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AMNOG-Monitor
Analysis · Pricing · Prediction
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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 AMNOG Monitor readers,
Thank you for the encouraging feedback on the new AMNOG monitor analysis options that went live in September. The step-by-step instructions are designed to guide you through making the most of the options. In the weeks ahead, we will be offering a number of online training courses to help you get to know the AMNOG Monitor even better. We look forward to our continued cooperation with you.
The first two Digital Health Applications (DiGA) have been available for prescription and have been eligible for reimbursement by statutory health insurance funds since 15 October 2020 (Kalmeda for tinnitus and Velibra for certain anxiety disorders). In each case, the prescription now includes the DIG dosage form as well. A list of the apps eligible for reimbursement can be found on the BfArM website. https://diga.bfarm.de/de/verzeichnis
The new framework agreement between the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the National Association of Statutory Health Insurance Physicians (KBV) calls for an expenditure increase of 4.6% in 2021, primarily due to the use of innovative medicinal products. https://www.kbv.de/media/sp/Rahmenvorgaben_Arzneimittel_2021.pdf
According to the 2020 Arzneiverordnungsreport, which provides information on the cost of prescription drugs, total expenditure by statutory health insurance funds rose by 5.3% to €251.9 billion. Spending on medicinal products within the statutory health insurance funds rose by a below-average 4% to stand at €41.1 billion, mainly due to the higher discounts received by health insurance funds in 2019. Thanks to discount agreements, insurers were able to save €4.8 billion, with reimbursements attributable to AMNOG negotiations accounting for €3.6 billion in savings and fixed reimbursement rates resulting in a reduction of €8.2 billion in total. Further patent expirations in 2020 and the use of biosimilars offer additional potential for savings to finance the wide range of innovations. https://www.springer.com/de/book/9783662621677
The new DAK Report for 2020 writes that the AMNOG procedure is a system that has proved its worth over the past 10 years. However, it also states that there is still need for improvement, especially due to the new authorisation procedure (PRIME). Under PRIME, only limited scientific evidence will be available upon market entry, necessitating further investigations to validly assess the additional benefit in everyday healthcare situations, according to the report.https://www.dak.de/dak/bundesthemen/dak-amnog-report-2020-2331046.html
October 2020 saw nine new G-BA resolutions, the results of which are presented in the following table.
| Procedure (no.) | Brand name | Indication | Additional benefit (highest subgroup)
|
|---|---|---|---|
| Venetoclax (4) | Venclyxto® | Chronic lymphocytic leukemia (CLL) | 100% no additional benefit |
| Insulin glargin / Lixisenatid (2) | Suliqua® | Diabetes mellitus type 2 | 100% no additional benefit |
| Givosiran | Givlaari® | Acute hepatic porphyria | 100% Indication of considerable additional benefit |
| Darolutamid | Nubeqa® | Prostate carcinoma | 100% Indication of considerable additional benefit |
| Brigatinib (2) | Alunbrig® | non-small cell lung carcinoma (ALK+ NSCLC) | 50% Hint for considerable additional benefit |
| Trifluridin / Tipiracil (3, reassessment) | Lonsurf® | Colorectal carcinoma, pretreated patients | 100% Hint for minor additional benefit |
| Cobicistat (2) | Tybost® | HIV infection | 100% no additional benefit |
| Avelumab (3, reassessment) | Bavencio® | Merkel cell carcinoma | 100% no additional benefit |
| Apalutamid (3, reassessment) | Erleada® | Prostate carcinoma (mHSPC) | 100% Indication of minor additional benefit |
In October 2020, changes in manufacturer's prices / reimbursement prices were only seen for Ropeginterferon alfa-2b (Besremi®) and Vestronidase alfa (Mepsevii®).
Kind regards
Dr Johannes Hankowitz