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Pharmaceutical Pricing and Reimbursement in Italy, 2008

Decision Resources, Inc., May 2008, Pages: 30


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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.



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