Quantifying the Dual Value and Governance Risks of Early Access Programs in Oncology: A Single-Centre Analysis and National Policy Framework

Background Early Access Programs (EAPs) and Named Patient Programs (NPPs) in Italy, governed by the Decreto Lorenzin (2017), are the primary route through which oncology patients access innovative therapies pending reimbursement by the Agenzia Italiana del Farmaco (AIFA). Their institutional value has not been systematically quantified, and key governance gaps remain formally undescribed. Methods Retrospective analysis of all EAPs and NPPs managed at AUSL Toscana Centro (Pistoia and Pescia) during 2025. Drug-cost savings were calculated from official AIFA ex-factory prices. We introduce a Dual-Value EAP Accounting Framework integrating drug-cost savings with quality-adjusted life year (QALY)-based clinical value, and compare Italian, French, and German early access governance. Results Eleven programmes covering 23 patients were active. Gross drug-cost saving from nine priced programmes was €761,728 (net ~€533,000 after 30% discount). The ribociclib adjuvant programme (EAP NATALEE; €268,721; 10 patients) was the largest contributor; QALY-based valuation adds an estimated €150,000 at €30,000/QALY. Total administrative burden was 181.7 hours (0.114 full-time equivalent [FTE]), yielding a 168:1 return on investment. Conclusions A proactively managed EAP portfolio at a single medium-sized centre generated substantial dual value. Three critical governance gaps are identified: absence of real-time AIFA portal transparency, prohibition on company-initiated programme information, and unregulated institutional incentives in intraclass settings. Five reforms — modelled on French and German governance frameworks — could address all gaps within existing AIFA regulatory mandate, without primary legislative change. The Dual-Value Framework relies on routinely available data and is directly replicable across publicly funded oncology centres. JEL codes: I11 · I13 · I18 · H51