AMNOG Explained: Germany’s G-BA Early Benefit Assessment

AMNOG is the German law that links the price of a new medicine to the added benefit it shows over existing treatment. Since 1 January 2011, companies launching a medicine with a new active substance have, as a rule, had to submit a dossier to the Federal Joint Committee (G-BA), which rules on its added benefit about six months later. That ruling is the starting point for price negotiations with statutory health insurance.

Two features set AMNOG apart from systems such as NICE technology appraisal in England. The dossier contents listed in § 35a include costs to statutory health insurance but no cost-effectiveness analysis, so the standard procedure has no cost-per-QALY threshold. And the rating mainly decides price rather than access: for the first six months after launch, insurers pay the company’s own price. For the general logic of assessment and appraisal, see the HTA process step by step.

Who does what in AMNOG: G-BA, IQWiG, GKV-Spitzenverband and the arbitration board

Four bodies share the work. The G-BA decides on added benefit, IQWiG usually assesses the evidence, the GKV-Spitzenverband negotiates the price, and an arbitration board sets it if talks fail.

• G-BA: impartial members plus representatives of doctors, dentists, hospitals and the health insurance funds. Patient representatives can put topics on the agenda but cannot vote. The G-BA sets the comparator, runs the hearing and adopts the binding resolution.
• IQWiG: the scientific institute the G-BA commissions to assess dossiers for non-orphan medicines. Its assessment informs the decision; it does not make it.
• GKV-Spitzenverband (GKV-SV): negotiates the reimbursement amount, in consultation with the private health insurers’ association.
• Arbitration board: an impartial chair, two further impartial members and two representatives each of the GKV-SV and the pharmaceutical industry associations.

The AMNOG procedure step by step: from dossier to reimbursement amount

The standard AMNOG timeline runs about a year: dossier at launch, assessment by month three, G-BA resolution by month six and a negotiated price by around month twelve, applied retroactively from month seven.

For a new indication, the dossier is due within four weeks of approval. If a dossier is missing, or incomplete despite a request, added benefit is deemed not proven.

The orphan medicine zanidatamab shows the pace in practice: first placed on the German market on 15 February 2026, assessment published on 15 May, oral hearing on 22 June, G-BA resolution on 6 August 2026.

The appropriate comparator therapy (zVT) and G-BA advice

The appropriate comparator therapy, or zVT (zweckmäßige Vergleichstherapie), is the treatment against which added benefit must be shown. The G-BA sets it, and added benefit only counts against it.

Under § 6 AM-NutzenV, the comparator must be appropriate according to generally recognised medical knowledge, preferably a therapy backed by endpoint studies, and must reflect the care patients would actually receive without the new medicine. It can be a non-drug therapy, best supportive care or watchful waiting; off-label use qualifies only exceptionally. Medicines in the same class face the same comparator.

If pivotal trials used a different control arm, the dossier has to rely on indirect comparisons, which assessors judge with the methods in our guide to network meta-analysis and population-adjusted indirect comparisons.

Hence the value of early advice. Under § 35a(7) SGB V, companies can ask the G-BA about the comparator and the studies to submit. Advice is charged for, held within eight weeks of receiving the documents and, before phase III, should involve the regulators BfArM or PEI.

The IQWiG dossier assessment, hearing and G-BA resolution

The IQWiG dossier assessment tests the company’s evidence and proposes a conclusion on added benefit within three months of the dossier deadline. The G-BA then hears comments and decides within a further three months.

The G-BA can assess the dossier itself or commission IQWiG or third parties. The dossier is IQWiG’s primary data source, but the institute can run its own searches and regularly consults medical experts and patients. Its 2024 working paper drew on 667 dossier assessments and 266 addenda from 2011 to 2022.

The resolution sets out the extent and certainty of added benefit, the patient groups concerned, treatment costs and requirements for quality-assured use. It is published, with an English version within a month, and can be time-limited. It binds the price negotiation and prescribing rules; a medicine without added benefit that fits a reference price (Festbetrag) group is placed in it.

For orphan drugs and medicines with conditional or exceptional-circumstances approval, the G-BA can require data collection alongside routine use, reviewed at least every 18 months, followed by a new assessment and price. Companies can also request reassessment on new evidence, no earlier than a year after the resolution.

The six added benefit categories in the G-BA benefit assessment

§ 5(7) AM-NutzenV defines six categories for the extent of added benefit: major, considerable, minor, non-quantifiable, no added benefit proven, and less benefit than the comparator. The G-BA must use one of them, without qualifying additions.

Added benefit means improvement in patient-relevant outcomes such as mortality, morbidity, quality of life and side effects, judged in light of disease severity. IQWiG sets an extent for each outcome using confidence-interval thresholds: for mortality, “major” requires the upper limit of the 95% confidence interval of the relative risk to fall below 0.85. These statistics are covered in Module 3: Biostatistics.

