 Comparative Timetables for Pricing and Reimbursement Before and After 2004
4 Average Duration for Pricing and Reimbursement of Select Drug Categories, 2006
5 Annual Sales of Drugs Facing Patent Expiration in Italy in 2008


Companies Mentioned - Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) - Associazione Italiana di Oncologia Medica (AIOM, Italian Association for Medical Oncology) - Assogenerici (the Italian pharmaceutical association for the generics industry) - Comitato Interministeriale per la Programazzione Economica (CIPE; Interdepartmental Committee for Economic Planning) - Comitato Prezzi e Rimborso (CPR; Pricing and Reimbursement Committee) - Comitato Tecnico Scientifi co (CTS; Scientific and Technical Committee) - Commissione Unica del Farmaco (CUF; National Pharmaceutical Commission) - Farmindustria - Federazione Nazionale Unitaria dei Titolari di Farmacia Italiani (Federfarma; National Federation of Italian Pharmacy Owners) - Società Italiana di Farmacia Ospedaliera edei Servizi Farmaceutici delle Aziende Sanitarie (SIFO; Italian Society for Hospital Pharmacy and Health Authority Pharmaceutical Services)


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