Advanced therapies, a dedicated fund is needed to pay for them

Advanced therapies, a dedicated fund is needed to pay for them


A dedicated fund, i.e. money set aside to finance the most innovative therapies, i.e. those biological medicines that contain genetic material or stem cells subjected to a biotechnological process carried out in highly specialized laboratories. And a way to account for this money different from the current one, i.e. the one used for more traditional drugs, which allows the payment of therapies to be paid in installments, enhancing the investment element for the system as a whole. These are the two elements of the proposal that emerged from a study, unique in Italy and Europe, on the evaluation of spending on advanced therapies, conducted by the High School of Economics and Management of Health Systems (ALTEMS) – Faculty of Economics of the Catholic University , in collaboration with LS Cube Studio Legale.

An urgent need

It is estimated that, between now and 2030, there will be over 500,000 patients globally who will be treated with advanced therapies. These are expensive treatments, each of which costs between 1 and 3 million euros, which will therefore have a significant impact on the spending of the National Health Service. Hence the need to rethink the accounting system for these healthcare expenses so as to fully seize the opportunities that this therapeutic revolution offers to patients. To explain how this can be done, a study was conducted which, for the first time, carried out an economic and accounting analysis of advanced therapies, outlining their distinctive and unique features compared to traditional drugs.

A choral work

Established in 2020, the Working Group that has contributed over the years to the elaboration and updating of this work, coordinated by LS CUBE, saw the participation of Giorgio Alleva, Professor of Statistics at the University of Rome, La Sapienza, of Paolo Gasparini, Clinical Coordinator at the Committee for Advanced Therapies (CAT) of the European Medicine Agency (EMA), by Mauro Marè, Full Professor of Finance at the University of Tuscia and the Luiss Business School, by Eugenio Anessi Pessina, Full Professor of Business Economics at the Catholic University and of the lawyer Rosanna Sovani, Partner of LS CUBE Law Firm. The group was attended by Americo Cicchetti, Professor of Business Organization at the Catholic University of Rome, currently General Director of health planning at the Ministry of Health.

The proposal

The proposal that concludes the document is to set up on an experimental basis a fund dedicated to advanced therapies with different accounting that allows the payment of therapies to be paid in installments, enhancing the investment element for the system as a whole, they explain.
“In other words – states Rosanna Sovani – a new State-industry pact is needed: advanced therapies must be managed with a payment contract in which, once the first installment has been honoured, the remainder will be paid by the National Health Service only and exclusively if it produces the expected benefits. That is, the state buys the long-term value of the therapy. And this approach fits well into the discussion on the new pharmaceutical governance currently underway at European level and with the HTA evaluation to which Advanced Therapies will be subjected first in 2025 pursuant to the European Regulation. However, we need to imagine a financial and accounting structure that allows this, a need that has already emerged – in more general terms – in the documents drawn up during the G20″.

What other countries do

We are also moving in this direction at a European level: the Eurostat Commission has activated working groups for the evaluation of intangible assets and social spending; the new 2021-2024 framework agreement signed between the French P&R Committee CEPS and the Leem trade association introduced the concept of “annuity payment model outcome based”, specifying that a change to the national regulatory framework will be necessary; Belgium is also studying a solution to correctly account for the outcome-based annuity payment model. Demonstrating that new developments cannot be treated with old regulatory and financial instruments.



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