Pharmaceutical Pricing and Reimbursement in Spain, 2008

Introduction

In recent years, Spain has rapidly increased its spending on healthcare, and pharmaceuticals account for a larger share of healthcare expenditures in Spain than in most other European countries. However, Spanish drug prices are among the lowest in Europe and have been eroded by repeated mandatory price cuts. In addition, the government's strategy of promoting generics, imposing reference prices on off-patent drugs, and limiting price premiums to the most innovative drugs will present significant challenges to the pharmaceutical industry.

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• As a result of its generally low pharmaceutical prices, Spain is a major source of parallel exports to other European countries. How has the Spanish government responded to this trade? What measures have drug manufacturers taken to combat parallel exports?
• Spanish drug prices are among the lowest in Europe. How do prices in Spain compare with U.S. and European average prices? Which drugs are more expensive in Spain than in the United States?
Reference pricing has become the mainstay of the Spanish government's pharmaceutical cost-containment strategy. How extensive is the Spanish reference pricing system? What changes has the government introduced in recent months? How do pharmacists and physicians view reference pricing? How can manufacturers delay this cost control?
The government is dissatisfied with the persistent underdevelopment of the Spanish generics market. What measures have been introduced to stimulate greater use of generics? How do physicians, pharmacists, and patients regard generic drugs? Health technology assessment (HTA) is not well established in Spain. What steps have some autonomous communities taken to promote HTA? How will HTA play an important role in the future pricing and reimbursement of new medicines in Spain?

Scope

• Organization and funding of the healthcare system: spending on healthcare as a percentage of gross domestic product (GDP); pharmaceuticals' share of healthcare expenditures; relative importance of public and private health insurance; decentralization of responsibility for healthcare.
• Drug prices in Spain: comparison of launch prices in Spain and other European markets; detailed analysis of Spanish prices of 155 leading biologics and small-molecule as a percentage of U.S. and average European prices.
• Price setting and reimbursement: procedure for setting drug prices; reimbursement decisionmaking process.
• Cost-containment measures: negative lists; reference pricing; price cuts; sales tax; prescribing controls; patient copayments; prior authorization; measures to promote greater use of generics.
• Hospital reimbursement: pricing; cost-containment; hospital formularies.
• Health technology assessment: regional initiatives; new national committee to assess the therapeutic utility and cost-effectiveness of new drugs as the basis for pricing and reimbursement decisions for new drugs.
• Outlook for the Spanish pharmaceutical market: differences in sales growth rates according to drug price; recent slowdown in pharmaceutical expenditures; increasing emphasis on pharmaceutical innovation; decentralization of healthcare policy.
• National Pricing and Reimbursement Series: This report is part of the National Pricing and Reimbursement Series: Around the world, the market success of branded drugs is infl uenced by changes in healthcare systems and the growing role of cost-conscious payers. The National Pricing and Reimbursement Series analyzes the evolving pricing and reimbursement environment in seven major markets (the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan) and assesses the impact of key changes on pharmaceutical and biotechnology companies.

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