The 500 million euros allocated by the Fund for innovative oncological drugs were not enough. For the first time, the ceiling was breached by as much as 464.2 million, reaching a total expenditure of 964.2 million euros. An overrun that is worrying because patients risk being unable to access innovative anti-cancer treatments in a short time. It was different, however, for the Fund for innovative non-oncological drugs, which have an identical budget, equal to 500 million and which recorded a surplus of 193 million euros. Innovative funds, access times and increase in resources were discussed in the Webinar, organized by the Center for American Studies, entitled: “Funds for innovative drugs: an Italian best practice that can be improved”.
Operational proposals
In the three-year period 2017-2019, there had never been any breakthroughs. For the first time since its inception in 2017, therefore, the Fund proved insufficient. From this overrun and from the surplus of the other Fund, the need arises for a reform of the fund for innovative drugs which provides for either an increase in the financial endowment for oncological therapies or compensation mechanisms in the event of a breach of one of the two sources. Not only. An extension of the stay in the Fund, beyond the current limit of 36 months, should also be envisaged for drugs for which therapeutic alternatives are not available at the time of the loss of the innovative status. “Today we understand better what it means not to invest enough in Healthcare – he says Alessandra Sartore, Undersecretary for the Economy and Finance. As regards the Funds for innovative non-oncological and innovative oncological drugs, I agree with the need to do something about the flexibility in their management and the extension of the duration of innovation. It is essential to deepen through an open dialogue with Parliament to guarantee access to innovation for all patients ”.
How to reform funds for innovative medicines
by Tina Simoniello
The four recommendations
From the GRHTA (Global & Regional Health Technology Assessment) publication on the Funds for innovative drugs, 4 recommendations emerged: “First of all, to keep the funds because they are a clear signal from the system towards high value drugs for the National Health Service and they meet objective and transparent criteria ”, he explains Claudio Jommi, Professor of Practice at SDA Bocconi School of Management and Scientific Director of the Cergas Medicines Observatory. “Then there is the need to simplify the operation and to reschedule the amount of the Funds in a more flexible way, with respect to the expected size of the innovation. Thirdly, the extension of innovativeness to more than 3 years must be assessed, maintaining consistency between extension and the need to invest in new entries of innovative drugs on the basis of available resources. Finally, further evidence must be produced on two fronts: access at the regional level and the impact on health expenditure ”.
Cancer costs 20 billion every year
Scientific innovations
The experts reiterated the need to take into account the scientific progress made especially in the oncology field in recent years with the consequent new therapeutic possibilities for patients. “This is why the ceiling set at 500 million euros for the Fund for innovative oncological drugs must be increased, which in recent years has responded to two specific needs”, he notes Carmine Pinto, President of FICOG (Federation of Italian Cooperative Oncology Groups. “First of all, to allow patients access to new therapies, in particular, in the period in which it was instituted, to immunotherapy that faced clinical practice and which then changed the history of advanced stage neoplasms such as melanoma, lung and kidney cancer, doubling or tripling survival. The endowment of the National Health Fund, in fact, in those years was not able to cover the costs of these new therapies “.
Access to drugs: 90% of oncologists request “preview” therapies
by Tiziana Moriconi
Not spending but investment
In 2020, in Italy, 377,000 new cases of cancer were estimated and 3.6 million citizens live after diagnosis. “When they are truly effective and necessary, new drugs should not be seen as an expense, but represent an investment, because they allow for improved survival by contributing to the overall reduction of expenses for cancer care”, he declares Francesco Cognetti, President of FOCE (Federation of Oncologists, Cardiologists and Hematologists). “The Fund has made it possible to quickly access truly revolutionary therapies, which have favored savings for the health system in other items. It has therefore helped to ensure sustainability. And we can’t go back. It is therefore appropriate to extend the period of stay in the Fund for innovative oncological drugs beyond 36 months.
