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- AMNOG-Monitor Information · Analysis · Research (2 MB)
Dear AMNOG Monitor readers,
At the annual "Handelsblatt Jahrestagung Pharma" conferencee in Berlin (29.02.-01.03.2024) there was a palpable sense of optimism in the pharmaceutical industry due to the government's adjustments of its pharma strategy and the planned Medical Research Act (Medizinforschungsgesetz; MFG). Investments worth billions by Lilly, NovoNordisk, Daiichi and Merck demonstrated the confidence in Germany as a business location. The pharmaceutical industry creates disproportionately high added value as long as access to innovations is maintained. Therefore, obstacles such as the GKV-FinStG with its guard rails and combination discounts should be "removed again", as was heard several times, for example from Han Steutel, president of the vfa, a business association. The health insurance funds, on the other hand, are loooking critical at the planned concessions in terms of their financial viability, and in particular at the idea of confidential reimbursement prices.
In March 2024, the new Arzneiverordnungsreport 2023 was published. It shows an increase in expenditures for pharmaceuticals of 5.2% to €52.85 billion in the year 2022. Main cost drivers were innovative oncological and orphan drugs. https://link.springer.com/book/10.1007/978-3-662-68371-2
At the plenary session of the G-BA, Prof. Josef Hecken announced that the long-time Deputy Director of IQWiG, Dr. Stefan Lange, was leaving the institute. He is moving to a renowned law firm as a consultant. A prescription exclusion was established for Semaglutid (Wegvoy®) for the indication weight loss, in accordance with the legal requirements for lifestyle drugs (Section 34(1) 7 SGB V).
In total, there were six new G-BA resolutions on early benefit assessment in March 2024 (see table below). 7 new procedures were initiated. 12 new active substances received a positive opinion from the CHMP.
On 01. April 2024 Eladocagene Exuparvovec (Upstaza®) is reintroduced to the German market. The gene therapy had originally been discontinued before the reimbursement price was published.
There are a number of new features in the AMNOG Monitor that we hope will make your work easier:
- Overview and price history of all PZNs of all AMNOG products (incl. re-imports) with export function
- The list of combination discounts has been extended to include information on their validity periods
- Overview of all alpha IDs and ORPHAcodes accepted by the G-BA
We are happy to offer free trainig sessions for you, and for any new colleagues, regarding the new functions and the efficient use of the AMNOG Monitor. Please contact us with date suggestions.
New reimbursement prices of AMNOG products are available here.
EMA Positive Opinions for new drugs are shown here.
Kind regards,
Dr Johannes Hankowitz and Christian Rieke
Resolutions March 2024
Start Resolution | Procedure (no.) | Brand name | Indication | Additional benefit (best subpopulation) |
---|---|---|---|---|
Sirolimus | Hyftor® | Facial angiofibroma in tuberous sclerosis, ≥ 6 years. | 100% Hint for non-quantifiable additional benefit (Orphan) | |
Pegunigalsidase alfa | Elfabrio® | Morbus Fabry | 100% no additional benefit | |
Nivolumab (27) | Opdivo® | Melanoma (stage IIB or IIC), adjuvant therapy, ≥ 12 years, monotherapy). | 100% no additional benefit | |
Talquetamab | Talvey® | Multiple myeloma, at least 3 prior therapies | 100% Hint for non-quantifiable additional benefit (Orphan) | |
Risdiplam (2) | Evrysdi® | Spinal muscular atrophy, < 2 months | 100% no additional benefit (Orphan) | |
Lonapegsomatropin | Skytrofa® | Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years. | 100% Hint for non-quantifiable additional benefit (Orphan) |