Early Dialogue Framework & European HTA
Trial sponsors face the challenge of designing studies that will satisfy the requirements of the different, local registration authorities, as well as those of the various national HTA (Health Technology Assessment) agencies.
We can help your company keep on top of changes in the European HTA landscape through our extensive experience with EUnet HTA and EMA. This includes support and services for the Early Dialogue framework, a standardized, transparent assessment process which has been established by the European Commission and is supported by EUnet HTA.
Our services with regards to Early Dialogue include:
Identification of topics and formulation of questions for EMA and HTA agencies
Compilation of briefing documents for EMA-EUnetHTA Parallel Consultation and EUnetHTA multi-HTA Early Dialogue
Strategic consulting in choosing the right HTA process and in the identification of relevant contacts
Our services with regard to European HTA include:
Preparation of submission files and support throughout the European HTA process
Systematic searches of literature databases and study registries
Analyses of epidemiological data
Direct and indirect treatment comparisons and (network) meta-analyses
Vast expertise in statistical methodologies including frequentist and Bayesian approaches
Health economic evaluations (e.g. cost effectiveness analyses, budget impact analyses)
Market Access
In a continuously changing market, market access is a complex, dynamic process. Strategies for successful market access require early planning and ideally begin early in the development phase. The key to success is a benefit-driven rationale for adding value to your product, to showcase its innovation character in an optimal way, and to positively impact pricing throughout the process.
Use our expertise and our continuous professional exchange with authorities and associations for a successful market access strategy. Openly and sensitively, we anticipate the input of all process participants and integrate changing requirements into process planning. We focus on the essentials - for an effective price negotiation and the best possible reimbursement amount.
Our services include:
Support for national and European early counseling sessions
Joint development of a targeted dossier strategy with early risk assessment and exploration of the room for maneuvering to benefit rationale
Carrying out economic evaluations (e.g., cost-benefit analysis, budget impact analysis)
Assistance with a target group oriented and precise transfer of the added value within the scope of different stakeholders
Advice on pricing and reimbursement issues and preparatory and active participation in price negotiations
Early Benefit Assessment: AMNOG
The successful placement of your product on the market is significantly influenced by the professional implementation of all components of the early benefit assessment according to the German Pharmaceutical Market Reorganization Act (AMNOG). The way to the additional benefit of your drug compared to the standard therapy leads you through the field of tension of IQWiG, G-BA and the GKV-Spitzenverband.
Launched as pioneers in 2010, today, we are one of the market leaders in the field of early benefit assessment. We are currently looking forward to a successful collaboration with nine of the ten leading pharmaceutical companies and have a high market share. With our proven expertise, we master any challenges for you and competently guide you through the entire process of early benefit assessment. From the G-BA consultancy through the creation of the benefit dossier and the commenting process to the price negotiation, we focus on the goal of adequately communicating the added value of your product and achieving optimal market acceptance.
Our services include:
G-BA Consultation on the study design or submission of dossiers
Creation of all modules of the user dossier
Carrying out the required information gathering on the basis of systematic literature searches and search register searches
Programming of additional statistical analysis required for submission in the dossier
Support in the written opinion and the oral hearing
Application of alternative statistical methods (including benefit-risk methodology, propensity score-based methods)
We specialize in a variety of services and solutions.
