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

OBJECTIVES: Disinvesting from rare disease therapies with persistent clinical uncertainties following a managed entry agreement (MEA) may be necessary to ensure an equitable and sustainable healthcare system. To minimize public controversy, communication surrounding such disinvestment decisions must be timely, transparent, and tailored to stakeholder needs. This study develops a structured communication roadmap for disinvestment decisions in the Belgian context, addressing the clinical, financial, ethical, psychological, and social implications. METHODS: Three advisory board meetings were conducted with nine experts from academia, clinical practice, health insurance funds, patient organizations, and the Belgian Drug Reimbursement Committee. A targeted review of peer-reviewed literature, legal texts, and policy documents informed the discussion guide. Meetings were transcribed verbatim and analyzed using NVivo 14, following grounded theory principles. RESULTS: Disinvestment decisions should be evidence-based and communicated clearly and pragmatically in a context-specific manner. The proposed five-step roadmap defines the roles, responsibilities, and timelines of key stakeholders and provides guidance for public-facing documents, including a lay summary of the health technology reassessment report and written communications for patients and the public. Effective and timely communication with patients requires close collaboration among stakeholders. Moreover, regular engagement with healthcare providers and patients throughout the MEA period can enhance understanding and acceptance of the final decision. CONCLUSIONS: Transparent, collaborative, and adaptable communication strategies can facilitate the implementation of disinvestment decisions and help maintain trust among patients and the public. Although developed for rare disease therapies in Belgium, the proposed principles and roadmap are applicable to disinvestment processes in other healthcare systems.