The G-BA will incorporate the first European joint clinical assessments into the national benefit assessment framework this spring to streamline market entry for new medicinal products.
The Federal Joint Committee (Gemeinsamer Bundesausschuss) G-BA has released its 2026 work programme – Federal Joint Committee and Innovation Committee: Selection of important work topics in the year 2026 (Gemeinsamer Bundesausschuss und Innovationsausschuss: Auswahl wichtiger Arbeitsthemen im Jahr 2026) – outlining a significant shift in institutional decision-making. For the first time, the agency will integrate clinical data from the European Union EU Health Technology Assessment HTA process into its domestic evaluations. While the EU reports will provide the evidentiary baseline, the G-BA retains the sovereign power to determine the final added-value rating within the German reimbursement landscape.
Professor Josef Hecken, Impartial Chair (Unparteiischer Vorsitzender) of the G-BA, anticipates approximately 130 to 140 benefit assessment procedures throughout the year. The agency also plans to conduct 220 consultations with pharmaceutical manufacturers. This high volume of assessments coincides with a broader push for digitalisation, as the G-BA moves to automate application and expert review processes.
The 2026 agenda also addresses unmet needs in post-viral care. Following recommendations from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) BfArM, the G-BA expects to issue a final ruling on the off-label use of four active substances for Long-COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome by mid-2026. This decision will define the prescribing rights for these therapies under the statutory health insurance system.
These shifts signal a deepening institutional alignment with the EU Joint Clinical Assessment JCA framework. By adopting shared clinical data requirements, the G-BA aims to reduce duplicative evidentiary submissions and increase the predictability of national pricing negotiations. This integration ensures that the German assessment pipeline remains synchronized with supranational regulatory milestones in an increasingly harmonised European market.
Source: Gemeinsamer Bundesausschuss
Link: Gemeinsamer Bundesausschuss und Innovationsausschuss: Auswahl wichtiger Arbeitsthemen im Jahr 2026(Federal Joint Committee and Innovation Committee: Selection of important work topics in the year 2026)
Date: 20 January 2026
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