Clinical Trial Planning from a Payer’s Perspective
Whether in the AMNOG process for drugs or in specific reimbursement situations for diagnostics or medical devices; the clinical evidence must match the expectations and requirements of payers. In the German context, this will mainly be the focus of the statutory health insurances, in Austria and Switzerland a mix of the main association and the individual health insurance funds. Study planning must take into account the clinical trial design and, above all, the correct choice of comparative therapy and clinical endpoints. Not every clinical endpoint is actually important in the D-A-CH countries. A secondary, patient-relevant endpoint can, for example, positively influence the reimbursement decision in a well-planned study. Subgroups must also be pre-specified in order to provide the data required by payers. Furthermore, the methodological requirements for a high-quality clinical study must be followed – especially randomization and blinding, but also definitions and operationalizations as well as the timing of the measurements of endpoints.
A planned study programme can be optimized through early consultation with institutions, e.g. the Joint Federal Committee in Germany, and/or expert surveys including advisory boards. MArS can actively support you through its long-standing contacts and the MArS Payer Forum.