OBJECTIVES:

Reimbursement of medical devices based on Heath Technology Assessment (HTA) has become increasingly important. In Canada, decision-making is highly decentralized, and evaluations of devices are not mandatory on a national level; local level stakeholders are the final decision-makers for reimbursement based on allocated budgets, clinical need, and healthcare objectives. This research aims to explore the current HTA landscape of medical devices in Canada.

METHODS:

Secondary research using publicly available sources was conducted to understand reimbursement/HTA processes for medical devices on a national and provincial level. Sources included Canadian Agency for Drugs and Technologies in Health (CADTH), provincial HTA body websites, International HTA Database, and published literature from 2015-2022.

RESULTS:

From 2015-2022, 35 full HTAs (20% of all full HTAs) were conducted for medical devices. CADTH completed four national HTAs to provide objective evidence on optimal use of market-approved devices for local level payers’ decision-making (except Ontario and Quebec).

Provincial level HTA is generated dependent on local resources and need, e.g., to contextualize CADTH HTA. Highly populated provinces (i.e., British Columbia, Alberta, Quebec, Ontario) have provincial HTA agencies/processes, which accounted for 86% of medical device HTAs (n=18 from Ontario Health; n=12 from Institut national d'excellence en santé et en services sociaux (INESSS), Quebec). Although other provinces rely on HTA produced by independent agencies/organisations, no relevant HTAs were identified.

Hospital/regional level HTA supports reimbursement and purchasing decisions, mostly in Ontario and Quebec. Typically, processes are informal, and evaluations are requested from senior administration/physicians, or policy committees within the hospital. One HTA was conducted by CHU (hospital in Quebec).

CONCLUSIONS:

A small proportion of HTAs in Canada were for medical devices, with the majority conducted by provincial HTA bodies in Ontario and Quebec. Given the complexity of the landscape, manufacturers should look for tailored access strategies of devices in each province.