Evaluation of a possible predictor for Federal Joint Committee decisions on early benefit assessments according to the German act on the reform of the market for medicinal products

- We evaluated if the EVITA score is a possible predictor for AMNOG G-BA decisions.
- Our assessment is based on 40 G-BA appraisals published by end of December 2013.
- We investigated the correlation of EVITA scores and G-BA additional benefit levels.
- The related regression analyses show statistically significant correlations.
- The EVITA score may act as a possible predictor of AMNOG G-BA decisions.

ObjectivesAs of 1st January 2011 the German drug market is regulated by the act on the reform of the market for medicinal products (AMNOG). Since then the normal procedure for reimbursement of a new pharmaceutical is a benefit assessment by the joint federal committee (G-BA) which determines one of six additional benefit levels.MethodsIn order to evaluate a possible predictor of G-BA decisions, the 'evaluation of pharmaceutical innovations (EVITA)' score was calculated for 40 out of 63 dossiers and compared with published G-BA appraisals.ResultsUnivariate ordinary least squares (p < 0.001) and ordered logit regression (p = 0.008) 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%.ConclusionThe present investigation indicates that the EVITA score may have some potential to act as a possible predictor of G-BA decisions related to AMNOG early benefit assessments.