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TL;DRThe negotiated reimbursement amount (Erstattungsbetrag) is the reimbursement price for a patent-protected medicine with a new active substance, negotiated between the manufacturer and the GKV-Spitzenverband under § 130b SGB V once the AMNOG benefit assessment is finished. It becomes the new nationwide dispensing price, replacing the free launch price.
The reimbursement amount is the second half of the AMNOG mechanism. The first half, the benefit assessment under § 35a SGB V, answers a scientific question: does the medicine do more than the established therapy? The reimbursement amount answers the commercial follow-up: given that finding, what is it worth? The two are joined by a clock that starts on the day of launch, so the price the manufacturer sets on day one is provisional from the outset.
The negotiation is between the GKV-Spitzenverband (the umbrella body of the statutory health insurers) and the pharmaceutical company, in agreement with the Verband der Privaten Krankenversicherung. § 130b Abs. 1 SGB V opens: "Der Spitzenverband Bund der Krankenkassen vereinbart mit pharmazeutischen Unternehmern im Benehmen mit dem Verband der privaten Krankenversicherung ... Erstattungsbeträge für Arzneimittel". The starting point is the G-BA Beschluss on the Zusatznutzen: the additional-benefit rating fixed by the Gemeinsamer Bundesausschuss is the central input to the price. A high rating strengthens the manufacturer's position, a "kein Zusatznutzen belegt" outcome collapses it against the guardrails described below. The reimbursement amount is agreed as a discount on the manufacturer's list price, and the manufacturer grants that discount on delivery.
The negotiation runs on statutory deadlines that are counted from the events of the AMNOG procedure, not from the negotiation itself. The sequence, from launch to a binding price, runs as follows.
The pivotal detail sits between these steps. Under § 130b Abs. 3a Satz 2 SGB V the agreed reimbursement amount "gilt ... ab dem siebten Monat nach dem erstmaligen Inverkehrbringen eines Arzneimittels", it applies from the seventh month after launch, even though the negotiation does not conclude until month twelve at the earliest, or month fifteen through arbitration. The price is therefore applied retroactively, and the difference between it and the price actually paid in the meantime is settled after the fact.
| Month | Step | Legal basis |
|---|---|---|
| 0 | Launch at a freely set price, dossier submitted to the G-BA at the latest on the day of first marketing. | § 35a Abs. 1 SGB V |
| 3 | Nutzenbewertung completed and published. | § 35a Abs. 2 SGB V |
| 6 | G-BA Beschluss on the extent of the Zusatznutzen. | § 35a Abs. 3 SGB V |
| 7 | Reimbursement amount takes effect from this month, applied retroactively once agreed. | § 130b Abs. 3a Satz 2 SGB V |
| 6 to 12 | Negotiation of the reimbursement amount within six months of the Beschluss. | § 130b Abs. 1 SGB V |
| 12 to 15 | Schiedsstelle sets the terms within three months if no agreement. | § 130b Abs. 4 SGB V |
The full month-by-month reading of the procedure, including the six Zusatznutzen categories, is covered in AMNOG.
§ 130b Abs. 3 SGB V sets caps, the so-called Leitplanken, that bind the negotiation and the Schiedsstelle to the annual therapy costs of the zweckmäßige Vergleichstherapie (zVT) when the benefit rating is weak. The baseline is Satz 1: the reimbursement amount is agreed "auf Grundlage des ... festgestellten Ausmaßes des Zusatznutzens". Where an additional benefit is not shown, the following cost ceilings apply.
| Benefit finding | Cap on annual therapy costs | Basis |
|---|---|---|
| Kein Zusatznutzen, comparator still patent-protected | At least 10 percent below the zVT | § 130b Abs. 3 Satz 2 |
| Kein Zusatznutzen, comparator no longer protected | Not higher than the zVT | § 130b Abs. 3 Satz 3 |
| Zusatznutzen not quantifiable | Appropriately lower than the zVT | § 130b Abs. 3 Satz 4 |
| Several appropriate comparators exist | The most economical alternative applies | § 130b Abs. 3 Satz 6 |
These guardrails were tightened by the GKV-Finanzstabilisierungsgesetz that took effect in November 2022, the same reform that moved the effective date of the reimbursement amount forward from the thirteenth to the seventh month. The practical effect is that a weak assessment now translates into a hard cost ceiling rather than an open negotiation.
§ 130e SGB V adds a separate deduction on top of the reimbursement amount. When a medicine with a new active substance is dispensed in a combination that the G-BA has flagged under § 35a Abs. 3 Satz 4, the statutory funds receive "einen Abschlag in Höhe von 20 Prozent des Abgabepreises", a 20 percent discount on the dispensing price, applicable since 1 May 2023. The Abschlag ends once the G-BA finds at least a considerable additional benefit for the combination. This is a distinct mechanism, keyed to combination use, and it does not change the underlying reimbursement amount of the single product.
Three different instruments set what a statutory fund pays for a medicine, and they apply to different products. Confusing them is a common error in market-access work.
| Instrument | Legal basis | Applies to | Set by |
|---|---|---|---|
| Negotiated reimbursement amount | § 130b SGB V | New patent-protected active substances after AMNOG assessment | Negotiation, GKV-Spitzenverband and manufacturer (or Schiedsstelle) |
| Festbetrag | § 35 SGB V | Groups of medicines with the same or comparable active ingredients or effect, where alternatives exist | Reference price set by the GKV-Spitzenverband on G-BA groupings |
| Rabattvertrag | § 130a Abs. 8 SGB V | Individual products, typically generics, per single fund | Bilateral rebate contract between a Krankenkasse and a manufacturer |
The reimbursement amount is a negotiated price for an innovative product, set once and applying market-wide. The Festbetrag is a reference ceiling for a whole group with therapeutic alternatives, above which the patient pays the excess. The Rabattvertrag is a confidential rebate between one fund and one manufacturer, invisible in the public price. A single medicine passes through the reimbursement-amount phase first and can later fall into a Festbetragsgruppe once its patent expires.
The negotiated reimbursement amount becomes the manufacturer's actual dispensing price under § 78 Abs. 3a AMG, so it flows into the article master data as the new price basis per pack. On pharmazie.com this surfaces in the article price fields:
One honest limitation: pharmazie.com carries the resulting price per PZN, but it does not reconstruct the negotiation itself. If a manufacturer has declared a confidential reimbursement amount under § 130b Abs. 1c SGB V, the published figure can be legitimately absent, and no data source can show a number that the statute keeps unpublished. For the G-BA Beschluss and the negotiation record you should consult the G-BA and the GKV-Spitzenverband directly.
