A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.

Core reimbursement dossier

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. 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.

Core reimbursement dossiers

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 composition of such a dossier should include national specificities in terms of requirements. 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 reimbursement rate is then fixed by a decision of the national (or regional) HTA body.

Latest Glossary Definitions

Efficacy-Effectiveness Gap

The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.

Briefing Book (or briefing materials)

Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.

Clinical Impact

The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.

Commercially Confidential Information (CCI)

In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.

Clinical Evaluation Report (CER)

Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.

CE-Marking Technical File

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.

Comparative Effectiveness Research (CER)

The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat, and monitor health conditions in routine clinical practice (i.e. the real-world setting).

Core Value Dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.

Core Reimbursement Dossier

A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.

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