| Reimbursement of medicines in Belgium: role of evidence-based medicine. | |
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MedLine Citation:
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PMID: 19432024 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The European Transparency Directive requires that pricing and reimbursement decisions must be taken in a transparent, objective and verifiable way with respect of strict timelines. The Belgian competent authority integrated on January 1st, 2002 Evidence-Based Medicine (EBM) principles in the reimbursement evaluation. The present work describes the procedures and investigates whether the introduction of the EBM principles indeed affects the decision and whether it compromised the respect of strict timelines. The reimbursement decision for all new submissions except for generic drugs is preceded by an evaluation of the relative therapeutic value. There were 1285 submissions handled within the period 2002-2004 of which 159 (12.4%) related to new molecular entities. For the 824 files with valuation of the therapeutic value, the reimbursement decision was positive in 80.8% of cases. The percentage of positive decisions was dependent on the type of submission with the lowest percentages for new molecular entities and submissions for new indications (64%-71%). Line extensions and generics received a positive decision in nearly all cases (> 95%). Proof of added value by at least 1 positive superiority trial against active comparator is a requirement for obtaining a price premium: this was granted in less than 50% of the 67 submissions claiming such superiority and the odds for a negative reimbursement decision increased significantly if the applicant failed to prove added value: O.R. = 9.1 (2.3 - 35.6), indicating that clinical evidence of added therapeutic value clearly facilitates reimbursement. The introduction of the new procedure did not jeopardize the timelines. Introducing EBM principles had a significant impact on reimbursement decisions in Belgium by facilitating reimbursement with a price premium of new drugs with added value addressing unmet medical needs. |
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Authors:
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P B Van Wilder; A G Dupont |
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Publication Detail:
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Type: Comparative Study; Journal Article |
Journal Detail:
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Title: Acta clinica Belgica Volume: 64 ISSN: 0001-5512 ISO Abbreviation: Acta Clin Belg Publication Date: 2009 Mar-Apr |
Date Detail:
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Created Date: 2009-05-12 Completed Date: 2009-06-09 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0370306 Medline TA: Acta Clin Belg Country: Belgium |
Other Details:
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Languages: eng Pagination: 120-8 Citation Subset: IM |
Affiliation:
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Rijksinstituut voor Ziekte- en Invaliditeitsverzekering, Brussel, België. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Belgium Cost Savings Drugs, Generic / economics* Evidence-Based Medicine / economics* Humans Reimbursement Mechanisms / organization & administration* Retrospective Studies |
| Chemical | |
Reg. No./Substance:
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0/Drugs, Generic |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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