Current System

Under Spain’s current system, the General Directorate for Pharmacy and Medical Devices is responsible for developing and implementing national pharmaceutical policy and negotiating drug prices. The Spanish medicines agency, AEMPS, issues guidelines on some new medicines to decision-makers based on health economic evaluations put together by GENESIS (Group for the Evaluation of Innovation, Standardization and Research in Drug Selection). There are no formal criteria for linking the therapeutic benefits of a drug to its price, such as, QALYs (quality-adjusted life years) in England or the ASMR benefit rating in France. Although evaluations should be based on cost-effectiveness, it is often unclear how this is done.

Meanwhile, regional Spanish HTA bodies have differing levels of influence and independence and tend to focus their evaluations on devices and diagnostics rather than new drugs. Institutes in Catalonia and the Basque Country are the most well developed and influential.

Calls Grow For New ‘Hispa-NICE’ HTA Agency In Spain

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