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TL;DRAMNOG is the German Arzneimittelmarktneuordnungsgesetz, the law that has governed the pricing of new medicines in Germany since 1 January 2011. It ties the reimbursed price of a new active substance to its proven additional benefit over an appropriate comparator therapy, in a two stage procedure: benefit assessment first, price negotiation second.
Before AMNOG, a manufacturer set the price of a new medicine and it stayed there. AMNOG did not introduce a price control in the ordinary sense. It introduced a sequence: the company still sets the launch price, but a clock starts on the day of launch, and at the end of it the price is replaced by a negotiated Erstattungsbetrag whose level depends on what the evidence showed. The interesting part of AMNOG is not either stage on its own, it is how the timeline and the price interact.
The two stages sit in two different laws, they run in a fixed order, and they answer two different questions.
The separation is deliberate. The G-BA does not negotiate prices and the GKV-Spitzenverband does not grade evidence. Stage 1 produces a finding, and that finding becomes the input to stage 2.
The zweckmäßige Vergleichstherapie (zVT), or appropriate comparator therapy, is the yardstick. § 35a SGB V requires the manufacturer to demonstrate the "medizinischer Zusatznutzen im Verhältnis zur zweckmäßigen Vergleichstherapie": additional benefit is never measured in the abstract, only against a specified existing therapy.
This is where AMNOG procedures are usually won or lost. The G-BA determines the zVT, and it is determined before the dossier is written. A trial that compared the new medicine against something other than the zVT can be scientifically excellent and still produce "kein Zusatznutzen belegt", because it did not answer the question that was asked. The dispute in most AMNOG cases is not about whether the data are good, it is about whether they are against the right comparator.
Roughly twelve to fifteen months from launch, and the deadlines are statutory rather than customary. The dossier is due "spätestens zum Zeitpunkt des erstmaligen Inverkehrbringens", at the latest on the day the medicine first reaches the market, which is why the AMNOG clock and the launch are the same event.
| Month | Step | Legal basis |
|---|---|---|
| 0 | Launch of the medicine and submission of the dossier to the G-BA, at the latest on the day of first marketing. A new indication triggers a dossier four weeks after authorisation. | § 35a Abs. 1 SGB V |
| 0 to 3 | Benefit assessment, conducted by the G-BA itself or commissioned to the IQWiG or a third party. | § 35a Abs. 2 SGB V |
| 3 | The Nutzenbewertung is completed and published on the internet. | § 35a Abs. 2 SGB V |
| 3 to 6 | Stellungnahmeverfahren: manufacturers, associations and experts comment in writing and orally. | § 35a Abs. 3 SGB V |
| 6 | G-BA Beschluss on the Nutzenbewertung, within three months of publication. It becomes part of the Arzneimittel-Richtlinie. | § 35a Abs. 3 SGB V |
| 7 | The Erstattungsbetrag takes effect from this month, even though it has not been agreed yet. It is applied retroactively once it exists. | § 130b Abs. 3a Satz 2 SGB V |
| 6 to 12 | Negotiation of the Erstattungsbetrag between the GKV-Spitzenverband and the manufacturer, within six months of publication of the Beschluss. | § 130b Abs. 1 SGB V |
| 12 to 15 | If no agreement is reached, the Schiedsstelle sets the Erstattungsbetrag within three months. | § 130b Abs. 4 SGB V |
Read the month 7 row against the month 12 row and the commercial logic of AMNOG appears. The price is agreed at month 12 at the earliest, possibly at month 15 through arbitration, but it applies from month 7. The gap is settled in cash: § 130b Abs. 3a Satz 9 SGB V requires that "die Differenz zwischen Erstattungsbetrag und dem bis zu dessen Vereinbarung tatsächlich gezahlten Abgabepreis einschließlich der zu viel entrichteten Zuschläge nach der Arzneimittelpreisverordnung und der zu viel entrichteten Umsatzsteuer auszugleichen" ist, the difference between the reimbursement amount and the dispensing price actually paid until it was agreed, including overpaid AMPreisV surcharges and overpaid VAT, has to be settled.
