From the monitoring of the sAifa pharmaceutical scale of 2020 it is clear that the ceiling of 500 million euro, set for Fund for innovative cancer drugs, has been smashed well 464.2 million. In fact, the total expenditure reached 964.2 million euros. 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 proves to be incapable, with worrying consequences for i patients who risk of no longer being able to quickly access innovative anti-cancer treatments. On the other hand, in 2020 there was a surplus of 193 million euros in the second Fund, that for innovative non-cancer drugs, which has an identical endowment, equal to 500 million.
Hence the need for a reform of the fund for innovative drugs that provides for an increase in the financial endowment for oncological therapies o 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.
These and many other proposals were the focus of the Webinar, organized by the Center for American Studies, entitled: “Funds for innovative drugs: an Italian best practice that can be improved”.
“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 guaranteeing access to innovation for patients and clinicians – he added – the funds for innovative drugs were born from an intuition that allowed access to a significant number of innovative molecules and that made sure that Italy kept up with innovation compared to other countries, allowing to recover what had been lost in the past. Several suggestions have been raised and I believe that the way to unify funds or greater availability are those that can also be followed in the parliamentary sphere ”.
To introduce the theme Claudio Jommi, Professor of Practice of SDA Bocconi School of Management and Scientific Director of the Medicines Observatory of Cergas: “From the GRHTA (Global & Regional Health Technology Assessment) publication on the Funds for innovative drugs, 4 recommendations emerged: first of all that of keeping the funds because they are a clear signal from the system towards high value drugs for the NHS and they meet objective and transparent criteria. Then there is the need to simplify the operation and to reschedule the amount of the Funds in a more flexible way, compared to the expected size of the innovation. Thirdly, and as a corollary to the first two points, 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 ”.
“The endowment of the two Funds, established with the 2017 Budget Law, must take into account the scientific progress made especially in the oncology field in recent years with the consequent new therapeutic possibilities for our patients “says Carmine Pinto, President of Ficog (Federation of Italian Cooperative Oncology Groups) according to whom the ceiling set at 500 million euros from the Fund for Innovative Cancer Drugs.
“The fund – he added – in recent years responded to two specific needs. First of all, to allow patients access to new therapies, in particular, in the period in which it was established, to immunotherapy that was facing clinical practice and which then changed the history of advanced neoplasms such as melanoma, cancer lung and kidney, doubling or tripling survival. In fact, the endowment of the FSN in those years was not able to cover the costs of these new therapies. Secondly, thanks to the ‘fast track approval’ guaranteed by the Fund for oncological drugs with recognition of innovation, 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 NHS of the single neoplastic pathology must be defined. 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 innovative drug , thus aligning its duration with clinical outcomes “.
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. “Today we understand what it means not to invest enough in healthcare – said Alessandra Sartore, Undersecretary for the Economy and Finance – with regard to the Funds for innovative non-oncological and innovative oncological drugs, I share the need to do something about flexibility in their management and on extending the duration of innovation. We can move forward on a new accounting for innovative therapies. It is essential to deepen through an open dialogue with Parliament to guarantee access to innovation for all patients ”.