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What is Direct Evidence-Based Policy-Making? Experience from the Drug Benefits Program for Seniors in British Columbia

Published online by Cambridge University Press:  08 November 2023

Malcolm Maclure*
Affiliation:
British Columbia Ministry of Health and Harvard School of Public Health
Tanya M. Potashnik
Affiliation:
British Columbia Ministry of Health
*
Requests for reprints should be sent to:/Les demandes de reproduction doivent être adressées à: Malcolm Maclure, Research and Evaluation Branch, Policy Planning and Economics Division, British Columbia Ministry of Health, Victoria, BC V8W 3C8
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Abstract

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Drug benefits policy-making for seniors in British Columbia has been increasingly influenced by research since 1993. The "evidence-based medicine" paradigm, which emphasizes the primacy of direct evidence from randomized control trials, inspired key policy-makers and influenced policy concerning coverage of new and existing drugs. New drugs, if more expensive than existing similar drugs, are not covered unless published randomized control trials show superior effectiveness. Indirect evidence of effectiveness, based on surrogates, is given less weight, and non-randomized studies are rarely considered. Evidence of cost-effectiveness of new drugs is reviewed separately. For existing drugs, a new reimbursement policy, Reference Based Pricing (RBP), was introduced, based on both direct and indirect evidence of comparative effectiveness of drugs. Implementation of RBP was complex and necessarily rapid, which meant that independent systematic review of evidence relevant to implementation issues was infeasible, particularly in regard to rapid prior authorization of exemptions to RBP. Contrasts between the processes for new and existing drugs provide insights into the difficulties of applying the idea of direct evidence-based policy-making in practice.

Résumé

Résumé

Depuis 1993, la recherche a de plus en plus influencé l'élaboration des politiques de prestations pharmaceutiques á l'égard des aînés de la Colombie-Britannique. Le paradigme de la «médecine fondée sur les résultats» qui met l'accent sur la prépondérance des faits probants découlant d'une étude sur échantillon aléatoire et contrôlé a dicté aux décideurs principaux leur élaboration des mesures de couverture concernant les nouveaux et les anciens médicaments. Les nouveaux medicaments qui sont plus chers que les médicaments semblables déjâ sur le marché ne sont pas couverts, sauf si des études publiées et effectuées sur échantillon aléatoire et contrôlé en démontrent la supériorité. On accorde moins de poids aux preuves indirectes fondées sur des substituts et on tient rarement compte des études non randomisées. On examine séparément les données concernant le rapport coût-efficacité des nouveaux medicaments. Dans le cas des medicaments déja sur le marché, on a mis en place un nouveau mécanisme de remboursement basé sur le prix (RBP) qui repose sur l'efficacité comparée directe et indirecte des médicaments. La mise en place du RBP a été complexe et nécessairement rapide, ce qui signifie qu'un examen systématique indépendant des mesures demise en place n'a pu être fait, plus particulièrement en ce qui concerne l'autorisation préalable rapide d'exemptions de RBP Les écarts entre les méthodes s'appliquant aux nouveaux et aux anciens médicaments nous éclairent sur les difficultés de mise en pratique de l'élaboration de politiques fondées sur la preuve directe.

Type
Research Article
Copyright
Copyright © Canadian Association on Gerontology 1997

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