The reimbursement rate is then fixed by a decision of the national (or regional) HTA body. Examples such as the innovativeness of the product, the proof of therapeutic benefits in a given population, an improved quality of life or the severity of the disease may be taken into consideration during its review. The composition of such a dossier should include national specificities in terms of requirements. The reimbursement dossier is part of the core value dossier: it is a comprehensive information resource which presents all supporting evidence of the clinical, economic, and humanistic value for a new intervention as well as the global burden of illness for that particular therapeutic area.

The dossier compiles evidence about healthcare interventions to support submissions to HTA agencies, as well as national and local payers.This document is critical to achieve the consistency and substantiation of key scientific and commercial messages. The submission of a reimbursement dossier, as part of the core value dossier, is required for any registered medicinal product or certified medical devices to be considered for reimbursement. Please note: Technical documentation/Design Dossiers that accurately conform to the below guidance can be reviewed more efficiently In this regard it is recommended to compile a Design Dossier or technical file as follows (see also NB-MED/2.5.1 and GHTF document SG1 (PD)/N011R20: STED).

Chemistry, Manufacturing & Controls (CMC)Ī core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.

Clinical Investigations for Medical Devices and Digital Healthcare Products.

Biometry: Clinical Data Management & Statistics.

Clinical Development Planning & Strategy.

Immune System, Connective Tissue, Bone and Joint Disorders.

Design dossier definition