Navigating market access after conditional reimbursement : a communication roadmap for disinvesting orphan drugs

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Abdallah, Khadidja and Blonda, Alessandra and Godman, Brian and Huys, Isabelle and Claes, Kathleen and Denier, Yvonne and Simoens, Steven (2026) Navigating market access after conditional reimbursement : a communication roadmap for disinvesting orphan drugs. International Journal of Technology Assessment in Health Care. ISSN 1471-6348 (In Press) (https://doi.org/10.1017/S0266462326103444)

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Abstract

Introduction: Disinvesting from rare disease therapies with persistent clinical uncertainties after a managed entry agreement, may be necessary to ensure an equitable and sustainable healthcare ecosystem. To minimise public controversy, communication about these disinvestment decisions must be timely, transparent, and tailored to the needs of stakeholders. This study develops a structured communication roadmap tailored to the Belgian context. Special consideration is given to the various implications of a disinvestment decision, with attention to the clinical, financial, ethical, psychological, and social implications of disinvestment. Methods: Three advisory board meetings were held with nine experts from academia, clinical practice, health insurance funds, patient organisations, and the Belgian Drug Reimbursement Committee. A targeted review of peer-reviewed literature, legal texts and policy documents informed the meeting guide. Meetings were transcribed verbatim and analysed using Nvivo 14 following grounded theory principles. Results: Disinvestment should be grounded in evidence and communicated clearly, pragmatically, and in a context-specific manner. The proposed five-step roadmap outlines the roles, responsibilities, and timelines for key stakeholders. It also provides guidance for public documents such as a lay summary of the health technology reassessment report and letters intended for patients and the public. Collaboration among stakeholders is essential for appropriate and timely communication to patients. Additionally, frequent touchpoints with healthcare providers and patients throughout the managed entry agreement process can foster greater acceptance of the final decision. Conclusion: By employing evidence-based, transparent, collaborative, and adaptable strategies, policymakers can improve the delivery of disinvestment decisions and maintain trust among patients and the public. While developed for rare disease therapies in Belgium, the principles and roadmap are transferable to other disinvestment decisions internationally.

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