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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Identify decision-paths and trends in early benefit assessment. The AMNOG monitor is indispensable for managers and decision-makers in market access, pricing and reimbursement. 

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Dear readers of the AMNOG monitor,

In June 2021, there were a further 11 G-BA resolutuions on early benefit assessments, the results of which are summarised in the following table. A total of 691 procedures have now been completed, and in 2021 alone, 135 new G-BA resolutions on early benefit assessments are expected. This is an increase of 40% compared to the old records of 2020 and 2019, respectively.

Resolutions June 2021

Ipilimumab (6) Yervoy® Non-small cell lung carcinoma (NSCLC), first line, combination with Nivolumab and platin-based chemotherapy 73% Indication of minor additional benefit
Nivolumab (13) Opdivo® Non-small-cell lung carcinoma (NSCLC), combination with ipilimumab and platin-based chemotherapy, first line 73% Indication of minor additional benefit
Perampanel (5) Fycompa® Epilepsy, focal seizures, ≥ 4 years 100% no additional benefit
Perampanel (4) Fycompa® Epilepsy, general seizures, ≥ 7 years and < 12 100% no additional benefit
Sucroferric Oxyhydroxide (2) Velphoro® Serumphosphate control in renal insuffiency, ≥ 2 until 18 years 100% no additional benefit
Olaparib (7) Lynparza® Pancreatic adenocarcinoma (AC), maintenance therapy, BRCA1/2-Mutation 100% no additional benefit
Olaparib (6) Lynparza® Prostata carcinoma (PC), progredient after hormone therapy 100% Hint for considerable additional benefit
Olaparib (5) Lynparza® Ovarian carcinoma (OC), tube carcinoma (TC), primary peritoneal carcinoma, maintenance therapy, combination with Bevacizumab 100% no additional benefit
Sebelipase alfa (2, reassessment) Kanuma® Deficency of acid lysosomal lipase (LAL) 100% Hint for non-quantifiable additional benefit
Acalabrutinib (2) Calquence® Chronic lymphocytic leukemia (CLL), combination with Obinutuzumab, first-line 25% Hint for minor additional benefit
Acalabrutinib Calquence® Chronic lymphocytic leukemia (CLL), monotherapy, first-line 25% Hint for minor additional benefit

Changes in rimbursement prices were observed in June 2021 for the following AMNOG products: Binimetinib (Mektovi®), Brigatinib (Alunbrig®),Damoctocog alfa pegol (Jivi®), Darolutamid (Nubeqa®), Encorafenib (Braftovi®), Givosiran (Givlaari®), Ivacaftor (Kalydeco®), Lorlatinib (Lorviqua®), Pegvaliase (Palynziq®), Mogamulizumab (Poteligeo®) and Venetoclax (Venclyxto®).

Digitial health care is the topic of a new expert report of the German Council of Health Experts (Sach­ver­ständigenrat Gesundheit). Against the background of the current pandemic with digital vaccination passports and containment management, this is of particular urgency. The experts conclude that Germany is far behind other countries. They plead for a targeted strategy for digital health, with a legal framework set by the public authorities, the generation of scientific evidence and quality assurance, as well as access to the findings to all stakeholders, both in terms of medical care for the individual and a targeted development of the health care system as a whole. https://www.svr-gesundheit.de/fileadmin/Gutachten/Gutachten_2021/SVR_Gutachten_2021.pdf

Speaking of digitisation: In July 2021, we will present the 100th edition of the AMNOG monitor! Instead of grand speeches, we are again implementing a number of important innovations that will help our customers in their daily work, such as a simplified and improved export of own analyses to Excel and the option to save configurations (bookmarks) for Interactive analyses, which can then be updated at the push of a button, for example whenever new G-BA resolutions become available.

We look forward to further cooperation with you.

Kind regards,
Dr Johannes Hankowitz, Christian Rieke