Since the introduction of the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2011, pharmaceutical companies (PC) must submit a dossier claiming an additional benefit (AB) of the new pharmaceutical over the appropriate comparator therapy (ACT) specified by the Federal Joint Committee (G-BA). The final decision on the AB is taken by the G-BA. In addition to the manufacturer’s dossier, submitted data, and the recommendation by IQWiG (Institute for Quality and Efficiency in Health Care), the G-BA also considers the results of the commenting procedure.
In the majority of cases, the G-BA agrees with the assessments of IQWiG. However, discrepancies can exist regarding i) the extent of the AB, or ii) whether an AB is recognised or not.
Here, we sought to evaluate the incidence and nature of differences in the AMNOG assessment outcomes for non-orphan pharmaceuticals between IQWiG and the G-BA. We also identify the reasons and assess potential drivers of a discrepancies between the G-BA and IQWiG.
Evidence requirements for orphan drugs
CRA’s Life Sciences Practice focuses on global policy, commercialization, and market access issues dedicated to orphan drug issues, including orphan evidence...