Market access of pharmaceuticals in Germany: Analyzing reappraisals of reimbursement decisions made by the G-BA

Abstract

Re-evaluations of time restricted appraisals during the early-benefit assessment are an option of the G-BA products with limited evidence to request new data (DAK 2018, p. 215). Research is needed to evaluate, how the evidence, the additional benefit and the price changes in the second evaluation compared to the first early-benefit assessment. The methods used to solve the lack of evidence are a comprehensive literature search and an analysis of two data sets. For identifying time restricted appraisals and re-evaluations, the data from the G-BA’s “Tragende Gründe” were analyzed systematically. The first data set consists of all re-evaluations from 01/2011 until 12/2017. The second data set for the final analysis consists of all revaluated time restricted early benefit assessments. The analysis of the second data set reviled an improvement of the overall quality of the clinical trials evaluated and accepted by the G-BA during the second evaluation. The benefit rating reviled different outcomes, depending on the subgroups/subpopulation. Regarding the prices, the results are not in relation with the change of the benefit rating and therefore dependent on other factors. In conclusion, the re-valuation is an instrument for the G-BA to request new data for potentially beneficial products.