The multiple criteria qualitative value-based pricing framework “MARIE” for new clinical status

Adjustment of drug prices after the change of their clinical status in the current drug pricing system in Japan functions as an appropriate allocation mechanism for drug expenditures under the universal health insurance system. However, the failure to incorporate a drug’s value when determining its price decreases pharmaceutical companies’ motivation to develop and launch novel drugs in Japan. In this study, we applied the value-based pricing framework MARIE to drugs with new clinical status. We estimated drug prices at the time of approval for the initial indication and new clinical status, with a total of 32 drugs by using MARIE. To estimate maximum number of patients for the new clinical status, we referred to the market expansion rate and calculated it backwards. As a result, the median change of MARIE-estimated price under new clinical status against those under initial indication was −50.24% (range, −80.36% to 16.39%). For the initial indication, the median ratio of the drug price estimated with MARIE to the initial list price was 122.12% (range, 15.57% to 2237.38%); the median ratio of actual to estimated drug price were similar to those in our previous study (125.65%). We proposed the versatile, practical, convenient, multiple criteria, qualitative VBP framework MARIE for the new clinical status. Under the MARIE system, price would only be changed when the “box” (category of the maximum number of patients) in the conversion table of the maximum number of the patients changes as the environment changes.