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The Gemeinsamer Bundesausschuss (Federal Joint Committee) has issued a revised version of its Arzneimittel-Richtlinie/Anlage XII: (Frühe) Nutzenbewertung (Medicinal Products Directive/Annex XII: (Early) Benefit Assessment). This update integrates the legislative mandates of the GKV-Finanzstabilisierungsgesetz (GKV Financial Stabilisation Act) into the committee’s standing rules, marking a shift towards more rigorous scrutiny of high-cost therapies.
A central change involves the ‘orphan drug status’ exemption. Previously, medicines with orphan designation were granted a presumed added benefit without a full comparative assessment, provided their annual turnover did not exceed €50 million. This ceiling has now been lowered to €30 million. If sales exceed this limit within twelve calendar months, the manufacturer must submit a full dossier comparing the drug against a target-group-specific comparator chosen by the committee.
The revision also expands the committee’s powers to mandate anwendungsbegleitende Datenerhebung (application-orientated data collection). Where clinical evidence is deemed insufficient at launch – a common occurrence in niche indications – the body can now require manufacturers to collect real-world data through registries. These data are then used for a reassessment after a specified period, ensuring that initial pricing is justified by long-term outcomes.
Furthermore, the document clarifies the application of ‘guardrails’ in price negotiations. These rules dictate that the cost of drugs with no or only a ‘minor’ added benefit should generally not exceed the price of the appropriate comparative therapy.
These measures apply to all dossiers submitted from early 2026. This periodic update reflects a broader doctrine of fiscal sustainability, forcing companies to produce comparative evidence earlier in a product's life cycle. The likely impact will be increased pricing pressure on niche therapies and a higher administrative burden for developers.
Source: Gemeinsamer Bundesausschuss, G-BA
Link: Medicinal Products Directive/Annex XII: Early Benefit Assessment
Date: 21 January 2026