Construction of a comprehensive value assessment framework for renal denervation therapy: a decision-support tool for...

Renal denervation (RDN) therapy is an innovative interventional therapy for patients with refractory hypertension and antihypertensive drug intolerance. In China, four RDN products were approved by National Medical Products Administration. This study aims to construct a comprehensive value assessment framework for RDN therapy to support the rational selection and application in Chinese hospitals.

Multiple Criteria Decision Analysis (MCDA) approach was used to develop the framework. We conducted a literature review and focus group interviews to identify the list of criteria that should be included in the framework. Then, the Delphi method was applied to refine the framework. With the engagement of cardiologists and non-clinical professionals from hospitals in different regions, weights were given to each criterion by the Analytic Hierarchy Process.

The comprehensive value assessment framework for RDN therapy consists of three levels of criteria in seven domains, including seven criteria at the first level, 16 secondary criteria and 30 sub-criteria at the third level. The distribution of criteria weights at the first level is: efficacy (23.26%), safety (21.83%), qualification and suitability (16.84%), patient value (15.18%), innovation (10.65%), management value (6.22%), and cost (6.01%). The prioritized domains are efficacy, safety, qualification and suitability.

The development of a comprehensive value assessment framework for RDN can serve as a reliable and scientific tool to support the procurement reviews and decisions for RDN devices in Chinese hospitals.