Comparing Drug and Nondrug Technologies in Comparative Effectiveness Research

Abstract

Randomised Controlled trial evidence of efficacy and safety has long been a requirement for pharmaceuticals to gain market access. In contrast, the evidence requirements for the approval of nondrug technologies, in particular medical devices, have traditionally been much lower. However, with increasing health-care costs and pressure of limited budgets, policy-makers are increasingly turning to health technology assessment (that includes consideration of comparative effectiveness and economic value) to inform their decisions on technology coverage and reimbursement. This chapter describes the differences between medical devices and drugs that impact on the assessment of their comparative clinical and cost-effectiveness.

Most international health technology assessment agencies have a common mandate to evaluate both medical devices and drugs. At this time there appears to be little or no explicit consideration by the health technology assessment community of the potential differences between medical devices and drugs either in their assessment or appraisal processes. Comparing medical devices to drugs highlights the challenges in the common assessment – both comparative effectiveness and economic evaluation – of drug versus nondrug technologies.

Appendix

Appendix Checklist of items for reporting trials of nonpharmacologic treatments^a