How AMNOG works
Under section 35a of the Fifth Book of the Social Code (SGB V), every new active substance, and every new indication, undergoes an early benefit assessment. The company submits a dossier to the Federal Joint Committee (G-BA) no later than first placing on the market. The question is not cost-effectiveness but added benefit against the appropriate comparator therapy (zweckmäßige Vergleichstherapie, zVT) that the G-BA determines.[1, 2]
The G-BA usually commissions the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the dossier. IQWiG carries out the scientific assessment for medicines without orphan status. The assessment is published within three months, together with the dossier. Companies, associations and experts can then submit written statements and take part in an oral hearing. The G-BA passes its resolution within three months of publication, so about six months after the procedure starts.[3]
The resolution states the extent of added benefit for each patient group, the number of patients, the annual therapy costs and requirements for quality-assured use. It is the basis for the reimbursement amount (Erstattungsbetrag) that the company agrees with the GKV-Spitzenverband, the National Association of Statutory Health Insurance Funds. If no agreement is reached within six months of the resolution, an arbitration board sets the terms within three months. The agreed amount applies from the seventh month after first placing on the market, and the discussions are confidential.
- LaunchDossier to the G-BAModules 1 to 5, no later than first placing on the market
- Month 3IQWiG assessment publishedWith the dossier; written statements and an oral hearing follow
- Month 6G-BA resolutionExtent and certainty of added benefit for each patient group
- Within 6 monthsPrice negotiationReimbursement amount agreed with the GKV-Spitzenverband within six months of the resolution; it applies from month 7[4]
- If neededArbitrationIf no agreement is reached; the arbitration board decides within three months
| Extent | Proof | Indication | Hint |
|---|---|---|---|
| Major | |||
| Considerable | |||
| Minor | |||
| Non-quantifiable | |||
| No added benefit proven | · | · | · |
| Lesser benefit |
Six extent categories under the AM-NutzenV; certainty graded as proof, indication or hint in IQWiG's General Methods. Together they set the basis for the price negotiation.[5]
Evidence, comparator and added benefit
The Ordinance on the Benefit Assessment of Pharmaceuticals (AM-NutzenV) sets six categories for the extent of added benefit: major, considerable, minor, non-quantifiable, no added benefit proven, and lesser benefit than the comparator. IQWiG's General Methods (version 8.0, December 2025) grade the certainty of each conclusion as proof, indication or hint, or none of these. The extent and its certainty together drive the resolution and, through it, the pricing discussions.
The zVT decides much of the outcome. Where the G-BA names several equally appropriate comparators, the company can show added benefit against each. Where it names several alternatives, the most economical one by annual therapy cost is the reference point for pricing if no added benefit is shown, and a patent-protected comparator that has not itself been assessed is costed with a 15% markdown. Companies can request a G-BA consultation on the zVT and the planned evidence, and should check that the zVT is still current when they write the dossier.
AMNOG is an evidence-based medicine assessment of patient-relevant outcomes: mortality, morbidity (symptoms and complications) and health-related quality of life. Surrogate endpoints are accepted only where their validity for the patient-relevant outcome is shown. Randomised controlled trials against the zVT carry the most weight. Where there is no direct comparison, adjusted indirect comparisons are possible, but they usually give lower certainty. See indirect treatment comparisons.
The burden of proof sits with the company. The G-BA has no duty to investigate on its own, and if evidence is not submitted in time or in full, added benefit is deemed not proven. There is no cost-effectiveness threshold in the benefit assessment. IQWiG's methods state that there is no generally accepted threshold for Germany.
The Module 1 to 5 dossier
The G-BA dossier templates are revised regularly, and the current versions date from November 2025 and April 2026. The structure is:
- Module 1: summary of the statements in the dossier, with a formal completeness checklist
- Module 2: general information on the medicine and its approved indications
- Module 3: the zVT, the number of patients with a therapeutically significant added benefit, annual therapy costs for the statutory health insurance, and requirements for quality-assured use
- Module 4: medical benefit and added benefit by patient group, with the systematic search, study results and methods
- Module 5: full study reports, protocols, statistical analysis plans, EMA assessment reports and other source documents
The G-BA publishes Modules 1 to 4 with the resolution. Module 5 stays confidential.
