Drivers of managed entry agreements to reduce reimbursement challenges of orphan medicinal products: the development of a matrix.

ABSTRACT:

Background

Reimbursing orphan medicinal products (OMPs) presents both opportunities and challenges for national healthcare payers and health technology assessment (HTA) bodies because of their potential high benefits, large clinical uncertainties and high prices. To support a more structured application of (outcome-based) managed entry agreements (MEAs) intended to mitigate these OMP-related reimbursement challenges, a matrix was developed to facilitate reimbursement negotiations and, ultimately, patient access.

Methods

A systematic literature review was performed, searching PubMed, Embase, and grey literature from 1 January 2000 until 1 January 2024 to globally identify reimbursement challenges (clinical-, cost-effectiveness uncertainties, or financial risks) described in r

SUBMITTER: Callenbach MHE 

PROVIDER: S-EPMC12560585 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature