COST-EFFECTIVENESS IN DRUG REIMBURSEMENT DECISION MAKING- A TOOTHLESS TIGER?

Author(s)

Franken M, Sandmann F, Koopmanschap MErasmus University, Rotterdam, Netherlands

OBJECTIVES: Since 2005, reimbursement requests for outpatient drugs claiming added therapeutic value require pharmacoeconomic evidence to obtain reimbursement in the Netherlands. This study aims to obtain insight into the role of pharmacoeconomics in actual decision making. METHODS: We studied public reimbursement reports from 2005 onwards and investigated in detail the role of pharmacoeconomics next to therapeutic value and budget impact in decision making. RESULTS: From 2005 - April 2011, the Dutch reimbursement agency evaluated 304 dossiers, 186 concerned outpatient drugs of which 113 were submitted with a claim of added therapeutic value. In total, 26 out of 113 were denied reimbursement, 60 were classified having added therapeutic value (Annex 1B), 27 were clustered with equivalent drugs (Annex 1A). Only 30% of the submissions (18 out of 60 positive 1B decisions) contained pharmacoeconomic evidence; 37%, 12% and 22% were exempted due to orphan status, being a HIV drug, or other unknown reasons, respectively. Three out of the 18 submissions with pharmacoeconomic evidence only supplied a cost-minimisation analysis, 4 only a cost-effectiveness analysis (1 alongside a cost-minimisation analysis); 11 supplied a cost-utility analysis. Uncertainty was often related to (assumed) treatment utilities and the applied pharmacoeconomic model, only 9 submissions included a cost-effectiveness plane and an acceptability curve. Interestingly, 4 (2) submissions were judged as “insufficiently (moderately) founded” pharmacoeconomic evidence but still received a positive decision, presumably due to their added therapeutic value, treatment modality, expected budget impact, or orphan status. CONCLUSIONS: Although cost-effectiveness is a formal reimbursement criterion in the Netherlands, only 18 out of 60 positively evaluated submissions contained pharmacoeconomic evidence. Only robustness of evidence is evaluated. Even “insufficiently founded” evaluations can yield positive reimbursement decisions. Hence, cost-effectiveness does not seem prominent in actual decision making, resulting in uncertainty about value for money of currently reimbursed drugs.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

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

Code

PHP105

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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