That month 7 date is recent. Until the GKV-Finanzstabilisierungsgesetz took effect in November 2022, the Erstattungsbetrag applied from the thirteenth month. The free pricing window therefore did not disappear, it halved, from twelve months to six. Every month between 7 and the signature is now a month of price risk carried on the manufacturer's balance sheet, and a rebate liability accruing on the payer side.
One further consequence is often missed: the Erstattungsbetrag is not only a GKV settlement figure. Under § 78 Abs. 3a Satz 1 AMG, "Gilt für ein Arzneimittel ein Erstattungsbetrag nach § 130b des Fünften Buches Sozialgesetzbuch, gibt der pharmazeutische Unternehmer das Arzneimittel zum Erstattungsbetrag ab". The negotiated amount becomes the manufacturer's actual dispensing price, so it reaches the whole market and not just statutory health insurance.
§ 5 Abs. 7 AM-NutzenV (Arzneimittel-Nutzenbewertungsverordnung) quantifies the extent of the additional benefit in six graded categories. These are the categories that set the negotiating position at month 6.
| No. | Category | Meaning |
|---|---|---|
| 1 | Erheblicher Zusatznutzen | Major additional benefit: a sustained and large improvement not previously achieved. |
| 2 | Beträchtlicher Zusatznutzen | Considerable additional benefit: a marked improvement over the comparator therapy. |
| 3 | Geringer Zusatznutzen | Minor additional benefit: a moderate improvement, more than marginal. |
| 4 | Zusatznutzen liegt vor, ist aber nicht quantifizierbar | An additional benefit exists, but the scientific evidence does not allow its extent to be quantified. |
| 5 | Kein Zusatznutzen belegt | No additional benefit demonstrated. Note the wording: not proven, which is not the same as disproven. |
| 6 | Der Nutzen ist geringer als der Nutzen der zweckmäßigen Vergleichstherapie | The benefit is lower than that of the appropriate comparator therapy. |
Categories 4 and 5 are the ones that get misread in the trade press. "Nicht quantifizierbar" is a positive finding with an evidential gap. "Kein Zusatznutzen belegt" is a statement about the dossier, not a verdict on the molecule, and it is the most common outcome for medicines whose comparator choice went wrong.
This is the newest moving part and the least well covered. § 130b Abs. 1c SGB V lets a manufacturer declare, within five days of an agreement or arbitration decision reached by 30 June 2028, that the Erstattungsbetrag for a new active substance is not published for the duration of its data protection. The condition is evidence of a pharmaceutical research department in Germany plus relevant own projects and cooperations with public institutions in preclinical or clinical research in Germany.
Confidentiality is not free. Under § 130b Abs. 1c Satz 4, the Erstattungsbetrag for such a product is the agreed or arbitrated amount "abzüglich eines Abschlags in Höhe von 9 Prozent": less a 9 percent discount. And § 130b Abs. 4c prohibits G-BA and IQWiG publications from containing the Erstattungsbetrag for a product where a Bestimmung under Abs. 1c has been made.
The practical effect for anyone maintaining price data is that a published Erstattungsbetrag can now be legitimately absent, and its absence is a state to be modelled rather than a data gap to be chased. That is why it exists as its own field rather than as a blank.
On pharmazie.com the AMNOG figures sit in the Preisinformationen tab of the article, in a dedicated Listenpreise AMNOG block, keyed to the pack rather than the substance:
One honest limitation: the Kombinationsabschlag under § 130e SGB V is not linked to the underlying G-BA Beschlüsse here. The AMNOG price fields are present per PZN, but if your workflow depends on resolving a combination discount back to the specific G-BA decision that triggered it, that linkage is on the roadmap rather than in the product, and another source will serve you better today.
