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.
 

List of all G-BA Resolutions

The AMNOG monitor includes detailed analyses of every sinlge benefit assessment since 2011. more >>

Interactive Analysis

Our comprehensive online analysis tool helps answer your individual questions. more >>

Intelligent search

Search for answers in all G-BA resolutions, justifications, IQWiG assessments and much more >>

Reimbursement Price Trends

See the development of manufacturer's prices and yearly therapy costs of all products with negotiated reimbursement prices. more >>

Unrivalled AMNOG Process Knowledge

Gain relevant insights from our summary analysis and our evaluation of all AMNOG resolutions. more >>

 

 

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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.

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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Dear AMNOG Monitor readers,

The German Health Insurance Financial Stabilization Act (GKV-Finanzstabilisierungsgesetz; GKV-FinStG), which is to be finalized at the end of October, is currently going through the readings in the Bundestag. The draft bill has met with criticism even from the coalition partners, Greens and FDP, so that changes are to be expected. For the potential impact of the act on the AMNOG process, please refer to the vfa's statement.

In September, we added several innovations to the AMNOG Monitor:

Detailed analyses: Price history

  • In the graphs and tables of the package and annual therapy costs, negotiation results in percentage points are now shown for all AMNOG negotiations of the product in addition to the results of the respective procedure.
  • The tables clearly show the start and end of the reimbursement amount negotiation of the respective procedure.
  • In the price history graphs, you can now choose between "since launch", "since 2021" or "negotiation period". You can also freely select time periods to conveniently compare the price histories of different products.

Interactive analyses

  • Our new Interactive Analysis "All Procedures" provides an overview of all ongoing, completed, suspended, discontinued and exempted procedures in the early benefit assessment.
  • We have created 5 categories that of dimensions that you can show or hide as needed:
    • Main parameters such as active substance, date, reason for procedure, indication and additional benefit
    • Dossier: data submitted by the manufacturer such as endpoints and additional benefit claim
    • G-BA/IQWiG: Data that G-BA or IQWiG have determined:           
      new: Special evaluation criteria of the G-BA, which lead to the up- or downgrading of the added benefit.
      new: new assessment algorithm for categorization of study design
    • Price criteria
    • Regulatory criteria

The definitions of all parameters can befound by clicking on the "All dimensions are documented here" link.

In total, there were 12 G-BA resolution on early benefit assessment in September 2022 (see table).

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)
Avapritinib (2) Ayvakyt® Leukaemia, myeloid, acute (AML); mastocytosis; after at least 1 previous therapy 100% Hint for non-quantifiable additional benefit
Somatrogon Ngenla® Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age 100% Hint for non-quantifiable additional benefit
Dolutegravir (4, reassessment) Tivicay® HIV infection, age 6 to < 18 years resolution w/o assessement
Voretigen Neparvovec (2, reassessment) Luxturna® Hereditary retinal dystrophy 100% Hint for considerable additional benefit
Pegcetacoplan Aspaveli® Paroxysmal nocturnal haemoglobinuria (PNH), pre-treated patients 100% Hint for non-quantifiable additional benefit
Idebenon (2, reassessment) Raxone® Leber's hereditary optic neuropathy (LHOP) 100% Hint for non-quantifiable additional benefit
Empagliflozin (4) Jardiance® Chronic heart failure (CHF) with preserved ejection fraction 100% Hint for minor additional benefit
Daratumumab (9, reassessment) Darzalex® Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone 100% Proof of considerable additional benefit
Brivaracetam (3) Briviact® Focal seizures in epilepsy, additional therapy, 2 to < 4 years 100% no additional benefit
Lorlatinib (2) Lorviqua® Non-small cell lung cancer (NSCLC), ALK+, first-line 100% no additional benefit
Tepotinib Tepmetko® Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients 100% no additional benefit
Vedolizumab (2) Entyvio® Antibiotic-refractory pouchitis, pre-treated patients 100% no additional benefit