Record number of G-BA benefit assessments in 2021

Number of benefit assessments at record high
Since the introduction of the Act on the Reorganization of the Pharmaceutical Market (AMNOG) in 2011, all newly available active pharmaceutical ingredients in Germany have to undergo a benefit assessment by the G-BA to determine the extent to which they lead to therapeutic benefits for patients. These assessments by the G-BA lay the foundation for drug pricing and reached a record high of 146 assessments in 2021.

The proportion of drugs for rare diseases (orphan drugs) was around 19% in 2021, which is comparable to the share observed in previous years. By contrast, the largest share of newly approved active ingredients was observed in oncology drugs with 38%. In this context, the G-BA points out the increase in combination therapies and their associated price increase. This perceived development is counteracted by the "GKV-Finanzstabilisierungsgesetz" (read more in the SKC blog post on the recently published cabinet draft).

Five times with major added benefit
In 2021, the G-BA concluded their benefit assessments five times with a major added benefit and thus granted the highest possible added benefit category. Among the assessed active ingredients was the combination of ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis. The G-BA also granted a major added benefit for nusinersen for the treatment of the rare hereditary disease spinal muscular atrophy and for blinatumomab for the treatment of acute lymphoblastic leukemia in children.

G-BA advice meetings on the rise
In 2021, the number of requests for advice meetings conducted by the G-BA increased from 259 in the previous year to 292. The majority of G-BA advice meetings was utilized by pharmaceutical companies to ask questions about the study design during the planning of clinical studies in order to generate robust data for the subsequent benefit assessment. To improve access to the consultations, the waiting period of pharmaceutical companies for a advice meeting was reduced from eight to three months in 2021.

German HTA standards at EU level
Furthermore, the G-BA was involved in the development of the prospective EU-wide drug health technology assessment (HTA). According to plan, new active pharmaceutical ingredients, gene and cell therapies, and medical devices will be gradually assessed for their added benefit based on EU-wide harmonized assessment reports starting in 2025. The design of the joint European benefit assessment is currently being developed by a consortium of 13 member organizations (EUnetHTA21). The G-BA and IQWiG are significantly involved in this process and have expressed their strong interest in implementing the high and differentiated standards currently applied in Germany at the European level.

At SKC, we are closely following the development of the EU HTA and are actively and comprehensively participating in the public consultation process. We are therefore already advising our clients on the appropriate adjustments on the way to the EU wide benefit assessment - we implement new findings and developments directly into our daily consulting business.

DMP & ASV - implementation in practice could be broader
For a holistic view on the market access process in Germany, developments concerning the structured treatment of chronic diseases in disease management programs (DMP, according to §137f SGB V) and the treatment of complex or rare diseases within outpatient specialist care contracts (ASV, according to §116b SGB V) needs to be assessed. In 2021, the G-BA has introduced a DMP for the 10th indication: rheumatoid arthritis. Due to the fact that new DMPs have not been widely transferred into practice, the G-BA is currently analyzing underlying factors, but has already initiated the development of another DMP for the treatment of obesity.

In the area of complex diseases, the G-BA adopted two additional indications in ASV last year: chronic inflammatory bowel diseases and tumors of the brain and peripheral nerves. Similarly, to the lacking use of DMPs, there is also an ongoing project in the area of ASV contracts, to address the hurdles in this context.

Source:
Geschäftsbericht 2021 – Gemeinsamer Bundesausschuss (g-ba.de)