Amnog price negotiations

Various institutionalised consultations, hearings and price negotiations take place in connection with the benefit assessment which require the best possible and targeted preparation on the part of the pharmaceutical company. In this respect, it is important to understand the respective context and to be best prepared for the situation in terms of content. Our training offer covers the following aspects:

targeted and specific preparation for the G-BA consultation meeting in preparation for the AMNOG benefit assessment,
practical preparation for the oral hearing associated with each AMNOG procedure,
as well as specific training/coaching on the price negotiations.

Based on our expertise in content and our practical experience, we prepare you for discussions with the G-BA and the GKV-SV in the best possible way. Benefit from our experience!

G-BA Consultation

In the consultation meeting at the G-BA, it is mainly the appropriate comparator therapy for a new medicinal product that is determined. In addition, questions regarding the study design and the endpoints of a study may be addressed. The G-BA consultation is based on a written request by the pharmaceutical company which is processed by the Pharmaceuticals Subcommittee of the G-BA. In addition, an oral consultation with the G-BA is conducted in order to answer and discuss the questions submitted by the pharmaceutical company. Our services include the preparation of the written G-BA consultation request according to methods of evidence-based medicine as well as the preparation of the content and training for the consultation meeting with the G-BA.

G-BA Hearing

The early benefit assessment process provides for a hearing phase following the benefit assessment. The hearing consists of a written statement and an oral hearing before the G-BA. In the written statement, the results of the benefit assessment can be commented on and discussed and, if necessary, further data can be submitted. The statement period is 3 weeks after publication of the benefit assessment. This is followed by an additional oral hearing before the G-BA where further questions can be discussed whilst also involving the expert groups and associations of the pharmaceutical industry. Due to its structure and process, the oral hearing represents a special challenge which requires specific preparation.

Our services include the preparation of the written statement based on the results of the IQWiG / G-BA benefit assessment as well as specific training, practical exercises and simulations to prepare for the oral hearing.

Price Negotiations for the Reimbursement Amount

The aim of the early benefit assessment according to AMNOG is to negotiate a reimbursement amount for new medicinal products. While the benefit assessment is carried out by the G-BA and IQWiG, the price negotiations according to §130b SGB V are organised and conducted by the GKV-Spitzenverband.

Appropriate preparation for the reimbursement negotiations is a prerequisite for a good outcome. This includes the market and price analysis of the comparable medicinal products, the epidemiological data and supply shares, the consideration of the European reference prices and the evidence-based assessment of the medicinal products in the indication. Benefit from our experience and expertise from many price negotiations.

In our specific trainings, we prepare you for price negotiations on the reimbursement amount by together developing goals, strategies and tactics and simulating the negotiations with you.

AMNOG Trainings

Our training programme on early benefit assessment according to AMNOG covers the presentation of the legal, regulatory and methodological framework conditions, the structure of the individual modules of the dossier as well as the critical aspects in the preparation of AMNOG dossiers. At the same time, we offer an introduction to systematic searches in bibliographic databases and study registries as one of the prerequisites for the preparation of AMNOG dossiers. The programme is supplemented by a statistics module as a basis for the assessment of clinical studies in the context of the early benefit assessment.

We will be happy to arrange an individual training course to suit your specific needs.