The Medical Research Act

Exemption from AMNOG pricing guardrails if relevant proportion of clinical trials are conducted in Germany

Fri, 2024 / 07 / 05

Following significant amendments to the legal text, the so-called "guardrails" for pricing innovative medicinal products in the AMNOG process have been revised. The Financial Stabilisation Act (GKV-FinStG), which came into force in 2022, has been the subject of criticism for its perceived anti-innovation stance. However, with the adoption of the Medical Research Act (MFG) on June 4, the Act has undergone a partial revision.

The implementation of the defined measures recognizes warning signals from the pharmaceutical industry, which has had to accept some drastic disadvantages in recent years due to regulatory requirements.

Partial revision of the AMNOG guardrails

The guidelines for the pricing of new medicinal products, which only allow the negotiation of reimbursement amounts that exceed the prices of existing comparator therapies if a comprehensive additional benefit is established, signaled a regulatory paradigm shift in the previously prevailing incentive system. Medicinal products with proven additional benefits were often unable to negotiate a price premium, and in certain cases, even had to accept a discount for equivalent benefits. The lack of commercial success and the lack of monetary recognition of added value are highly problematic for the drugs concerned and undermine research efforts. The introduction of the MFG has resulted in the relaxation of these regulations. This is applicable if a relevant proportion of the clinical trial, defined by the inclusion of at least 5% of German patients in the study population, takes place in Germany. The regulatory relaxation sends an important, seemingly conciliatory signal in favor of strengthening Germany as a location for healthcare and innovation, leading to very positive reactions in the industry.

One remaining issue with the current structure is that the regulations lack specific guidance on the scope for action for medicinal products that have already reached advanced stages of authorization studies but have not yet reached the 5% hurdle for German patients in the study population. Furthermore, the possibility of renegotiating reimbursement amounts for medicinal products that have negotiated prices in compliance with the guidelines in the last two years as soon as they fulfill the requirements defined in the MFG remains unclear.

Conclusion

It is evident that the partial revision of the guardrails, which can be achieved by considering the low threshold requirements for the study population, will bring about significant improvements for price negotiations from the perspective of pharmaceutical companies. The inflexible restrictions have already undermined the German sales market's attractiveness for international sales activities, and the innovations will also significantly enhance Germany's appeal as a research location.

Seize the opportunity with SKC to circumvent the AMNOG guardrails through targeted adaptation of your study population

At SKC, we are experts in the strategic analysis and description of the patient population, which precisely maps the German target patient population for the selected positioning and/or the defined label of your drug. The legal changes offer significant opportunities for price expectations and the business case for new drugs in Germany and, as the primary first target country in Europe, also for continental European success. We have a broad network of experts, clinics, and research institutions. If you, as a pharmaceutical company, are entrusted with the generation of pivotal evidence now, in the near future, or in the future, then we can help you reach the low-threshold 5 % hurdle with minimal effort and achieve significant economic differences.

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About the author

Sven Büscher
M.Sc. Business Administration for Scientists

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