Reimbursement of Medicines in Belgium: Role of Evidence-Based Medicine

Wilder, Philippe B. Van; Dupont, Alain

doi:10.1179/acb.2009.021

Cited by 6 publications

(6 citation statements)

References 9 publications

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“…This effect was not observed in recommendations by National Institute of Health and Care Excellence (NICE) in the UK [17]. Van Wilder and Dupont showed that the percentage for positive decisions by the Minister was higher for class 1 drugs (70%) than for class 2 NME (64%) since the introduction of EBM principles in reimbursement decision in Belgium [23]. In this study, the advice of the CRM was considered.…”

Section: Discussionmentioning

confidence: 77%

“…Decision making for reimbursement of drugs in general was previously analyzed in England, Wales, the Netherlands and to a limited extent in Belgium [17][18][19][20][21]23]. In the Netherlands, the type of disease for which a drug is indicated can influence reimbursement decision making since oncology drugs were more often recommended compared with drugs for other diseases [18].…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013

Pauwels¹,

Huys

Nys

et al. 2015

Expert Review of Pharmacoeconomics & Outcomes Research

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Section: Discussionmentioning

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013

Pauwels¹,

Huys

Nys

et al. 2015

Expert Review of Pharmacoeconomics & Outcomes Research

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“…The Belgian Commission on Reimbursement of Medicines (CRM), installed in January 2002, uses evidence‐based medicine (EBM) principles to evaluate the relative therapeutic value of new medicines and advises the Minister of Social Affairs who takes the reimbursement decisions and who can only deviate from the CRM proposal, which is taken on a two‐thirds majority, on either social or budgetary concerns [12, 13]. The reimbursement procedure has been described elsewhere in detail [14].…”

Section: Methodsmentioning

confidence: 99%

Access to orphan drugs despite poor quality of clinical evidence

Dupont

Wilder

2011

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The clinical evidence level of orphan medicines in European market authorization submissions is low: few randomized controlled trials, short treatment follow‐up, rarely hard clinical endpoints. • The success rate at centralized market authorization is lower for orphan drugs (62.9%) than for non‐orphan medicines (70.7%). • The burden of disease of rare diseases is high, affecting the lives of at least 30 million patients in the European Union (EU). WHAT THIS STUDY ADDS • As opposed to market authorization, orphan drugs gain reimbursement more easily than non‐orphan innovative drugs. • Lower quality of evidence of clinical efficacy and safety, more uncertainty on cost‐effectiveness and higher product prices are accepted for orphan drugs. • There is a need for collaboration between the European Commission, competent for market authorization, and the EU member states, competent for reimbursement, in assessing the therapeutic risks and benefits of orphan drugs, to reduce the evidence gap post marketing. AIM We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence. METHODS Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed. The evaluation reports of the French ‘Haute Autorité de Santé’, including the five‐point scale parameter ‘Service Médical Rendu (SMR), were examined to compare disease severity. Chi‐squared tests (at P < 0.05 significance level) were used to compare the outcome of the reimbursement decisions between orphan and non‐orphan innovative medicines. RESULTS Twenty‐five files of orphan drugs and 117 files of non‐orphan drugs were evaluated. Twenty‐two of 25 (88%) submissions of orphan drugs were granted reimbursement as opposed to 74 of the 117 (63%) non‐orphan innovative medicines (P= 0.02). Only 52% of the 25 orphan drug files included a randomized controlled trial as opposed to 84% in a random control sample of 25 non‐orphan innovative submissions (P < 0.01). The duration of drug exposure was in most cases far too short in relation to the natural history of the disease. CONCLUSIONS Orphan drug designation predicts reimbursement despite poor quality of clinical evidence. The evidence gap at market authorization should be reduced by post‐marketing programmes, in which the centralized regulatory and the local reimbursement authorities collaborate in an efficient way across the European Union member states.

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“…Minister receives recommendations, seeks advice from Minister of Budget and financial administration, and makes final decision9,17,21,62,175…”

Section: Tablementioning

confidence: 99%

Role of centralized review processes for making reimbursement decisions on new health technologies in Europe

Stafinski¹

2011

CEOR

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Background:The purpose of this study was to compare centralized reimbursement/coverage decision-making processes for health technologies in 23 European countries, according to: mandate, authority, structure, and policy options; mechanisms for identifying, selecting, and evaluating technologies; clinical and economic evidence expectations; committee composition, procedures, and factors considered; available conditional reimbursement options for promising new technologies; and the manufacturers’ roles in the process.Methods:A comprehensive review of publicly available information from peer-reviewed literature (using a variety of bibliographic databases) and gray literature (eg, working papers, committee reports, presentations, and government documents) was conducted. Policy experts in each of the 23 countries were also contacted. All information collected was reviewed by two independent researchers.Results:Most European countries have established centralized reimbursement systems for making decisions on health technologies. However, the scope of technologies considered, as well as processes for identifying, selecting, and reviewing them varies. All systems include an assessment of clinical evidence, compiled in accordance with their own guidelines or internationally recognized published ones. In addition, most systems require an economic evaluation. The quality of such information is typically assessed by content and methodological experts. Committees responsible for formulating recommendations or decisions are multidisciplinary. While criteria used by committees appear transparent, how they are operationalized during deliberations remains unclear. Increasingly, reimbursement systems are expressing interest in and/or implementing reimbursement policy options that extend beyond the traditional “yes,” “no,” or “yes with restrictions” options. Such options typically require greater involvement of manufacturers which, to date, has been limited.Conclusion:Centralized reimbursement systems have become an important policy tool in many European countries. Nevertheless, there remains a lack of transparency around critical elements, such as how multiple factors or criteria are weighed during committee deliberations.

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Reimbursement of Medicines in Belgium: Role of Evidence-Based Medicine

Cited by 6 publications

References 9 publications

Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013

Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013

Access to orphan drugs despite poor quality of clinical evidence

Role of centralized review processes for making reimbursement decisions on new health technologies in Europe

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