The successful launch of your product to the German market is heavily dependent on a professional and successful execution of all components of the benefit assessment process. The demonstration of the added benefit of your drug versus a standard comparator therapy lies at the heart of the process involving the German HTA agency Institute for Quality and Efficiency in Health Care (IQWiG), the Federal Joint Committee (G-BA) as the authority responsible for the assessment, and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) – parties which often have diverging interests.
Starting out as pioneers in 2010, AMS has become one of the leading service providers in the field of Early Benefit Assessment. To date, we have worked successfully with 9 of the 10 largest pharmaceutical companies and cover a respectively high market share. Our proven expertise allows us to accept all challenges and will guide you throughout the complete process of Early Benefit Assessment. From the early advice request and through the benefit dossier, the hearing procedure through to price negotiations with the payers, we focus on providing the best possible communication strategies to demonstrate the value of your product and gain optimal acceptance in the German market.
- Preparation of sessions for early request for consultation regarding study design or inquiries pre-benefit dossier submission
- Preparation of all modules of the benefit dossier
- Systematic literature searches and searches of study registries according to the provisions of the German AMNOG law and regulations
- Preparation and interpretation of adjusted indirect treatment comparisons and (network) meta-analyses
- Support with the preparations for the Written Statement and Oral Hearing with the G-BA
- Implementation of alternative biostatistical methodologies (e.g. benefit-risk methodology, propensity score-based methods)
- In evidence-based benefit assessments, the focus is on a detailed presentation of the results of individual patient-relevant endpoints. These analyses usually go beyond of what is required and prespecified in approval studies.
For example, in case of more than one study, results need to be presented by meta-analysis.
Furthermore, subgroup effects have to be analysed and presented for all endpoints.
In many cases, time-to-event analyses are the only adequate and accepted form of evaluation.
Finally, an adjusted indirect comparison has to be conducted if no direct evaluation (head-to-head study) to the appropriate comparator is available.
AMS provides you with all statistical analyses required for submission of the dossier and supports you in the communication with your company statisticians (e.g. formulation of data requests).