Sustainability of Advanced Therapies in Italy

Dicembre 2023

by Rosanna Sovani Partner LS CUBE and Eugenio Di Brino Researcher ALTEMS

Advanced Therapy Medicinal Products (or ‘ATMPs’), including gene therapies, cell therapies, and tissue therapies, offer a promising avenue for treating severe diseases without any therapeutical alternative all around the world. However, the integration of these innovative treatments into the Italian healthcare system
presents multifaceted challenges, particularly in terms of financial sustainability.
Ensuring the sustainability of advanced therapies in Italy requires a strategic approach that combines innovative annuity payment models, performance-based
agreements, and a clear focus on the longterm benefits for patients and the healthcare system. By framing these expenditures as investments and implementing forwardlooking financial strategies, Italy can be a pilot in the EU NHS by navigating the challenges posed by advanced therapies while providing cutting-edge care to its citizens. The volume of resources required to access these therapies and the way they are funded will be decisive in the future, because they will determine the extent to which healthcare systems are willing to bear their costs.


During the event La valutazione della spesa per le Terapie Avanzate (ATMPs) that will take place in 2023, December 13 at the Università Cattolica in Rome addressing the Sustainability of the ATMP, the Postgraduate School of Health Economics and Management (ALTEMS) of the Università Cattolica del Sacro Cuore in cooperation with LS CUBE shall present an academic study aimed at deepening the ATMP economic and clinical characteristics requiring a change of paradigm based on three main pillars.
First, challenges sustainability. High Upfront Costs: Advanced therapies often come with substantial upfront costs, which can strain healthcare budgets. These therapies require specialized infrastructure, skilled personnel, and expensive manufacturing processes. Small Patient Populations: Some
advanced therapies target rare diseases, resulting in small patient populations. The limited number of eligible patients can make it challenging to distribute the costs effectively. Long-Term Follow-Up: Monitoring and ensuring the long-term effectiveness and safety of advanced therapies require ongoing investments in patient follow- up, data collection, and healthcare infrastructure.
Second, Payment Models for Sustainability.
Annuity payment models involve spreading the cost of a treatment over several years, making it a viable option for addressing the sustainability of advanced therapies in Italy.

Multi-Year Budget Allocations:
Italian healthcare authorities could allocate budgets for advanced therapies over multiple years, ensuring a more predictable financial commitment. This approach mitigates the immediate impact on annual budgets and facilitates long-term planning.
Performance-Based Payments: Payments for advanced therapies can be linked to performance metrics. If patients achieve predefined health outcomes, the healthcare system continues to fund the treatment.
This approach ensures that resources are allocated efficiently and only to treatments that demonstrate clinical benefits. Risk- Sharing Agreements: Collaborative agreements between healthcare providers, manufacturers, and payers can include provisions for annuity payments. These agreements may involve tiered payments based on the therapy’s success in delivering anticipated outcomes. Public Healthcare Investment Funds: Establishing dedicated public healthcare investment funds can help finance advanced therapies over an extended period. These funds can be replenished annually, spreading the financial burden.
Third, qualifying Expenditure as Investment. To help garner support for innovative annuity payment models, it is essential to frame the expenditure on advanced therapies as an investment in the long-term health and well-being of patients and the healthcare system. In particular: conducting comprehensive economic impact assessments can quantify the long-term benefits of advanced therapies, such as reduced hospitalizations, increased productivity, and improved quality of life. Demonstrating the return on investment is crucial. Transparent reporting of both the costs and outcomes associated with advanced therapies is vital, regular evaluations of the therapies’ performance can provide evidence of their value and sustainability. Finally, engaging patients in shared decision-making and understanding their perspectives on the value of advanced therapies can further justify the investment.
During the event, a paper resulting from the research project “Evaluation of expenditure on advanced therapy medicinal products” (ALTEMS, 2023) will be presented in which the authors suggests as a solution applying these accounting criteria within the framework of a specific multi-year expenditure authorisation, by setting up an ad hoc fund for ATMPs with the aforesaid accounting characteristics. Such a Fund could make provision for the allocation of determined sums (thus satisfying expenditure planning and monitoring requirements) and allow for a more appropriate evaluation of the distribution of benefits on a multiyear level within the framework of a controlled management of the expenditure.
At the following link you can find the publication: https://altems.unicatt.it/altems-health-economics-la-valutazione-della-spesa-per-le-terapie-avanzate.

Torna in alto