How do you set a launch price that supports both reimbursement and profitability?
We support pharma, biotech and MedTech companies on pricing and reimbursement across the full lifecycle: from the launch price and the early benefit assessment under § 35a SGB V, through the reimbursement-amount negotiation under § 130b SGB V, to safeguarding against external reference pricing in subsequent markets. The real lever is the launch sequence, not the individual negotiation meeting: accept a low reimbursement amount in a reference country too early and you give that price away across the reference-basket mechanics of every market that follows.
- Pharma
- Biotech
- MedTech
- IVD
Overview
Which rules determine price and reimbursement in the German and European market?
Support across the full reimbursement lifecycle · AMNOG (§ 35a, § 130b SGB V), AM-NutzenV, EU-HTA (EU 2021/2282)
Last updated: 2026-06-13
In Germany, price and reimbursement are not a free market price but the outcome of a regulated procedure that begins with marketing authorisation and culminates in the reimbursement-amount negotiation. The levers on which the achievable price most often hinges:
- The added benefit determines the room for negotiation: the early benefit assessment under § 35a SGB V compares the new medicinal product against the appropriate comparator therapy; the extent of the recognised added benefit is the central criterion for the reimbursement amount.
- The reimbursement amount is negotiated, not dictated: under § 130b SGB V, the manufacturer and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) agree the reimbursement amount on the basis of the assessment result; without a recognised added benefit, the amount is anchored to the costs of the comparator therapy.
- The EU HTA Regulation (EU) 2021/2282 shifts part of the clinical assessment to the European level: since 12 January 2025, the Joint Clinical Assessment applies to new oncology products and to advanced therapy medicinal products (ATMPs); the joint evidence package must be in place at the time of the EMA submission.
- For medical devices, reimbursement runs through different pathways: in the inpatient setting via NUB charges under § 6 KHEntgG and, for methods involving high-risk-class medical devices, via the assessment under § 137h SGB V, not via the AMNOG procedure.
- External reference pricing couples markets: many countries derive their price from a basket of reference countries; a low price accepted early travels through this mechanic into all subsequent markets.
Services
How we support you
Launch Price & Pricing Strategy
Deriving a defensible launch price from the added-benefit hypothesis, the cost of the appropriate comparator therapy and willingness to pay. The output is a documented price corridor with a rationale for each scenario.
Launch Sequencing & ERP Management
Ordering market entries along reference-pricing logic so that a low price in one reference country does not damage the subsequent markets. The output is a prioritised launch map with reference-country dependencies.
AMNOG Support & SHI Negotiation
Preparing the benefit dossier for the early benefit assessment under § 35a SGB V and supporting the reimbursement-amount negotiation under § 130b SGB V with the GKV-Spitzenverband. The output is an evidence-backed negotiation position and a prepared negotiation mandate.
Learn more →Performance- & Volume-Based Reimbursement Agreements
Designing performance- and volume-based contract models (pay-for-performance, volume tiers, annuities) where the standard reimbursement amount does not reflect the value proposition. The output is a negotiation-ready contract draft.
MedTech & IVD Reimbursement
Clarifying the reimbursement pathway for medical devices and diagnostics via the NUB application under § 6 KHEntgG, the assessment under § 137h SGB V for methods involving high-risk-class medical devices, and the outpatient remuneration routes. The output is a secured reimbursement pathway per product.
EU HTA Preparation (Joint Clinical Assessment)
Building the joint clinical evidence package for the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282, timed to the EMA submission. The output is a JCA-ready dossier with PICO coverage.
How we work together
What it comes down to
The achievable price is decided before the first negotiation meeting. Three strands have to fit together, and in the right order: the added-benefit hypothesis determines which reimbursement amount is even negotiable under § 130b SGB V. The benefit dossier for the early benefit assessment under § 35a SGB V has to substantiate this hypothesis against the appropriate comparator therapy with robust evidence meeting the requirements of the AM-NutzenV. And the launch sequence determines whether a low price in one reference country travels through external reference pricing into the subsequent markets. Address any one of these strands too late and it becomes the bottleneck, usually the launch sequence, because it surfaces last and caps global revenue first.
