title: 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.
abstract: OBJECTIVE
  As 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.
  
  
  METHODS
  In 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.
  
  
  RESULTS
  Univariate 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%.
  
  
  CONCLUSIONS
  The 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.
authors: AHEAD GmbH-Agency for Health Economic Assessment & Dissemination, Arndtstraße 19, 79539 Lörrach, Germany. Electronic address: bjoern.schwander@ahead-net.de.
authors: Björn
authors: B
authors: Schwander
authors: Outcomes International Ltd., Malzgasse 9, 4052 Basel, Switzerland. Electronic address: kurt.banz@outcomes.ch.
authors: Kurt
authors: K
authors: Banz
authors: University of Freiburg, Institute of Medical Biometry and Medical Informatics, Stefan-Meier-Str. 26, 79104 Freiburg, Germany. Electronic address: kaier@imbi.uni-freiburg.de.
authors: Klaus
authors: K
authors: Kaier
authors: MArS-Market Access & Pricing Strategy GmbH, Geffelbachstr. 6, 79576 Weil am Rhein, Germany. Electronic address: stefan.walzer@marketaccess-pricingstrategy.de.
authors: Stefan
authors: S
authors: Walzer
mesh_terms: D003362:Cost-Benefit Analysis; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D016527:Drug Costs / Q000706:statistics & numerical data; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005858:Germany; D033161:Government Regulation; D007356:Insurance, Pharmaceutical Services / Q000331:legislation & jurisprudence*; D009313:National Health Programs; D012044:Regression Analysis; D012051:Reimbursement Mechanisms
keywords: AMNOG; Benefit-risk assessment; Forecasting; Germany; Pharmaceutic preparations; Reimbursement mechanisms