2023-12-15 09:46:31
by Chiara Daina
These innovative medicines can lead to the patient’s complete recovery or very high functional recovery. But there is a problem of economic sustainability for health systems. A possible solution from an accounting point of view
Advanced therapies (gene, cell and tissue engineering therapies) represent a hope for a cure for many seriously ill patients without effective alternatives. A medical revolution that is already a reality and which today generates a challenge in terms of economic sustainability for healthcare systems due to high production costs. Advanced therapies consist of innovative biological medicines that contain genes, stem cells or tissues modified in highly specialized laboratories with the aim of repairing non-functioning ones in the body.
They are the new frontier for the treatment of some rare pathologies, such as SMA, i.e. spinal muscular atrophy, thalassemia, retinitis pigmentosa, congenital immunodeficiency and diseases that cause eye lesions explains Paolo Gasparini, professor of medical genetics at the University of Trieste and coordinator of clinicians at the Committee for Advanced Therapies of the European Medicines Agency.
They are generally “one shot” therapies, i.e. administered with a single treatment, whose benefits manifest themselves progressively in the following months and years and promise to be long-lasting. The cost ranges from around 800 thousand euros up to three million per dose. Potential beneficiaries must have certain clinical characteristics to access the treatment. In Italy it is estimated that there may be a few hundred eligible patients and globally by 2030 at least 500 thousand.
Car-T: how much do they cost
Advanced therapies include the famous Car-T, personalized therapies against certain types of cancer (lymphomas and aggressive leukemias) that use the patient’s own immune cells (T lymphocytes), which are extracted and genetically corrected to then be reinfused into the body. In this case the cost is around 200-300 thousand euros and the beneficiaries are thousands, both adults and children, specifies Gasparini. Promising success.
Advanced therapies can lead to complete recovery of the patient or to a very high functional recovery, underlines the geneticist. The ability of states to cope with high spending on advanced therapies is a decisive and priority issue today, to avoid the possibility of having to ration treatments tomorrow, treating a lower number of patients than those who would be entitled to it.
How to reconcile patient needs and state accounts
A possible solution to reconcile the need to treat all eligible patients with that of containing public accounts comes from the High School of Economics and Management of Health Systems (Altems) of the Catholic University of Rome, which in collaboration with the association professional Ls cube law firm conducted the first economic and accounting analysis on advanced therapies, which concludes with the proposal to establish an ad hoc experimental fund with different accounting, which allows a payment model spread over time and paid to the manufacturer only if the expected benefits occur.
To understand the meaning of the proposal, a premise must be made: Public spending is divided into current spending, relating to the need for goods and services in the current year, and capital spending, used to finance investments. The purchase of traditional medicines is part of current spending commitments – clarifies Mauro Mar, professor of financial sciences at the University of Tuscia in Viterbo and at the Luiss University of Rome, who was part of the group of experts who contributed to the preparation of the study —. Advanced therapies, on the other hand, despite being administered only once at a specific time and accruing effective costs concentrated in the first year, generate clinical, social and economic effects that go beyond the annual duration. They improve the person’s quality of life, allow them to return to school or work, not to resort to other drugs and other forms of assistance, generating savings for the National Health Service.
For this reason they should be evaluated as an investment, like a car, a bridge, a piece of equipment, a computer, in short like any tangible durable good. To prevent it from becoming a problem for the state budget, spending on advanced therapies must follow the cash criterion, which allows expenses to be accounted for when they are actually paid regardless of the moment in which the obligation to pay arises, and not the accrual criterion, for which there is an obligation to spend in the current financial year. In this way it will be possible to divide the resources without negative effects on the budget balance.
Americo Cicchetti, general director of health planning at the Ministry of Health, highlights precisely that there are rigidities in state accounting that should be overcome by reviewing the classification of spending on advanced therapies. Being characterized by a temporal misalignment between actual costs, concentrated in the short term, and future benefits spread over the years. In practice, the formula advanced by Altems, to ensure financial coverage by saving public accounts, translates into a payment contract between the State and industry in which, once the first installment has been honoured, the remainder will be paid by the Health Service national only and exclusively if the therapy produces the expected benefits – explains Rosanna Sovani, partner of Ls cube law firm -. The state, that is, 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 in the new European regulation on Health technology assessment, the methodology for evaluating health technologies, to which advanced therapies will be subjected first in the 2025. 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.
25 advanced therapies approved by EMA and data in Italy
At the moment – we read in VI Italian Report on advanced therapies of the Atmp Forum – There are 25 advanced therapies authorized by the European Medicines Agency (EMA), of which 7 have been withdrawn from the market by the manufacturing company.
In Italy, there are 8 those on the market and already reimbursed by the Italian Medicines Agency (Aifa), another 3 are in class C, i.e. paid for, and 6 are being evaluated for the definition of price and reimbursement. In 2022 the expenditure was 85.8 million euros, of which 70.3 for Car-Ts alone (which in fact show a consumption 5 times higher than other therapies).
The impact on total public pharmaceutical spending (23.5 billion) is 3.6 per thousand. Over 80% of the expenditure was supported using the National Fund for the purchase of innovative medicines (around one billion euros).
There are 111 healthcare facilities authorized to administer advanced therapies, distributed across all regions, but 60% are active (65). As regards the average access times, at a national level we are talking about around 300 days, with a gap between the regions of the Centre-North (281) and those of the South (333).
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December 15, 2023 (changed December 15, 2023 | 08:46)
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