How do you negotiate the reimbursement amount under § 130b SGB V now that the GKV Contribution Rate Stabilization Act has rewritten the rules?
We prepare the § 130b SGB V reimbursement amount negotiation: benefit resolution, annual therapy costs of the comparator, price-volume arrangement and arbitration board. Under the GKV Contribution Rate Stabilization Act, paragraph 3 is rewritten, and without a price-volume arrangement a statutory adjustment applies from year four.
Overview
Which rules have applied to the reimbursement amount since July 30, 2026?
Negotiation preparation for AMNOG procedures · § 130b SGB V as of July 30, 2026, § 130e SGB V, § 35a SGB V
Last updated: October 3, 2026
The reimbursement amount is agreed between the pharmaceutical company and the National Association of Statutory Health Insurance Funds on the basis of the G-BA benefit assessment resolution. The GKV Contribution Rate Stabilization Act changed three points on July 30, 2026 that affect every pricing plan.
- Paragraph 3 is rewritten: without added benefit, the amount should not lead to higher annual therapy costs than the appropriate comparator therapy; where added benefit is deemed not proven because evidence was not submitted on time or in full, it must be set appropriately below. Where there are several alternatives, the most economical one counts.
- Volume-related terms were already mandatory before the rewrite. What is new in paragraph 1a is the case without a price-volume arrangement: an annual adjustment from the fourth year after launch is deemed agreed, using a discount rate with two parts: spending growth over the reference year times 1.7 percent, plus 1.5 percent per full 100 million euros of spending volume.
- The combination discount is gone. § 130e SGB V now governs discount agreements for groups of therapeutically comparable patented active substances, until December 31, 2030 only in five substance groups, including PD-1/PD-L1 and PARP inhibitors.
- If no agreement is reached within six months of publication of the G-BA resolution, the arbitration board sets the terms within three months under paragraph 4. Legal action against its decision has no suspensive effect.
- Under paragraph 3a, the reimbursement amount applies from the seventh month after first launch, and the difference to the price actually paid until then is settled.
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Designing the Price-Volume Arrangement
Drafting a price-volume arrangement under paragraph 1a, for example as tiers or an annual volume, modeled against the statutory adjustment that applies from year four if no arrangement is agreed.
How we work together
What it comes down to
The reimbursement amount follows from the G-BA resolution on the benefit assessment, and since July 30, 2026 different rules apply. The GKV Contribution Rate Stabilization Act rewrote paragraph 3 of § 130b SGB V: without added benefit, the amount should not lead to higher annual therapy costs than the appropriate comparator therapy, and the minimum discount and the cap for minor added benefit are gone.
Volume-related terms, now called a price-volume arrangement, were already mandatory. What is new is the consequence of leaving them out: anyone who does not agree one gets a statutory adjustment from year four that rises with spending growth and spending volume.
For the negotiation, that means the corridor is modeled from the resolution and the annual therapy costs, the volume component belongs on the table from the start, and the six-month deadline before the arbitration board is the real planning horizon.
The board consists of an impartial chair, two further impartial members and two representatives of each side (§ 130b(5) SGB V), and after its decision either side may request a cost-benefit assessment under § 35b.
Our article on the reimbursement amount describes how the room for negotiation is decided in study design. Pricing & Reimbursement sets the frame across launch price and reference markets.
Our approach
Our approach
Step
Result
Evaluate the resolution
Added benefit by patient group, appropriate comparator therapy and annual therapy costs from the G-BA resolution under § 35a(3) SGB V laid out.
Model the corridor
A price corridor under the rules of the new paragraph 3, with the most economical comparator alternative and, where relevant, the 15 percent discount.
Set the volume component
A proposal for the price-volume arrangement, modeled against the statutory adjustment under paragraph 1a.
Negotiate
A managed negotiation within the six-month deadline, with a prepared position in case of arbitration.
After the agreement
Monitoring of termination options under paragraph 7 and of triggers for renegotiation, such as a new benefit resolution.
Common pitfalls
Where projects commonly fail
Pricing models still use the guardrails of the GKV Financial Stabilization Act.
Paragraph 3 has applied in a new version since July 30, 2026; the minimum discount without added benefit and the cap for minor or non-quantifiable added benefit are no longer in it.
The price-volume arrangement is treated as a side issue.
Without an agreed arrangement, the statutory adjustment under paragraph 1a applies from year four, and the arbitration board may only set a different arrangement with both parties' consent.
The comparator therapy is costed at the most expensive alternative.
Where the G-BA has named several alternatives, the one with the lowest annual therapy costs is decisive for the caps in paragraph 3.
The combination discount is still in the calculation.
It ended with the new § 130e SGB V, which replaces it with discount agreements in five substance groups until the end of 2030.
The six-month deadline is read as room to maneuver.
After it, the arbitration board decides within three months at its own discretion on the individual case, and legal action against its decision has no suspensive effect.
Market Access, RWE & Reimbursement
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- German Social Code Book V (SGB V), § 130b, § 130e, § 35a and § 429: primary text as amended by the GKV Contribution Rate Stabilization Act, gesetze-im-internet.de
- GKV Contribution Rate Stabilization Act of July 24, 2026, BGBl. 2026 I No. 228, Article 1 Nos. 49 and 50, Article 8
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Related insights
All insights →Regulations & standards considered
- § 130b SGB V (agreement on the reimbursement amount), as amended by the GKV Contribution Rate Stabilization Act
- § 130e SGB V (discount agreements for patented active substances with therapeutically comparable effect)
- § 35a SGB V (early benefit assessment)
- § 35b SGB V (cost-benefit assessment)
- § 429 SGB V (transitional rule on the combination discount)
- GKV-Beitragssatzstabilisierungsgesetz (GKV Contribution Rate Stabilization Act), BGBl. 2026 I No. 228
Related topics
Pricing & Reimbursement →
Launch price and launch sequence before the negotiation
Stakeholder Management & Negotiation →
Negotiation management and preparation for arbitration
HEOR & Modeling →
Annual therapy costs and scenarios for the price corridor
HTA Dossier →
The benefit dossier behind the resolution and the negotiation
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