Presentation (CTI)

OBJECTIVES: ATMPs often hold transformative potential for patients with high unmet clinical needs, yet their real-world impact is frequently constrained by layered financial, organizational, and managerial complexities that extend well beyond market authorization and reimbursement. In Italy, structural barriers translate into a median 7-month delay between Pricing and Reimbursement publication and first product dispensation, with substantial interregional heterogeneity. Proactive regional planning is essential to anticipate resource gaps, define care networks, and ensure equitable access. This study illustrates a multidimensional framework designed to guide regional readiness assessment and strategic planning for ATMPs.
METHODS: A sequential focus group methodology was employed, convening a purposively selected multidisciplinary panel — spanning regional planning, hospital pharmacy, clinical practice, healthcare management, academia, and industry. Four thematic domains were explored through dedicated sessions, each targeting a distinct dimension of ATMPs planning complexity. Findings were consolidated and iteratively validated through thematic analysis, ensuring cross-domain coherence and stakeholder agreement.
RESULTS: The framework encompasses four macro-domains of complexity: (i) epidemiology — quality and evolution of epidemiological data, source reliability, eligibility criteria definition, and alignment between patient estimates and prescribing centres; (ii) organizational impact — local (multidisciplinary teams, qualification standards, technological infrastructure, data management), regional (network configurations, including Hub and Spokes model, integrated care pathways), and extra-regional (patient mobility); (iii) managerial and financial planning — budget impact at regional and local levels, coding and tariff availability, Innovative Drug Fund governance, procurement processes, and contractual frameworks; (iv) accessibility to care — treatment centre selection, network coordination, pathway-specific training, patient and caregiver engagement, patient advocacy group involvement, and equity of access at national-level.
CONCLUSIONS: By systematizing ATMPs-specific complexities into an actionable planning framework, this work provides healthcare system planners with a replicable tool to assess regional preparedness, prioritize interventions, and reduce access inequities — ultimately supporting timelier and more sustainable ATMPs integration into clinical care.