List of all G-BA Resolutions
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Reimbursement Price Trends
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AMNOG-Monitor
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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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Artificial intelligence (AI) prediction of additional benefits in the German AMNOG-procedure, based on millions of data points of all G-BA resolutions. Competitive intelligence for strategic planning.
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Resolutions December 2022
| Start Resolution | Procedure (no.) | Brand name | Indication | Additional benefit (best subpopulation) |
|---|---|---|---|---|
| Enfortumab Vedotin | Padcev® | Urothelial carcinoma (UC) pre-treated with platinum-based chemotherapy and PD-(L)1 inhibitor | 47% Hint for considerable additional benefit | |
| Setmelanotid | Imcivree® | Obesity and control of hunger, POMC-, PCSK1- or LEPR-deficient obesity, ≥ 6 years. | 100% Hint for non-quantifiable additional benefit | |
| Cabozantinib (8) | Cabometyx® | Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients | 100% no additional benefit | |
| Polatuzumab Vedotin (2) | Polivy® | Diffuse large B-cell lymphoma (DLBCL), combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP) | 100% Hint for non-quantifiable additional benefit | |
| Tisagenlecleucel (5) | Kymriah® | Follicular lymphoma (FL), pre-treated patients | 100% Hint for non-quantifiable additional benefit |
Dear AMNOG Monitor readers,
The Bundesrat (upper house of the German parliament) approved the GKV-Finanzstabilisierungsgesetz (GKV-FinStG) on October 28, 2022. This means that significant changes in the pricing of new active ingredients that must undergo early benefit assessment have come into force (cf. Bundesregierung). An overview of the most important changes affecting early benefit assessment & pricing can be found here in the AMNOG Monitor.
The new regulations and restrictions will lead to considerable changes for all parties involved.
We wish you a "lucky hand" in this process and hope that you can still enjoy the Advent season.
In November 2022, the G-BA passed 6 new resolutions on early benefit assessments (see table) and started 8 new procedures.
Recent changes in reimbursement prices of AMNOG products can be seen here.
A list of current EMA Positive Opinions for new drugs is available here.
Kind regards,
Dr Johannes Hankowitz and Christian Rieke
| Start Resolution | Procedure (no.) | Brand name | Indication | Additional benefit (best subpopulation) |
|---|---|---|---|---|
| Axicabtagen-Ciloleucel (3, reassessment) | Yescarta® | Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies | 100% Hint for non-quantifiable additional benefit | |
| Voxelotor | Oxbryta® | Haemolytic anaemia in sickle cell disease, monotherapy or combination with hydroxycarbamide, ≥ 12 years. | 100% Hint for non-quantifiable additional benefit | |
| Sotrovimab | Xevudy® | COVID-19, ≥ 12 years | 100% Hint for considerable additional benefit | |
| Imipenem / Cilastatin / Relebactam (2) | Recarbrio® | Bacterial infections, multiple indications | 100% additional benefit considered proven | |
| Ceftolozan / Tazobactam (6) | Zerbaxa® | Bacterial infections, multiple indications | 100% additional benefit considered proven | |
| Ceftazidim / Avibactam | Zavicefta® | Bacterial infections, multiple indications | 100% additional benefit considered proven |