Shorten approval times
But the latency times between approval by the European regulatory body (EMA) and that of AIFA must be resolved. It takes about a year, far too long for life-saving therapies. “This long process – continues Cognetti -, which goes from European approval to the actual availability of the drug for patients in our country, can severely penalize the sick, especially in the case of diagnosis at advanced stages of the disease. It is therefore essential to ensure timely availability. The Fund has made it possible to eliminate the need for the inclusion of innovative drugs in regional therapeutic handbooks, moreover, compassionate use programs are sometimes activated and there are rules that regulate the so-called ‘early access’, i.e. the access and prescription of already approved therapies. by the European regulatory body, before reimbursement by the National Health Service. In any case, there remains the problem of the time required for the approval of AIFA, which should be limited to verifying the economic compatibility of a therapy, without reviewing the aspects relating to clinical efficacy, already assessed by EMA. And the criteria with which AIFA defines innovation must be reviewed ”.
Il ‘fast track approval’
The other aspect to consider is that of the ‘fast track approval’ guaranteed by the Fund for oncological drugs with recognition of innovation thanks to which patients were guaranteed immediate access to these drugs after central approval by AIFA. This result was achieved if we consider that cancer patients in our country, in the period 2016-2019, had access to a greater number of new anti-cancer drugs (33) than the European average (24). “At the time of its establishment in 2017, the Fund was supposed to represent an emergency measure – continues Pinto. Today we need a rescheduling of all pharmaceutical spending. Not only the cost of the drug must be considered, but the entire cost of assistance for the National Health System of the single neoplastic pathology must be defined “.
Raise the roof
Pending a structural reform, the ceiling of 500 million euros for oncological drugs must be increased. “Once the capacity of the Fund has been ensured, the definition of innovativeness and therefore the criterion of permanence of a drug in the Fund must be guaranteed beyond the current 36 months, until that single drug is replaced in clinical practice by another new drug innovative, thus aligning its duration with clinical outcomes ”, continues Pinto. Today, however, after three years, it is expected to be released because the requirement of innovation, which is temporary, automatically lapses. At the expiry of the 36 months, the financing of these therapies returns to ordinary resources, which already see repeated differences in pharmaceutical expenditure for direct purchases by health companies.
How to reform the system of funds
It also shares the need to intervene on the Funds Antonio Misiani, member of the Senate Budget Commission: “I share the opportunity to expand the funding of funds for innovative drugs, given that the system has proven to work. The main road should be that of ex-ante unification. This intervention could be implemented in the Budget Law 2022, but even better in the DL Sostegni bis, which will be examined by the Budget Commission of the Chamber. Also worthy of consideration is the extension of the duration of innovation beyond 36 months, which is appropriate if there are no substitute drugs. The evaluation of innovativeness on objective criteria also performed well “.
The problem of sustainability
Since the state stock exchange has its limits, the problem of the sustainability of advanced therapies arises. “A possible solution to meet the costs of anti-cancer therapies, without additional costs for the National Health Service – proposes Antonio Gaudioso, President Cittadinanzattiva – is the creation of a Single Fund, which responds to the need to avoid the overrun in the Fund for innovative oncological drugs in the face of the surplus in that for non-oncological drugs determined, in large part, by the exit of anti-cancer therapies – hepatitis C. However, it is important to emphasize that the contribution to the sustainability of the system offered by the Fund should not exempt clinicians from the obligation of appropriateness and from the commitment to improve adherence to care. Greater adherence means lower risk of hospitalization, fewer complications associated with the disease, greater safety and efficacy of treatments and reduction of costs for therapies “.
“On the issue of funds for innovative drugs, the response of the institutions is unanimous: they have been an effective tool and deserve to be strengthened.” To declare it is Beatrice Lorenzin, head of the Bridge Health & Science of the American Studies Center, coordinator of the event. “The priority is to continue to ensure access to innovation for patients and clinicians. The funds for innovative drugs were born from an intuition that allowed access to a considerable number of innovative molecules and that made Italy keep pace with innovation compared to other countries, allowing to recover what it had been lost in the past ”.
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