ASSESSING THE ADDED VALUE OF NEW DRUGS- A MULTIDIMENSIONAL APPROACH

Author(s)

Paladio N, Sunyer B, Almazan C, Solà-Morales OCatalan Agency for Health Technology and Research, Barcelona, Spain

OBJECTIVES: In November 2008, the Program for the Assessment, Monitoring and Reimbursement of High Complexity Drugs (PASFTAC) took effect in Catalonia and the Committee for the Assessment of Hospital Use Drugs (CAMUH) was consequently appointed to give recommendations on medicines use. Our aim is to develop a tool that embraces the multidimensional aspects of added value in drug assessment. METHODS: A qualitative approach (adapted expert panel) has been used. Participants included decision makers, health economists, experts on bioethics, clinicians and pharmacists. A previous detailed review of literature was conducted for the topic under discussion. RESULTS: Several dimensions and items were identified and discussed in a single meeting. Main identified dimensions included efficacy, safety and cost-effectiveness as well as clinical relevance of outcomes, unmet therapeutic needs, ethics, and cost-oportunity. individual interviews were further conducted. Discussion and rating of dimensions and items within these will be performed in a second meeting. A pilot test will be conducted after a minimum of 10 drugs are assessed by the CAMUH (expected by September 2010). CONCLUSIONS: In a context of limited evidence dimensions other than classical efficacy, safety and cost-effectiveness need to be considered at the time of assessing added value. This new tool will contribute to that task and standardize the process at a local level.  

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PHP43

Topic

Health Service Delivery & Process of Care, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Formulary Development

Disease

Multiple Diseases

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