OBJECTIVES: Compared to pharmaceuticals, it is more difficult to conduct HTA for medical devices (MDs) due to different efficacy dynamics and unique product life cycles. HTA methodology and guidance in China have not been established yet, while recent policies have implied the use of HTA in MDs, especially in the therapeutic medical devices (TMDs) in following years. It is important to design the HTA framework in China.

METHODS: The HTA guidelines of MDs and TMDs were reviewed from seven countries or areas and one association. Foreign guidelines were identified through internet retrieval and three published reviews. Value framework and HTA process were extracted. Besides, assessment criteria from three Chinese policies were extracted.

RESULTS: Most guidelines (n=7) conducted HTA of TMDs incorporating clinical benefit, economics and organizational factors; some guidelines (n=3) additionally incorporated regulations and fairness; very few guidelines (n=1) emphasized the inclusion of scarcity. In the assessment of clinical benefit, the impact of learning curves can be assessed using a logical framework or Bayesian approach. In the economic assessment, disutility of adverse events or effective discount due to lack skill should be included; maintenance, depreciation, disposal costs of replaced devices, additional labor costs and training costs should be included in cost calculation. In addition, cost-consequence analysis is recommended as supplement of CEA/CUA. Organizational factors are unique dimension of the HTA of TMDs. Impact of new TMDs on health system and existing treatment processes needs to be considered.

CONCLUSIONS: Combining the international experience with China’s national conditions, it is suggested that different assessments (complete, mini, rapid HTA) should be conducted for different products. For complete HTA inclusion of clinical benefit, economic, organizational factors, patient benefit, equality, social benefit, and scarcity is recommended; for mini-HTA inclusion of clinical benefit, economic and organizational factors is recommended; for rapid assessment only clinical benefit and product price is needed.