What does an AMNOG dossier look like?
At the heart of the benefit dossier is a detailed statistical presentation, in particular of randomized studies, comparing the benefit of the new medicinal product with that of the appropriate comparator treatment. In nearly half of all cases, two or more patient populations need to be differentiated and analysed separately. These populations will often require different comparator treatments.
The focus of the analyses is on patient-relevant outcomes in the areas of mortality, morbidity, safety and quality of life. Patient-reported outcomes (PRO) play an important role here. Similar to adverse events, they must be presented in a level of detail that usually exceeds that of the clinical study reports. In addition, comprehensive subgroup analyses must be performed for all outcomes. For international studies these should include proof of the transferability of the results to Germany.
The AMNOG procedure step by step
As well as compiling the AMNOG dossier, the Institute for Evidence-Based Positioning in the Healthcare Sector offers other services related to the AMNOG procedure. These include strategic consulting from the perspective of the payer and preparation for hearings and negotiations.
Services in detail
AMNOG dossier creation – benefiting from many years of experience
Professor Dietrich was for many years a deputy member of the decision-making body of the German Federal Joint Committee (G-BA) and was responsible for controlling national pharmaceutical expenditure at the German National Association of Statutory Health Insurance Physicians (KBV).
In the course of her consulting activities she has created a great number of AMNOG dossiers and has supported and advised pharmaceutical companies in hundreds of projects.
Her experience covers ophthalmology, infectious diseases, oncology, dermatology; respiratory, cardiovascular and metabolic diseases; disorders of the musculoskeletal, urogenital, digestive and nervous systems; and haematological diseases.