Advanced therapies, Italy is at 15 but will double by 2027
In seen an expenditure of 800 million for the health service over the next five years, but the issue of equity of access remains, with Lombardy and Emilia-Romagna now leaders in the number of treatments started, while Sicily shows the greatest growth
Key points
Sono15 the advanced therapies approved and reimbursed in Italy and another 13 will arrive by 2027, with an expenditure borne by the National Health Service that could quadruple in the next five years, reaching about 800 million euros. We are talking about DNA or RNA gene therapies, cellular and tissue therapies particularly targeted on rare diseases as well as on oncological pathologies, but not only.
The 8th Italian Report on ART, Advanced Therapy Medicinal Products, realised by Atmp Forum, a virtual agora founded in 2017 with the aim of stimulating interaction and discussion among the stakeholders of the Health System on progress, clinical, economic and organisational issues related to ART, is outlining the balance and future prospects.
The European Landscape
Il Report ha tracciato un quadro aggiornato di Atmp approvati e disponibili a livello europeo che rispetto al 2024 conta 3 nuovi “prodotti”: 2 terapie geniche e 1 terapia cellulare. La quota di Atmp rimborsati rimane ancora molto diversa da Paese a Paese: nel 2025 la Germania si conferma il Paese con il maggior numero di Atmp attualmente disponibili sul mercato (17) mentre la Spagna è fanalino di coda, con solo 8 Atmp rimborsati. Queste disparità tra Paesi europei nell’accesso alle terapie avanzate riflettono non solo differenze regolatorie, ma anche priorità nazionali, capacità di investimento e modelli di governance sanitaria.
«L’ottavo report sulle terapie avanzate si conferma come documento di riferimento per tutti coloro che si occupano di Atmp in Italia e offre, inoltre, uno sguardo su come altri paesi europei stanno affrontando questo capitolo della medicina - afferma Fulvio Luccini, Managing Director Market Access & Reimbursement, Cencora Pharmalex Italy e membro del Comitato Diret
The Italy scenario
At the regional level, advanced therapies show a heterogeneous distribution: the least populous regions, together with Trentino-Alto Adige and Sardinia, do not record any treatments. Lombardy confirms its leadership in terms of number of treatments and expenditure, with an increase of 82% compared to 2023. It is followed by Latium and Veneto in terms of expenditure, while Emilia-Romagna, Sicily and Piedmont stand out in terms of number of treatments. Particularly significant is the growth in the South: Sicily, Apulia and Campania have more than doubled their expenditure, driving a general doubling of treatments and investments in the South and Insular area, despite a per capita expenditure that is still below the national average.
The challenge of equitable access
"In order to guarantee equal access to OTMs throughout Italy, it is essential to start coordination and advance planning activities, also at supra-regional level, already in the preliminary stages of the regulatory pathway,' says Claudio Jommi, professor of Business Economics at the Avogadro University of Eastern Piedmont and member of the OTMP Steering Committee. 'The OTMP Italian Multi-Regional Network project has developed concrete tools to support the regions in identifying operational solutions; thanks to the forecast of OTMs coming in the next two years, it will be possible to tackle the main complexities related to access in advance: from epidemiological estimates to the organisational management of supply centres, and even patient mobility on a supra-regional scale.
The Sustainability Challenge
On the economic-financial sustainability front, although current spending on MPPAs is still low, it is expected to increase significantly in the coming years. With this in mind, the last chapter of the Report gives space to the proposals that emerged during the MPPA Sustainability Hackathon, a participatory initiative that involved experts and stakeholders in the definition of concrete solutions. The proposals aim to promote flexible models, consistent with regulatory and management constraints, capable of incentivising innovation, guaranteeing equal access and sustaining sustainability over time.
