Patient Access in Italy: Insights from the 2025 Time to Care & Time to Rare Reports

Throughout 2025, ProductLife Group – through its affiliate Intexo Società Benefit – continued its commitment to strengthening patient-centred healthcare systems with the Time to Care and Time to Rare report series. These quarterly analyses provide a transparent and evidence-based overview of how innovative medicines progress from European authorisation to effective availability for patients in Italy. 

As the full set of 2025 reports is now available, this article offers a consolidated view of the year’s key insights across oncology and rare diseases, highlighting the dynamics that shape timely and equitable access to care. 

Each report tracks the journey of new medicines authorised via EMA’s centralised procedure, monitoring regulatory milestones, publication in the Official Gazette of the Italian Republic (Gazzetta Ufficiale), commercial availability, and inclusion in the National Health Service (SSN). 

This systematic approach offers healthcare professionals, institutions, and industry stakeholders a reliable tool to understand emerging trends in access pathways and areas where delays or acceleration occur. 

Across 2025, rare disease therapies continued to represent one of the most dynamic clusters of innovation. The reports highlight: 

• Growing presence of ATMPs (Advanced Therapy Medicinal Products) among new orphan-designated therapies, particularly for haematological and genetic disorders. 

• Cardiovascular, metabolic, and immunological conditions remained among the most represented therapeutic areas (examples shown in the Q1 and Q4 reports). 

• For many products—including Elafibranor, Seladelpar, Sotatercept, and several gene or cell therapies—the timeline from EMA opinion to Italian SSN availability varied significantly, illustrating persistent variability in national access processes. 

• The reports reinforce the importance of clarity and transparency around price and reimbursement pathways, especially for innovative medicines addressing ultra-rare conditions. 

By providing structured comparisons quarter by quarter, Time to Rare highlights both the therapeutic progress and the challenges that remain for patients awaiting life-changing treatments. 

In oncology, 2025 saw a steady introduction of new targeted therapies and immunotherapies. The Time to Care reports reveal: 

• A continued rise in precision oncology treatments, including antibody–drug conjugates, small-molecule inhibitors and advanced cell-based approaches. 

• Variability in the time between EMA approval and national reimbursement, influenced by therapeutic class, unmet need, and negotiation complexity. 

• Increasing reliance on early engagement mechanisms, reflecting the strategic importance of oncology pathways in Italy’s access system. 

These insights help illuminate where timelines are improving and where bottlenecks persist—critical information for institutions, payers, and industry. 

A Consistent Commitment to Transparency and Patient-Centred Access 

Together, the 2025 editions of Time to Care and Time to Rare provide a comprehensive picture of how innovative therapies progress toward real-world availability for oncology and rare disease patients. 

They reaffirm PLG’s and Intexo’s commitment to supporting evidence-based, equitable, and timely access, empowering stakeholders with clear, structured, and actionable information. 

All four quarterly editions of both series are now available. 
We invite readers to explore the complete analyses and gain further insight into the evolving landscape of therapy access in Italy.