OBJECTIVES

Health technology assessment (HTA) of medical devices (MD) may pose different challenges to those of pharmaceutical drugs. High quality randomized controlled trials (RCT) are not often available and are more difficult to conduct as clinical outcomes can be dependent on extraneous factors unrelated to the technology (e.g. familiarity, experience, and competence).

METHODS

A targeted review was conducted to assess guidelines from the following list of HTA agencies (CADTH, NICE, IQWIG, HAS, MSAC) to determine the availability of detailed recommendations directed towards MDs and to compare recommendations where available across jurisdictions.

RESULTS

Of the six HTA agencies assessed, 5 reported guidance specific towards medical devices. IQWIG, HAS, and MSAC generally recommends that RCTs be conducted to assess the efficacy and safety of the MD, however, they do acknowledge it may not always be possible to conduct an RCT. In instances whereby an RCT is unavailable, non-randomized trials can be considered in the assessment. HAS specifically outlines the requirement of a double blinded RCT (or at least with one independent investigator). In instances whereby a double blinded RCT is not possible, the agency requests that the manufacturer provide adequate justification. NICE does not specify any evidence requirement threshold in terms of trial design when evaluating medical devices, however, sufficient evidence must be presented to support the use and claims of the technology. Meanwhile, CADTH has not issued any requirements specific to medical device manufacturers in terms of clinical evidence requirements.

CONCLUSIONS

Evidence requirements for MDs are generally less detailed compared to those of pharmaceutical drugs and appear to be evaluated on a case-by-case basis depending on the technology.