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Resolutions May 2022
| Start Resolution | Procedure (no.) | Brand name | Indication | Additional benefit (best subgroup) |
|---|---|---|---|---|
| Cefiderocol (2) | Fetcroja® | Infections caused by aerobic gram-negative pathogens | 100% additional benefit considered proven | |
| Delamanid (2) | Deltyba® | Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg | 100% Hint for non-quantifiable additional benefit | |
| Elbasvir / Grazoprevir (2) | Zepatier® | Chronic hepatitis C (HCV), 12 to < 18 years | 100% no additional benefit | |
| Pembrolizumab (18) | Keytruda® | Carcinoma of the esophagus or gastroesophageal junction, PD-L1 expression ≥ 10 (CPS), first-line, combination with platinum- and fluoropyrimidine-based chemotherapy. | 34% Indication of considerable additional benefit | |
| Pembrolizumab (17) | Keytruda® | Mammary carcinoma (BC), triple-negative, PD-L1 expression ≥ 10 (CPS), combination with chemotherapy | 50% Hint for considerable additional benefit |
Dear AMNOG Monitor readers,
The draft of the GKV-Financial Stabilisation Act (GKV-FinStG) provides for massive savings on medicines in order to limit the expected increases in expenditure in the statutory health insurance system:
- Free pricing for innovative medicines with AMNOG procedures is to be shortened to six months.
- The manufacturer's discount, in particular for patent-protected medicines according to § 130a para. 1, is to be increased in a staggered manner as follows: 01.01.2023: 19%; 01.01.2024: 16%, 01.01.2025: 13%, 01.01.2026: 10%
- For newly introduced, innovative medicinal products, a price reduction of 15% for combination products is to be introduced.
- The price moratorium is to be extended until 31.12.2026.
- Discarding due to uneconomical package sizes is to be reflected in the negotiated price in the form of a discount.
- Quantity-related aspects, such as a quantity-related graduation or an annual total volume, are to become a mandatory part of the price negotiations according to § 130b SGB V.
- The annual turnover threshold for the loss of orphan drug privileges in the AMNOG procedure is to be reduced from €50m to €20m.
- The pharmacy discount is to be increased to €2.00 for a period of two years.
- VAT is to be reduced to 7% for medicines from 2023 (as part of a separate law).
From May 2022 we add further innovations to the Interactive Analysis in the AMNOG Monitor, which until further notice will be available to you free of charge:
- Revised interactive analysis for better overview and user-friendliness.
- “G-BA endpoints (AIS)”: Summary of relevant clinical endpoints in the categories mortality, morbidity, quality of life and adverse drug reaction according to the Physician Information System (AIS) / G-BA resolution.
- “G-BA endpoints (AIS↑↓)”: Direction of effect and reliability of the endpoint categories mortality, morbidity, quality of life and adverse reaction with arrow display
- “Regulatory ICD-10 categories” Three-digit ICD codes such as "I21 - Acute myocardial infarction"
- G-BA criterion "Relevant therapy option in individual cases" for the exception rule according to AM-VSG.
- Reason for the procedure (special feature): Filter option for special constellations, e.g. known active substances with new dossier protection, reserve antibiotics, exceeding the de minimis limit, etc.
- “Pharmaceutical company” and “Dossier: Pharmaceutical company”: Representation of the current MAH and the dossier submitter, so that acquisitions after the G-BA resolution can be easily tracked.
The G-BA has so far provided results on the AIS for approx. 70% of the subpopulations. For repealed G-BA resolutions there will be no subsequent assessment in the AIS.
In April, there were 5 new G-BA resolutions on early benefit assessments, the results of which are shown in the table below. The exemption for the reserve antibiotic Eravacyclin has not yet been included by the G-BA in the list of decisions.
Recent changes in reimbursement prices of AMNOG products in November 2021 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 subgroup) |
|---|---|---|---|---|
| Ixazomib (2, reassessment) | Ninlaro® | Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone | 100% Hint for non-quantifiable additional benefit | |
| Pitolisant (2, Ozawade®) | Ozawade® | Daytime sleepiness in obstructive sleep apnea, after previous therapy | 100% no additional benefit | |
| Sofosbuvir / Velpatasvir / Voxilaprevir (2) | Vosevi® | Chronic hepatitis C (HCV), 12 to < 18 years | 100% no additional benefit | |
| Albutrepenonacog alfa (2, reassessment >€50m) | Idelvion® | Hemophilia B, congenital factor IX deficiency | 100% no additional benefit | |
| Erdnussprotein als entfettetes Pulver von Arachis hypogaea L., semen (Erdnüsse) | Palforzia® | Peanut allergy, ≥ 4 years | 100% no additional benefit |