Early benefit assessment: Detailed analysis of all G-BA resolutions

The AMNOG monitor provides current, well-founded analyses of all early benefit assessments and an overview of the negotiated reimbursement prices in Germany. It is an indispensable tool for HTA, market access and pricing managers.

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Dear AMNOG Monitor readers,

In the beginning of June 2020, the G-BA issued one more early benefit assessment.


Brand name


Additional benefit

Ivacaftor (11)Kalydeco®Cystic fibrosis (CF)100% Indication for not-quantifiable additional benefit

The German healthcare system has proved to be strong, stable and efficient in this pandemic, ensuring the public’s unrestricted access to care at all times. The G-BA – the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany – is currently relying on online conferencing to facilitate its advisory sessions and decisions. May saw nine G-BA resolutions on early benefit assessment, the results of which are presented in the following table:


Brand name


Additional benefit

Pembrolizumab (13)Keytruda®Squamous cell carcinoma (SCC), Head and neck cancer, combiantion therapy100% Hint for minor additional benefit
Pembrolizumab (12)Keytruda®Squamous cell carcinoma (SCC), Head and neck cancer, mono therapy100% Indication for considerable additional benefit
Pembrolizumab (11)Keytruda® Renal cell carcinoma (RCC)23% hint for considerable additional benefit
Neratinib Nerlynx® Breast cancer100% Indication for minor additional benefit
GilteritinibXospata® Acute myeloid leukemia (AML)100% Indication for considerable additional benefit
Dupilumab (4)Dupixent® Chronic rhinosinusitis with nasal polyps100% Hint for considerable additional benefit
Belimumab (2)Benlysta® Systemic Lupus Erythematodes (SLE)100% Indication for not-quantifiable additional benefit
Avelumab (2) Bavencio®Renal cell carcinoma23% Indication for considerable additional benefit
Betibeglogene autotemcel (autologe hämatopoetische Stammzellen)Zynteglo®β-thalassemia100% Indication for not-quantifiable additional benefit

Changes of the manufacturer's / reimbursement price were seen for: Dacomitinib (Vizimpro®), Lisdexamfetamindimesilat (Elvanse®) and Lisdexamfetamindimesilat (2) (Elvanse Adult®), Pirfenidon (Esbriet®), Pomalidomid (Imnovid®), as well as Voretigen Neparvovec (Luxturna®). A reference price was published for Tenofoviralafenamid (Vemlidy®) for the first time.
For 01 June 2020, price changes are on the horizon for Cerliponase alfa (Brineura®), Empagliflozin / Linagliptin (Glyxambi®), Fluticasonfuroat / Umeclidinium / Vilanterol (Trelegy Ellipta®), Fremanezumab (Ajovy®), Nintedanib (Ofev®), Pembrolizumab (Keytruda®) as well as Risankizumab (Skyrizi®).

The restrictions on personal freedoms to contain the spread of COVID-19 in accordance with the Protection Against Infection Act (Infektionsschutzgesetz, IfSG) are having the desired effect. The reproduction number is well below 1, and the number of new cases per day has fallen to far less than 1,000. Hospitals continue to have more than enough beds, resources and staff available to take on intensive care patients. New diagnostic options, such as extensive antibody testing and tracing apps for smartphones, are making it possible to better understand and estimate the occurrence of infection while also enabling the faster identification of sources and outbreaks. The FDA has issued special authorisation for Remdesivir, making it the first active pharmaceutical ingredient available for the treatment of COVID-19. Moreover, an initial selection of vaccine candidates is undergoing clinical trials (phase I) involving human subjects. Despite the positive results, the personal restrictions and the economic consequences are immense and cannot be put into numbers as yet.

We are pleased to hear that many of you have been using your time working from home to consult the AMNOG Monitor in the search for answers. Please do not hesitate to contact us if you have any questions or comments.

On that note, stay healthy.
Dr Johannes Hankowitz