OBJECTIVES:

Tremendous innovative medical technologies (MedTech) have emerged to improve patients’ clinical benefits in recent years. However, lack of solid data on the long-term clinical effectiveness of innovative MedTech leads to clinical and budget uncertainty. Pay-for-Performance risk sharing arrangements (P4PRSAs) can help to address uncertainty concerns.

This study aims to analyze the application and prospect of P4PRSAs for MedTech and provides a reference for the payers and healthcare providers on the value access of innovative MedTech in China.

METHODS:

We conducted a literature review to identify relevant publications of P4PRSAs practice for MedTech in both China and worldwide and analyzed key agreement elements in this study. In addition, expert interviews validated key agreement elements and further application.

RESULTS:

The findings of literature review and expert interviews implicated that the practices related to P4PRSAs for MedTech were still at its preliminary stage in China. We found that P4PRSAs were mainly carried out in economically developed provinces or cities of China such as Shanghai, Zhejiang, and Xiamen. Key agreement elements including product selection, monitoring indicator selection, risk sharing ratio determination, and partner selection are crucial for the design and implementation of P4PRSAs for MedTech at current stage. The monitoring indicators were related to product and disease types in which most of P4PRSAs used measurable indicators such as the positive detection rate, surgical complication rate.

CONCLUSIONS:

To assure the successful design and implementation of P4PRSAs of MedTech in China, the key considerations will include keeping a close eye on relevant healthcare policy, satisfying key stakeholders’ needs, selecting proper products and establishing appropriate RSA scheme. This study suggests that P4PRSAs can effectively support the value access for MedTech and promote the use of innovative MedTech in the context of medical insurance payment reform in China.