OBJECTIVES: Health Technology Assessment (HTA) decisions for medical devices (MDs) are usually not based on robust Value Frameworks (VFs), owing to lack of regulatory procedures and sub-optimal clinical evidence. Thus, the present investigation was designed to synthesize evidence pertaining to the existing VFs for MDs. There are a number of European markets that establish HTA for MDs as a hurdle to reimbursement. Given the lack of sophisticated processes so far, the research on existing frameworks establishes the starting point for MD manufacturers and demonstrates status quo of the evidence basis for MDs.

METHODS: A targeted search was carried out in PubMed and Google Scholar to identify the relevant publications reporting VFs for MDs. Also, websites of HTA institutions listed in “HTAi vortal” were searched. Relevant data were extracted and key arguments were articulated.

RESULTS: Very few HTA agencies have provided VFs specific to MDs. These include: NICE (UK), HAS (France), HIRA (South Korea), LBI (Austria), ZiN (Netherland) and CONITEC (Brazil). Also, few HTA bodies explicitly included additional sections for the evaluation of MDs. e.g. in Germany, IQWiG’s general methods include separate sections on the assessment of nondrug interventions and diagnostic procedures. In addition to HTA agencies, few other associations have provided VFs for MDs e.g. AdvaMed and MATCH. It was evident from the review, that the dimensions like learning curve, timing of assessment, wider economic implications, and instability of ICERs have not been integrated into these VFs, thus limiting their use in practical reimbursement decisions. There is a need for a nuanced VF for MDs which could be an amalgamation of the said VFs ensuring optimal patient centricity.

CONCLUSIONS: The evidence landscape has identified major touch points of patient/physician journey which are warranted to be integrated to HTA procedure to ensure robust, transparent and reproducible HTA of MDs.