Hostname: page-component-77c89778f8-cnmwb Total loading time: 0 Render date: 2024-07-17T09:48:35.442Z Has data issue: false hasContentIssue false

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

Abstract

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Soumerai, S.B., Ross-Degnan D, Fortess, E.E., Walser, B.L. Determinants of change in Medicaid pharmaceutical cost-sharing: does evidence affect policy? Milbank Quarterly (in press).Google Scholar
Evidence-Based Medicine Working Group. Evidence-based medicine: a new approach to teaching the practice of medicine. JAMA 1992; 268:2420-5.CrossRefGoogle Scholar
Sackett, D.L., Rosenberg, W.M.C., Gray, J.A.M., Haynes, R.B., Richardson, W.C.. Evidence based medicine: what it is and what it isn't. Br Med J 1996; 312:71-2.CrossRefGoogle Scholar
Patented Medicine Prices Review Board. Eighth annual report for the year ended December 31, 1995. May 1996.Google Scholar
Anderson, G.M., Kerluke, K.J., Pulcins, I.R., Hertzman, C., Barer, M.L.. Trends and determinants of prescription drug expenditures in the elderly: data from the British Columbia Pharmacare program. Inquiry 1993; 30:199-207.Google Scholar
Guyatt, G.H.. Evidence-based medicine. Ann Intern Med 1991; 114 (ACP J Club suppl 2):A-16.CrossRefGoogle Scholar
Sackett, D.L., Haynes, R.B.. On the need for evidence-based medicine. Evidence-based Med 1995; 1:5-6.Google Scholar
Woolf, S.H., Battista, R.N., Anderson, G.M., Logan, A.G., Wang, E.E.L.. Assessing the clinical effectiveness of preventive maneuvers: analytic principles and systematic methods in reviewing evidence and developing clinical practice recommendations. J Clin Epidemiol 1990; 43:891-905.CrossRefGoogle Scholar
Purpose and procedure. Evidence-based Medicine 1995; 1:98-9.Google Scholar
Fleming, T.R., DeMets, D.L.. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996; 125:605-13.Google Scholar
Furberg, C.D., Psaty, B.M., Meyer, J.V.. Nifedipine: dose-related increase in mortality in patients with coronary heart disease. Circulation 1995; 92:1326-31.CrossRefGoogle Scholar
Naylor, C.D.. Grey zones of clinical practice: some limits to evidence-based medicine. Lancet 1995; 345:840-2.CrossRefGoogle Scholar
Lambert, E.C.. Modern medical mistakes. Bloomington: Indiana Univ Press, 1978.Google Scholar
Soumerai, S.B., Ross-Degnan, D., Fortess, E.E., Abelson J. A critical analysis of studies of state drug reimbursement policies: research in need of discipline. Milbank Quarterly 1993; 71:217-52.CrossRefGoogle Scholar
Selke, G.W.. Reference pricing systems in the European Community. In: Mossialos, E., Ranos, C., Abel-Smith B eds., Cost containment, pricing and financing of Pharmaceuticals in the European Community: the policy-makers' view. London: LSE Health and Pharmetrica S.A. 1994; 147-60.Google Scholar
Caranasos, G.J.. Adverse CNS reactions to histamine-2 receptor blockers. ACP Journal Club 1992 (Jan/Feb); 30.CrossRefGoogle Scholar
Pharmaceutical Manufacturers Association of Canada v. British Columbia (Attorney General), [1996] B.C.J. No.1226 (S.C.), Edwards J.Google Scholar
Woollard, R.F.. Opportunity lost: a frontline view of reference-based pricing. Can Med Assoc J 1996; 154:1185-8.Google Scholar
McLaughlin, P.R.. Reference based pricing for provincial drug benefit programs. Can J Cardiol 1996; 12:16.Google Scholar
Smalley, W.E., Griffin, M.R., Fought, R.L., Sullivan, L., Ray, W.A.. Effect of a prior-authorization requirement on the use of nonsteroidal antiinflammatory drugs by Medicaid patients. N Engl J Med 1995; 332:1612-7.CrossRefGoogle Scholar
Anderson C. Measuring what works in health care. Science 1994; 263:1080-2.CrossRefGoogle Scholar
Campbell, D.T.. Reforms as experiments. Am Psychol 1969; 24:409.CrossRefGoogle Scholar
Berk, R.A., Boruch, R.F., Chambers, D.L., Rossi, P.H., Witte, A.D.. Social policy experimentation: a position paper. Evaluation Rev 1985; 9:387^429.CrossRefGoogle Scholar
Warburton, WP. Should the government sponsor training for the disadvantaged. In: Richards, J., Watson, W., eds., The Social Policy Challenge, Vol 14. CD Howe Institute (in press).Google Scholar
Maclure, M. Dr. Tom Chalmers, 1917-1995: the tribulations of a trialist. Can Med Assoc J 1996; 155:986-8.Google Scholar