The G-BA’s results pages add two procedural outcomes: added benefit deemed proven for reserve antibiotics, and deemed not proven when no dossier was submitted. France uses a different scale; see our guide to SMR and ASMR ratings at HAS.

Certainty of added benefit: proof, indication and hint

Every conclusion also carries a level of certainty. In descending order these are proof (Beleg), indication (Hinweis) and hint (Anhaltspunkt), giving conclusions such as an indication of a considerable added benefit.

IQWiG notes that surrogate endpoints and indirect comparisons increase uncertainty. The logic resembles GRADE, taught in Module 4: Evidence Synthesis.

Orphan drugs in AMNOG and the €30 million threshold

For orphan drugs, added benefit is deemed proven by the marketing authorisation, so the G-BA only rates its extent, using the four positive categories. The privilege ends once statutory health insurance sales exceed €30 million over twelve calendar months.

No comparator is set. Where the data do not allow quantification, the G-BA must say whether that reflects the limits of science or incomplete evidence. Zanidatamab was rated a “hint for a non-quantifiable additional benefit”; its only comparative evidence was an indirect comparison with an external patient population.

Once sales pass the threshold, measured at pharmacy prices including VAT, the company has three months from the G-BA’s request to submit full evidence against a comparator. The GKV-FinStG of 2022 lowered the threshold from €50 million.

AMNOG price negotiation with the GKV-Spitzenverband and arbitration

After the resolution, the company and the GKV-Spitzenverband have six months to agree a reimbursement amount; if they fail, the arbitration board sets it within three months. Either way, the amount applies from the seventh month after launch.

The free pricing period

For the first six months, statutory insurance pays the company’s price. The negotiated amount originally applied from the thirteenth month; the GKV-FinStG of November 2022 brought this forward to the seventh. Because negotiations run beyond month six, any difference is refunded retroactively.

What drives the amount

§ 130b(3) SGB V bases the amount on the extent and certainty of added benefit. A medicine with no added benefit and no reference price group should not cost more per year than the comparator; if added benefit is deemed not proven because of a missing or incomplete dossier, it should cost appropriately less. Where several comparators were named, the most economical is the benchmark. For proven added benefit, the annual therapy costs of comparable medicines are considered.

The agreement

The GKV-SV normally schedules four negotiation rounds. According to the GKV-SV, the agreed amount also becomes the price for privately insured and self-paying patients. Agreements should include a price-volume rule; failing that, an automatic annual adjustment applies from the fourth year after launch. Agreements can be terminated after a year, or sooner after a new benefit assessment.

Since the Medical Research Act (Medizinforschungsgesetz) of October 2024, a company with a research unit and research projects in Germany can opt, within five days of an agreement, to keep the amount out of public price listings in return for an extra 9% discount. The GKV-SV says this covers substances first negotiated after 1 January 2025; it applies to agreements or awards made by 30 June 2028.

How the G-BA benefit assessment shapes the price: a hypothetical example

The benefit rating does not set a price, but it fixes the negotiating frame. Take a hypothetical Drug N, launched at annual therapy costs of €48,000 (€4,000 a month), against a generic comparator costing €24,000 a year (€2,000 a month).

1. Hint for a minor added benefit: N can earn a premium over €24,000, settled by negotiation or arbitration. The law sets no formula.
2. No added benefit proven: without a reference price group, N should cost no more than €24,000 a year, half its launch level.
3. No dossier submitted: added benefit is deemed not proven, and annual costs should be appropriately below €24,000.

If outcome 2 is agreed in month 12, insurers paid €4,000 instead of €2,000 a month for months 7 to 12, so the company refunds €12,000 per patient treated throughout (ignoring pharmacy surcharges and VAT, which are also adjusted). The first six months are untouched. The decisive choices, comparator and endpoints, were made years earlier in trial design.

AMNOG reforms: GKV-FinStG 2022, Medical Research Act 2024 and GKV-BStabG 2026

AMNOG has been tightened and loosened several times. Most recently, the 2026 Contribution Rate Stabilisation Act (GKV-BStabG) repealed the price guardrails added by the 2022 GKV Financial Stabilisation Act (GKV-FinStG).

The guardrails had required, for example, that a medicine with no added benefit over a patent-protected comparator cost at least 10% less per year, and that a minor or non-quantifiable added benefit over such a comparator not raise annual costs. Both went in July 2026; the basic rule remains that no added benefit means no higher annual costs than the comparator.

How EU joint clinical assessment reports feed into AMNOG

Since 12 January 2025, cancer medicines with new active substances and advanced therapies have been subject to an EU joint clinical assessment (JCA). The JCA report describes relative effects but draws no conclusion on overall added value, so the G-BA still rates added benefit and frames the price.

Under the 2025 AM-NutzenV amendment, companies can reference evidence in their European dossier, and the G-BA must consider published JCA reports; IQWiG was told to do the same. Orphan medicines join the JCA in 2028 and all other medicines in scope in 2030; see our guide to the EU joint clinical assessment.