Orphan medicines
For medicines with EU orphan designation, added benefit is deemed proven by the marketing authorisation. The company does not need to prove added benefit against a zVT, but it must still quantify the extent of added benefit and state the strength of the evidence. Where the extent cannot be quantified, the G-BA distinguishes whether that is because of the data or because the evidence submitted is incomplete.
The privilege ends once sales to the statutory health insurance exceed 30 million euros over the last 12 calendar months. The company then has three months from the G-BA's request to submit a full dossier against the zVT. The G-BA can also require routine practice data collection, after which the medicine is reassessed and the reimbursement amount agreed again.
How the EU JCA feeds into AMNOG
The EU-wide phase-in dates are set out in our HTA requirements comparison. Member States must give due consideration to published joint clinical assessment reports, while conclusions on added benefit remain national.
Germany has amended the AM-NutzenV and the G-BA Code of Procedure accordingly. A national section 35a dossier is still required. Companies can cross-refer to evidence already submitted at EU level for medical benefit and added benefit against the zVT, but patient numbers, therapy costs and quality-assurance requirements must be supplied nationally, and the module templates still apply. Since July 2025, IQWiG has been commissioned to take published JCA reports into account in its assessments. Our EU JCA dossier work is planned so that the JCA PICOs and the German zVT are mapped from the start.[6]
What we deliver
- Early evidence planning against the likely zVT and German patient groups
- Preparation for G-BA consultations on the zVT and the planned evidence
- Module 1 to 4 drafting, with Module 5 document management
- Systematic literature searches in line with Module 4 requirements (see systematic literature reviews)
- Indirect treatment comparisons and network meta-analyses, with sensitivity analyses
- Patient number and annual therapy cost estimates for Module 3
- Cross-referencing between the JCA dossier and the national dossier
- Support with written statements and preparation for the oral hearing
- Analysis to inform the reimbursement amount discussions
What assessors look for
- A comparator that matches the zVT exactly, including dosing and line of therapy, for each patient group
- Patient-relevant endpoints and validated instruments, not surrogates alone
- Subgroup and adverse event analyses in the form the module templates require
- Complete documents: a missing analysis is not inferred, it counts against the claim
- Consistent patient groups across Modules 3 and 4 and the JCA report
Why Evidaxia
Our EU-level work, including EU JCA dossiers, PICO scoping, indirect comparisons and network meta-analyses, and global model adaptation, is built to feed national processes such as AMNOG, and we bring that EU experience to German dossiers. Our founder is a clinician, health economist and former NICE HTA Technical Lead and Analyst, so we write evidence to the standard assessors expect. We work alongside your German market access and regulatory teams.
References
- Sozialgesetzbuch (SGB) Fünftes Buch (V): Gesetzliche Krankenversicherung, § 35a Bewertung des Nutzens von Arzneimitteln mit neuen Wirkstoffen [Internet]. Berlin: Bundesministerium der Justiz; [cited 2026 Oct]. Available from: https://www.gesetze-im-internet.de/sgb_5/__35a.html
- Gemeinsamer Bundesausschuss. The benefit assessment of medicinal products [Internet]. Berlin: Gemeinsamer Bundesausschuss; [date unknown] [cited 2026 Oct]. Available from: https://www.g-ba.de/english/benefitassessment/
- Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Allgemeine Methoden, Version 8.0 [Internet]. Cologne: IQWiG; [date unknown] [cited 2026 Oct]. Available from: https://www.iqwig.de/methoden/allgemeine-methoden_v8-0.pdf
- Sozialgesetzbuch (SGB) Fünftes Buch (V): Gesetzliche Krankenversicherung, § 130b Vereinbarungen zwischen dem Spitzenverband Bund der Krankenkassen und pharmazeutischen Unternehmern über Erstattungsbeträge für Arzneimittel [Internet]. Berlin: Bundesministerium der Justiz; [cited 2026 Oct]. Available from: https://www.gesetze-im-internet.de/sgb_5/__130b.html
- Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV), § 5 Zusatznutzen [Internet]. Berlin: Bundesministerium der Justiz; [cited 2026 Oct]. Available from: https://www.gesetze-im-internet.de/am-nutzenv/__5.html
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union. 2021 Dec 22;L458:1-32. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R2282
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.