REGIONAL DRUG EVALUATION IN SPAIN- A COMPARISON AMONG COMMITTEES

Author(s)

Hernández-Pastor LJ1, Huerta A21Glaxosmithkline, Tres Cantos, Madrid, Spain, 2GlaxoSmithKline, Tres Cantos, Madrid, Spain

OBJECTIVES: Fifteen committees currently undertake drug evaluations at the regional level in Spain that serve as the basis for pharmaceutical policy decisions within primary care or specialized care above single hospitals. The objective of this study was to examine the quality of the assessment procedures under which drug evaluations are undertaken by these regional committees. METHODS: We analyzed the quality of the assessment procedures on the basis of 4 criteria: whether operating procedures (OP) are public, whether there is dialog with the marketing authorization holder (MAH) during the assessment, whether drug assessments are public, whether a full economic evaluation (EE) (i.e. costs and health outcomes are taken into account) is undertaken. We reviewed all the public information regarding OPs and drug assessments undertook by these committees. Search was conducted in Google, official bulletins and official Regional Health Systems websites, with no limits. RESULTS: In primary care, 2 out of 8 committees follow a public OP when assessing a new drug and explicitly have interaction with the MAH during the assessment. All the committees publish their assessments but none of them undertake full EEs (e.g. only drug costs are considered). Within specialized care 3 out of 7 committees follow a public OP, 2 of which interact with the MAH. 3 committees publish their assessments and also 3 undertake full EEs. Overall 33% of committees follow a public OP, 27% have interaction with the MAH during the assessment, 73% publish their assessments and 20% undertake a full EE. CONCLUSIONS: There is room for improvement in the work undertaken by regional drug evaluation committees regarding transparency of OPs, dialog with the MAH and use of EE as a tool for informing decision making.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PHP37

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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