In general, clinical studies are the basis of the early benefit assessment according to AMNOG. For medicinal products, randomised controlled trials are considered the gold standard for Health Technology Assessments in Germany. Further important criteria are defined by the relevant authorities, the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG). Most importantly, these include the determination of an appropriate comparative therapy and the consideration of patient-relevant endpoints in the respective indication.
Thus, the clinical trial design is not only important for the market authorization but also for market access and reimbursement of new drugs and medical devices. We are offering consultancy service with respect to clinical trial planning in terms of optimal market access and reimbursement. Based on systematic literature research, we examine potential comparators and clinical endpoints in terms of the requirements of the benefit assement.
We support you in the strategic preparation of and application for G-BA scientic advice meetings in order to achieve an optimal market access.