Impact of Ministerial Decree 77/2022 from different stakeholders' perspectives: clinicians, pharmacists, patients, and industry.

Introduction: Assess the implications of Ministerial Decree (MD) 77/2022 in Italy, which decentralizes healthcare through proximity-based models, from the perspective of key actors involved, and discuss its relevance to sustainability and value assessment. Methods: A cross-sectional survey was conducted with four stakeholder groups: pharmaceutical companies, scientific societies, Health Economics and Outcomes Research (HEOR) experts, and patient advocacy organizations (N = 162). Structured questionnaires examined awareness/knowledge, perceived implementation, perceived impact, operational feasibility, and policy alignment. Results: Over 60% of respondents recognized the strategic value of proximity care. Key barriers included administrative burden (47%), resource constraints (38%), and lack of Key Performance Indicator (KPI)-based frameworks (55%). Treatments in oncology, geriatrics, and metabolic diseases were considered most suitable for decentralized provision. Divergent perspectives emerged professional stakeholders emphasized methodological rigour and outcome monitoring, while patient organizations foregrounded equity of access, responsiveness, and patient-facing feasibility. Conclusion: MD 77/2022 opens a policy window to align decentralized care pathways with sustainability and value assessment. However, the survey did not collect empirical pricing, reimbursement, or cost-effectiveness data; therefore, any implications for pricing governance should be interpreted as conceptual and hypothesis-generating rather than as demonstrated effects. Heterogeneous implementation and fragmented outcome measurement remain the primary barriers; a minimum viable KPI set and routine data infrastructure are prerequisites for translating perceived value into decision-relevant evidence.