OBJECTIVES: Providing access for patients with the innovative drugs and rationalizing spending for them is a key priority for every decision-making system in healthcare. The aim of our research was to develop and validate the drug innovativeness assessment tool allowing to adopt the health technology assessment process for that drugs and to incorporate the therapeutic value into pricing and reimbursement system.

METHODS: The set of the two groups therapeutic value criteria (drug features and «unmet disease needs») was developed by health specialists survey and relative importance of each was appraised with swing weighting method. Then, we have designed the MCDA based model, which assessed the integral rate of drug’s innovativeness. For each criterion linear functions were constructed based on the minimum and maximum criteria values. Integral innovativeness rate was determined as a sum of the product of the criteria weights and their values.

RESULTS: The most valuable criteria of innovativeness among drug features is drug's impact on quality-adjusted life-years with weight 0,346 and among disease features is quality-adjusted life-years related to relevant disease (without treatment) with weight 0,312. The following criteria have the minimal weights: new action mechanism/new molecule (0,172) and disease prevalence (0,214). Based on the weights of the criteria we have developed the scale, which includes three innovation levels corresponding with the integral rate: 0-1,099 – no innovativeness, 1,100-1,499 – low innovativeness and 1,500-2,195 – high innovativeness.

CONCLUSIONS: Implementation of the drug innovativeness assessment in decision-making process connected with reimbursement status or pricing is an important and flexible tool for any health care system. Development of such kind of instrument allows to evaluate the therapeutic value of new drugs transparently and pay for it relatively.