Elsevier, Value in Health, 7(17), p. A437, 2014
DOI: 10.1016/j.jval.2014.08.1135
Full text: Unavailable
Objectives: As of 1st January 2011 the German drug market is regulated by the act of the reorganization of the pharmaceutical market (AMNOG). Since then the normal procedure for reimbursement of a new pharmaceutical is an early benefit assessment by the joint federal committee (G-BA) which determines one of six additional benefit levels. According to AMNOG any specification of the reimbursement price shall be based on the outcomes of the early benefit assessment. Hence this assessment takes a key role for market access of a new drug in Germany which poses the question whether it is possible to predict the level of additional benefit that will be established by the G-BA. Methods: In order to evaluate a possible predictor of G-BA decisions, the ‘evaluation of pharmaceutical innovations (EVITA)’ score was calculated and retrospectively compared with 40 published G-BA decisions. The EVITA algorithm evaluates a new compound for a given indication and in relation to a relevant comparator on the basis of randomized controlled trial (RCT) evidence. EVITA translates the RCT outcomes on the therapeutic benefit and risk profile into rating points, which are expressed as a total EVITA score. Results: Univariate ordinary least squares and ordered logit regression analyses show statistically significant correlations between EVITA scores and the G-BA additional benefit levels. Moreover, for the prediction of an additional benefit level of at least ‘minor’, an EVITA score cutpoint of ≥ 3 is associated with a sensitivity of 100% and a specificity of 80%. For the prediction of an additional benefit level of at least ‘considerable’, an EVITA score cutpoint of ≥ 7.5 is associated with a sensitivity of 100% and a specificity of 93.1%. Conclusions: The present investigation indicates that the EVITA score may have the potential for the prediction of G-BA decisions related to AMNOG early benefit assessments.