Identifying and Rewarding Pharmaceutical Innovation: Application in an EU Member State
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Identifying and Rewarding Pharmaceutical Innovation: Amlication in an EU Member State
Philippe Von Wilder, MPhormSc RIZIV National Insurance Agency Against Sickness and Disability, Brussels, Belgium
QiZhr, MSc Center for Statistics. Hasselt University, Diepenbeek, Belgium
Nod Veraverbeke, PhD Center for Statistics. Hasselt University, Diepenbeek, Belgium
'Ihe European Pharmaceutical Forum (EPF) issued "good pmctice" recommendations on the need to identifi and reward valuable innovation. We investigated the complianceof the B$gian reimbursementprocedure with the spm$c EPFrecommendationsbyanalyzingall110submissions for added therapeutic value (ATV) in the period 2002-2W. Prior to the reimbursement decision, a dative assessment of the therapeutic vahte was done with a binary outcome (ATVgmnted or refused). Ovemll, ATV was gmnted for 61 submissions (55%)or 10 compounds peryear. Because this number is similar to the number of new products with CDER priority review or with "impor-
Key Words Reimbursement; Innovation; Added value; Effectiveness; Pharmaceutical forum
Correspondence Address Philippe Van Wildec Head Of Department on Reimbursement of Medicines, RIZIV, Tervurenlaan "'0 Brussels. Belgium (email: [email protected]).
INTRODUCTION The European Pharmaceutical Forum (EPF), which was an initiative of the European Commission, aimed to bring together various stakeholders (pricing and reimbursement authorities of the EU member states, patient organizations, payers, pharmaceutical industry representatives, etc) in order to find commonalities in the approach toward three topics: quality of patient information on disease and treatments, use of relative effectiveness assessments in reimbursement procedures, and pricing of pharmaceuticals. The EPF terminated its activities in 2008 and issued 10 specific recommendations on these three topics toward all stakeholders (1). From a reimbursement perspective, recommendation 5 on the implementation of good practice principles for relative effectiveness assessments and recommendation 8 on the need to identify and reward valuable innovation are of primary importance. Belgium is an EU member state and the actual reimbursement procedure (in application since 2002) requests the assessment of the relative effectiveness of a new medicine prior to the reimbursement decision. Only if added value is granted can a price premium
tant to major" therapeutic benejlt granted by the French rehnbursement authority, we expect that valuable innovation has been identified. A positive reimbursement decision was obtained in 76cases (69%).GmntingofATV(Pc.001) was the most significantfactor aflecting the reimbursement decision (OR and its 95%CI: lZ9 [5.5-58.3j), suggesting the Belgian reimbursement procedure also rewards value for innovative products as EPF recommends. Because more than 50% of the variance still remains unexplained, one cannot confirm or reject the impact of other factors (financial, economic, etc) possibb affecting the reimbursement decision.
be obtained. This approach
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