Author: Florian Stieglitz, Consultant
The 12th edition of the AMNOG Report, recently published by DAK-Gesundheit, arrives at a decisive moment for the German healthcare system. Against the backdrop of a challenging macroeconomic climate, rising pharmaceutical expenditures, and a new federal government taking office, the report engages in a fundamental examination of the dual objectives that shape pharmaceutical policy in Germany: promoting medical innovation and safeguarding the financial sustainability of statutory health insurance (GKV).
Pharmaceutical Spending Trends and Policy Tensions
The data presented in the report underscore the increasing pressure on the GKV budget. Pharmaceutical spending rose to € 55.3 billion in 2024 an increase of more than 10% compared to the previous year. Much of this growth is attributable to patent-protected and orphan drugs, which, despite representing a relatively small share of prescribed therapies, continue to exert a disproportionately large impact on healthcare budgets.
The report reflects on the limited effectiveness of recent cost-containment measures, such as combination therapy discounts and adjusted orphan drug thresholds, which have increased procedural complexity without delivering commensurate financial savings. Market access remains comparatively rapid, but manufacturers face mounting uncertainty related to pricing regulations, shortened free-pricing windows, and inconsistent reward structures for innovation.
The G-BA’s Perspective: Value-Based Pricing with Pragmatic Flexibility
Professor Josef Hecken, impartial chair of the Federal Joint Committee (G-BA), reaffirms the importance of maintaining AMNOG’s principle of value-based pricing tied to demonstrable therapeutic benefit. He points to the system’s strong track record in securing cost savings and ensuring rapid access, but acknowledges growing challenges—particularly with therapies entering the market based on limited or immature data, such as ATMPs and orphan drugs.
To address this, Hecken advocates for a prospective cohort model, in which interim pricing is adjusted based on real-world treatment outcomes. He sees this as a viable complement to early benefit assessment, especially under conditions of scientific uncertainty.
Hecken also references aspects of the Japanese pricing system—not to propose a wholesale shift to cost-plus pricing, but to suggest that mechanisms such as revenue-linked price adjustments and greater cost transparency could enhance Germany’s system. These tools, he argues, might support more adaptive pricing, provided they remain embedded in an evidence-based framework. For Hecken, maintaining AMNOG’s credibility will require both methodological discipline and openness to structural refinement.
Industry Concerns: Growing Misalignment and Policy Volatility
From the industry’s perspective, Patrick van der Loo (Pfizer Germany) outlines growing misalignment between innovation policy rhetoric and the realities of the AMNOG process. He points to the fact that only approximately seven percent of GKV spending is allocated to innovative medicines—despite their substantial impact on treatment outcomes.
Van der Loo emphasises that innovation is not adequately recognised in price negotiations, and that the regulatory environment has become increasingly unpredictable. The industry advocates for greater recognition of therapeutic progress, broader acceptance of real-world evidence, and a clearer separation of pricing negotiations from industrial policy debates. Manufacturers are seeking a more stable and predictable environment in which innovation is fairly valued and long-term planning is feasible.
Clinical Perspective: Preserving Therapeutic Freedom and Managing Innovation Intelligently
The National Association of Statutory Health Insurance Physicians (KBV) contributes a forward-looking clinical perspective. The organisation emphasises the increasing relevance of individualised medicine and patient-centred treatment approaches. Physicians, it argues, must retain the ability to make evidence-based therapeutic decisions without undue restriction from economic or regulatory constraints.
The KBV calls for a smarter, more adaptive system of innovation governance—one that combines evidence-based evaluation with respect for therapeutic freedom. Innovation management, in their view, must support high-quality care delivery while remaining grounded in real-world clinical decision-making.
Additional Stakeholder Positions
The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) maintains a firm position in favour of strict pricing discipline and warns against any softening of the AMNOG system’s cost-containment orientation. The AMNOG arbitration board (Prof. Kluckert) stresses the importance of procedural transparency and cautions against over-reliance on arbitration to correct systemic weaknesses. DAK-Gesundheit itself highlights the deteriorating financial stability of the statutory health insurance system and calls for credible, data-driven reform to restore budgetary balance.
Policy Proposals: Toward a More Flexible and Sustainable System
The AMNOG Report 2025 concludes with a series of reform proposals structured around three key areas.
- First, the report calls for simplification and clarification of the AMNOG process. This includes eliminating certain procedural “guardrails,” mandating full benefit assessments even for orphan drugs, and better integrating real-world evidence into both assessment and pricing negotiations.
- Second, it outlines potential cost-side measures, such as dynamically adjusting manufacturer rebates, reducing VAT on pharmaceuticals, and exploring the use of cost-based pricing mechanisms informed by R&D investment levels—potentially drawing on elements of the Japanese model.
- Third, the report addresses the revenue side, proposing expanded federal contributions to the health fund and a broader use of tax-based financing for non-insurance-related healthcare expenditures.
The report also advocates for a more indication-based understanding of innovation. Rather than tying reimbursement solely to product-level characteristics, pricing should reflect therapeutic progress within specific disease areas, fostering value without rewarding redundancy.
Strategic Implications for Market Access in Germany
The key takeaway from the AMNOG Report 2025 is that while the German market continues to value rapid access to pharmaceutical innovation, the environment for pricing and reimbursement is becoming increasingly complex. The combination of fiscal constraints, rising evidentiary demands, and policy volatility means that pharmaceutical manufacturers must plan strategically, engage early, and bring robust evidence to support their value propositions.
Our Perspective: Local Expertise and Strategic Clarity Are More Important Than Ever
At Kintiga, we help pharmaceutical companies navigate this complexity with precision. From early product positioning and AMNOG dossier development to price negotiations and stakeholder engagement, our deep understanding of the local access environment ensures that our clients are prepared for every stage of the market entry process.
In times of financial uncertainty and policy evolution, local expertise and strategic clarity are essential. We invite industry leaders to engage with us to develop future-ready access strategies that align innovation with system sustainability.
