How To Aggregate Various Values of Medical Devices Innovation?; A Review of Empirical Work

Abstract

‘Value Appraisal Standard (VAS)’ system was introduced to recognize the premium value of innovative medical devices in Korea since 2006. To better innovation value recognition, VAS was revised and placed into official regulation effective in January 2015. The purpose of this review was to analyze how VAS contributes to value-based decision making in Korea. VAS is evaluated by clinical usefulness, cost effectiveness, and technology innovation. Two tracks exist for the VAS based on the evidence requirement for appraisal. Track A is for ones that have submitted clinical study literature and its maximum premium rate is 100%. Track B is for ones that have submitted technical file. Premium rate is calculated by multiplying weight and score in each category and summate total scores. All results of VAS from 2015 to March 2016 were reviewed and classified per appraisal track. The results were further assessed per the category and how the value for each category contributed to the decision-making. The total applied for VAS was 34, but 11 of them were excluded and 23 were appraised by HIRA (Health Insurance Review and Assessment Service). Only 6 of them were granted 10~30% premium rate. Classifying the applied products by the type of Tracks, the appraised rate was much higher for Track A. Track A was appraised by 78%, while Track B was appraised by 29%. Also, looking at the number of products which were granted premium rates, only 1 product in Track B got a 10% premium rate. Considering the type of sources accepted as evidence, most of them were Clinical Study Report and Expert Opinion. Currently, VAS has lots of area to improve since decision is made by clinical evidence rather than value in technical innovation of Medical Devices. The holistic approach in decision-making is required for better patient access.