OBJECTIVES: Disinvesting orphan drugs with persisting clinical uncertainties after a managed entry agreement be may become inevitable to ensure an equitable healthcare ecosystem. To streamline communication of disinvestment decisions and limit public controversy, we developed a structured roadmap tailored to the Belgian context. It considers the various implications a disinvestment decision, and provides guidance for effective delivery to healthcare providers, patients and the wider public.

METHODS: We conducted a narrative review of international, peer-reviewed literature, legal and policy texts to formulate open ended questions relevant to the topic. Subsequently, we organised three focus groups with nine experts, including physicians and representatives from academia, health insurance funds, patient organisations and the Belgian drug reimbursement agency. Focus groups were transcribed verbatim and coded using Nvivo 14.

RESULTS: First of all, the reasons for disinvestment should be evidence-based and reported transparently. Furthermore, the communication strategy should be clear, pragmatic, and customized to the specific context to effectively address concerns of those impacted. It should outline the roles, responsibilities and timelines to ensure efficient execution. Collaboration among stakeholders is essential for appropriate and timely communication to patients. Additionally, Transparent communication with healthcare providers and patients throughout the managed entry agreement process can foster greater acceptance of the disinvestment decision, enhancing the roadmap’s effectiveness.

CONCLUSIONS: By employing evidence-based, transparent, collaborative, and adaptable strategies, policymakers can enhance disinvestment communication, benefiting patients and the public. While centred on disinvestment of orphan drugs in Belgium, this paper offers principles applicable to healthcare disinvestment decisions worldwide.