Germany - Briefings

The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is a key player in the access landscape, determining which healthcare services, including medicines, are covered, and assesses the comparative benefit provided by new drugs. Medicines showing a comparative benefit are launched at prices set by the manufacturer, who then negotiates the definitive price with the National Association of Statutory Health Insurance Funds, with the price applicable from six months after launch. Those without a comparative benefit are subject to national reference pricing.

Application-accompanying data collection (anwendungsbegleitende Datenerhebung, AbD), is a post-launch evidence-generation mechanism used to reduce clinical uncertainty remaining after regulatory approval.

Germany has long combined published list prices with confidential net reductions, chiefly through sickness fund rebate agreements and statutory rebates. Since 1 January 2025, confidentiality has become an option for AMNOG reimbursement prices through a legal option to keep the negotiated reimbursement amount off public price and product listings for eligible medicines.

Discount contracts, in the form of sickness fund rebate agreements, are a central mechanism by which individual statutory health insurance funds obtain confidential net price reductions from manufacturers without changing the published list price.

Germany’s structured early access route for medicines without marketing authorisation is compassionate use through cohort-based ‘hardship programmes’.

Germany’s health technology assessment for new medicines centres on the early benefit assessment under the Act on the Reform of the Market for Medicinal Products, (AMNOG). It is run by the Federal Joint Committee, (G-BA), with scientific assessments typically prepared by the Institute for Quality and Efficiency in Health Care, (IQWiG).

Inpatient add-on payments (Zusatzentgelte, ZE) are a core mechanism used to reimburse defined high-cost items or services in addition to the DRG case payment, within nationally specified rules and an annually updated national catalogue.

Recent reforms under the Medical Research Act (Medizinforschungsgesetz, MFG) are intended to strengthen Germany as a location for clinical research and early launches.

Before the national DRG catalogue of hospital tariffs has been updated to reflect the cost of a new, high-cost medicine , the NUB temporary innovation payment system allows hospital-level, time-limited additional payments to be agreed.

Outpatient budget protection, or ‘practice special features’ (Praxisbesonderheiten), is used within German statutory health insurance to prevent prescribers being financially penalised for clinically appropriate but atypically high medicine costs.

Germany uses reference prices (Festbeträge, FB) to cap statutory health insurance reimbursement for large parts of the outpatient medicines market. The system groups medicines that are considered comparable for reimbursement purposes and assigns a maximum reimbursable amount to each group.

Germany has a legally defined sequence of add-ons for most prescription-only medicines dispensed to outpatients through community pharmacies. The regulated elements are the maximum wholesale add-on and a fixed structure of pharmacy add-ons, with value added tax (VAT) applied on top.

Germany regulates medicines through a combination of European Union authorisation pathways and national implementation under the German Medicinal Products Act. For medicines intended for human use, scientific evaluation and regulatory decision-making are shared between European bodies, principally for centrally authorised products, and Germany’s national competent authorities for national and multi-country procedures.

After the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) has adopted its resolution on additional benefit, the National Association of Statutory Health Insurance Funds (Spitzenverband Bund der Krankenkassen, GKV-SV) negotiates a statutory reimbursement price (Erstattungsbetrag, EB) with the manufacturer.

Germany’s statutory health insurance system applies mandatory manufacturer rebates, a mandatory pharmacy discount, and a price moratorium to reduce net medicines expenditure, while generally leaving published list prices unchanged.

After a medicine is reimbursable in statutory health insurance, Germany uses binding rules and self-governance agreements to influence who receives a medicine, how it is prescribed, and what is dispensed.

Germany's healthcare system operates under a decentralised, statutory health insurance model offering universal access. Funding is primarily income-based, supplemented by private insurance and out-of-pocket payments. Healthcare services are provided by public, private, and non-profit institutions, with medicines regulated at national and European levels. Reimbursement policies balance comparative-effectiveness assessments with patient access.

In Germany, manufacturers can seek scientific advice separately from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), the Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut, PEI), and the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA). Alternatively they may opt for joint scientific advice to integrate regulatory and HTA perspectives. Choosing the right approach can streamline development, reduce risks, and optimise resource allocation.