AMNOG BENEFIT ASSESSMENT

This page compiles information on the benefit assessment of pharmaceuticals in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG - German Social Code, SGB V §35a).

With the AMNOG BENEFIT ASSESSMENT analysis advisors in healthcare has developed a tool showing the outcomes of the early benefit assessment of new innovative drugs in Germany at one glance. With the monthly analyzed outcomes of all conducted and published early benefit assessments, we enable our pharma clients to improve their Market Access and Reimbursement planning.

ANALYSIS 1: Drugs without orphan designation

 

 

We analyze and compare the additional benefit that was recommended by the Institute for Quality and Efficiency in Health Care (IQWiG) and finally assessed by the Federal Joint Committee (G-BA) with the expectations of the manufacturers according to the value dossier. The analysis is based on subpopulations and does not include orphan drugs.

ANALYSIS 2: Orphan Drugs

 

 

Orphan drugs have a special status in the early benefit assessment as their additional benefit is granted by marketing authorization of the EMA (SGB V, §35a, paragraph 1, sentence 10). As a consequence, the G-BA does not require a scientific assessment by the IQWiG.

Therefore we developed a separate overview showing the additional benefits of orphan drugs, which is also based on subpopulations.

 

ANALYSIS 3: Therapeutic Areas

This section contains analyses of different therapeutic areas as defined by the Federal Joint Committee (G-BA): Blood and blood forming organs, cardiovascular, digestive system, eye, genitourinary, infectious, mental, metabolic, musculo-skeletal, nervous system, oncological, respiratory, skin and others.

The analyses are based on subpopulations and include non-orphan as well as orphan drugs.

You can request a download of the entire analysis free of charge.