For medical devices and diagnostics, a different logic applies: they do not run through the AMNOG procedure but via NUB charges under § 6 KHEntgG and, for methods involving high-risk-class medical devices, via the assessment under § 137h SGB V. For new oncology products and advanced therapy medicinal products, the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282 has applied since 12 January 2025: the clinical assessment shifts partly to the EU level, while pricing remains national. We come in precisely where the order has to be made visible, before a reimbursement amount is accepted that drags all subsequent markets down through the reference basket.
Our approach
Our approach
Step
Result
Value & price hypothesis
Documented price corridor with an added-benefit hypothesis against the appropriate comparator therapy and willingness-to-pay assumptions.
Define the launch sequence
Prioritised launch map that accounts for the reference-pricing dependencies between the target markets.
Prepare the benefit dossier
Dossier for the early benefit assessment under § 35a SGB V with an evidence-backed chain against the defined comparator therapy.
Negotiate the reimbursement amount
Prepared negotiation position and an agreed reimbursement amount under § 130b SGB V.
Design the contract model
Where appropriate, a performance- or volume-based reimbursement agreement as an alternative to the plain reimbursement amount.
Safeguard the price across markets
Aligned pricing strategy that controls external reference pricing in the subsequent markets.
Common pitfalls
Where projects commonly fail
The launch price is set too high or without reference-country logic.
A low reimbursement amount in an early-launched reference country travels through external reference pricing into all subsequent markets, and the local price advantage becomes a global price loss.
The appropriate comparator therapy is not clarified up front.
The early benefit assessment under § 35a SGB V measures the added benefit against precisely this comparator therapy; a wrong assumption here leaves the entire dossier, and the price hypothesis derived from it, open to challenge.
The benefit dossier is written from a marketing rather than an assessor perspective.
Only evidence that withstands the methodological requirements of the AM-NutzenV is recognised; value arguments without robust comparative data produce no recognised added-benefit category and therefore no negotiation leverage under § 130b SGB V.
MedTech reimbursement is treated like pharmaceutical pricing.
Medical devices do not run through the AMNOG procedure but via NUB charges under § 6 KHEntgG and, for methods involving high-risk-class medical devices, via § 137h SGB V; planning the wrong pathway costs a full reimbursement year.
The EU HTA evidence package is set up too late.
Since 12 January 2025, the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282 requires a joint clinical dossier for new oncology products and ATMPs at the time of the EMA submission; a national dossier logic alone is no longer enough for these products.
FAQ
Frequently asked questions
Sources
- Fünftes Buch Sozialgesetzbuch (SGB V), German Social Code, Book V - primary text, § 35a, § 130b, § 137h
- Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV), Medicinal Products Benefit Assessment Ordinance - primary text
- Regulation (EU) 2021/2282 on health technology assessment (EU HTA Regulation) - primary text
- Krankenhausentgeltgesetz (KHEntgG), Hospital Remuneration Act, § 6 Abs. 2 (NUB charges) - primary text
- https://theentourage.de/expertise/pricing-reimbursement/ (existing page content, revised)
Life Science Journal
Regulatory updates, straight to your inbox.
New requirements, authority decisions and practice notes. Once a month, unsubscribe any time.
Case Studies
What this looks like in practice
Regulations & standards considered
- Fünftes Buch Sozialgesetzbuch (SGB V) - German Social Code, Book V
- § 35a SGB V (early benefit assessment of medicinal products)
- § 130b SGB V (agreement on the reimbursement amount)
- § 137h SGB V (assessment of new diagnostic and treatment methods involving high-risk-class medical devices)
- Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV) - Medicinal Products Benefit Assessment Ordinance
- Regulation (EU) 2021/2282 (EU HTA Regulation)
- Krankenhausentgeltgesetz (KHEntgG) - Hospital Remuneration Act, § 6 Abs. 2 (NUB charges)
Related topics
HTA Dossier →
The benefit dossier for the early benefit assessment under § 35a SGB V
Market Access Strategy →
Reimbursement and price planning from the early development phase onward
Tender & Negotiation →
Rebate contracts and hospital tenders following the pricing stage
HEOR & Health Economics →
Health-economic models as the basis for the pricing argument
Have a concrete project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +49 89 4161170-0
info@theentourage.de
- Reply usually within one working day
- 4 offices: DE · CH · IT · US
- 100% life sciences