10 Years of AMNOG

Key points of the AMNOG procedure:
The AMNOG ("Arzneimittelmarktneuordnungsgesetz"), which entered into force on December 22nd, 2010, is based on the principles of evidence-based medicine using robust study data for evaluation of the added benefit. It impressively demonstrates that decisions regarding the benefit assessment of new active ingredients do not have to be made in an evidence-free environment. In this context, the added benefit of a new active ingredient is evaluated in a standardized procedure based on defined criteria immediately after its market launch in Germany. The study data submitted for the benefit assessment must be able to demonstrate whether and to what extent the new drug demonstrates an added benefit for patients compared to the currently available therapy standard ("appropriate comparative therapy"-ACT). The benefit assessment according to the AMNOG forms the scientifically sound basis for the subsequent price negotiations between the pharmaceutical entrepreneur and the GKV-Spitzenverband. In this regard, AMNOG follows the premise "the price follows the actual benefit".

• 265 pharmaceutical products in a total of 439 AMNOG procedures underwent an early benefit assessment conducted by the German Joint Government Committee (G-BA) until the end of 2019.
• 24 % of the benefit assessment procedures related to orphan drugs for the treatment of a rare disease.
• In 57 % of all AMNOG procedures an additional benefit could be proven.
• The average rebate on the launch price determined by the pharmaceutical manufacturer is about 21 %. This average rebate does not yet include confidential and selective contractual discounts. 
• For 31 % of the assessed drugs, further price reductions have been made so far, which are not directly related to the initial benefit assessment procedure but have been subsequently adjusted based on the actual prescription volumes and healthcare effects.
• Despite or precisely because of the AMNOG, the fastest market access times can be observed in Germany for both classical active ingredients and orphan drugs. In addition, the market exits are at a low level of 10 % and were not relevant for medical supply due to existing supply alternatives.
• Pharmaceutical companies are increasingly seeking early contact to the G-BA within the scope of AMNOG consulting requests on issues of study planning, endpoints, or dossier preparation.

The AMNOG Report 2020 also shows that the AMNOG's intention to realize cost containment in favor of statutory health insurance companies and to regulate German drug prices has been achieved. The AMNOG's original savings target of € 2 billion annually was exceeded by far in 2019 with more than € 3 billion in realized financial cutbacks. The savings would allow more financial resources to be available for financing new expensive drug therapies in personalized medicine and making them affordable even in advanced therapy lines. Nevertheless, the costs of new pharmaceuticals on the German market are rising rapidly and have almost quadrupled since 2010 from an average annual therapy cost of € 40,000 to currently € 150,000. Hence, to ensure a financially stable healthcare system in the future, it is therefore necessary to systematically evaluate not only the benefits of a new drug, but also its price.

Outlook about innovative high-priced and individualized therapies:
The AMNOG, designed as a learning system, is confronted with several future challenges. These challenges particularly concern the benefit assessment and the financing of new high-priced orphan drugs and ATMPs (Advanced Therapy Medicinal Products), some of which costing millions of €, for example in the field of CAR-T Cell therapies. Gene therapies are characterized by a one-off cure with high one-time costs and unpredictable long-term effects, which often lead to uncertainties and evidence gaps at the time of the initial benefit assessment. For this reason, the new instrument of a post launch data collection (anwendungsbegleitende Datenerhebung (awD); for more details please see our Whitepaper "Registry requirements for the German Benefit Assessment of pharmaceutical products" - was established in 2019 in §35a SGB V (German Social Security Code) in order to further develop the AMNOG and to adapt it to the changing healthcare market needs. A post launch data collection enables to generate additional evidence in the medicinal application ("real-world data") through independent registries with predefined endpoints in an orderly process and to make it available for a subsequent benefit assessment after 2-3 years. In order to ensure a seamless AMNOG procedure and to set up a registry at an early stage within the process, the G-BA recommends a consultation at the latest when the EMA demands additional data within the framework of a registry.