in 2020 twice as much as expected was spent- Corriere.it

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The gloomy omens of the experts are confirmed by the numbers: the 500 million euro fund allocated for innovative cancer drugs in Italy is not enough. It happens for the first time and the “hole” is not a small one, given that the overrun in 2020 was 464.2 million: in our country the total expenditure for anti-cancer medicines included in the special category of innovative has in fact reached 964.2 million euros. After all, the price of cancer drugs has been growing steadily all over the world for years, along with the number of patients. The challenge has become increasingly clear: to make ends meet and ensure equal access to cancer treatment for all patients. Combining costs and ethics to continue to offer all people with cancer the best available therapies. And if the new treatments are available to us faster than the European average, the Italian oncologists had predicted that by 2020 the Fund set up in Italy in 2017 would most likely not be enough to be able to draw on them in an exceptional way in times of need. . By virtue of this hypothesis, the experts had also identified a possible solution: to redefine and simplify the management of the two existing funds, both of 500 million (one, in fact, for anti-cancer medicines and the other for all the others, in which in 2020 there was a surplus of 193 million euros), in the direction of greater flexibility so as to be able to mix them in case of leftovers or shortages.

Four concrete objectives to be achieved

The new estimates of the problem, deriving from the monitoring of the pharmaceutical expenditure of the Italian Medicines Agency (Aifa) for 2020, and the possible solutions were addressed during a meeting organized in recent days by the American Studies Center. To introduce the theme Claudio Jommi, Professor of Practice at SDA Bocconi School of Management and Scientific Director of the Cergas Medicines Observatory: “From the publication GRHTA (Global & Regional Health Technology Assessment) on the Funds for innovative drugs, 4 recommendations have emerged – explains Jommi -: first of all that of keep funds because they are a clear signal from the system towards high value drugs for the National Health Service and meet objective and transparent criteria. Then there is the need for simplify operation and to reschedule the amount of the Funds in a more flexible way, with respect to the expected size of the innovation. Thirdly, and as a corollary to the first two points, the extension of the innovation to more than 3 years should be evaluated, 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 experts’ need is therefore that of a reform of the Fund for Innovative Medicines 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.


That three-year limit that “must be tight”

They then ask for an extension of the stay in the Fund, beyond the current limit of 36 months, for drugs for which therapeutic alternatives are not available at the time of the loss of the innovative status. “At the time of its establishment, in 2017, the Fund was supposed to represent an emergency measure – he explains Carmine Pinto, president of FICOG (Federation of Italian Cooperative Oncology Groups) -. 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. 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 not replaced in clinical practice by another innovative drug, thus aligning its duration with outcome clinical “. Today, in fact, after three years, it is expected to be released because the requirement of innovativeness, which is temporary, automatically lapses. At the end of the 36 months, the financing of these therapies returns to the ordinary resources, which already see repeated deviations in pharmaceutical spending for direct purchases by the health authorities.

Italian patients first access the new treatments

«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 – continues Pinto -. For this reason, the ceiling set at 500 million euros for innovative oncological drugs must be increased, which in recent years has responded to two specific needs. First of all, allow patients access to new therapies, in particular, during the period in which it was established,immunoterapia which was approaching clinical practice and which then changed the history of advanced cancers 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. Secondly, thanks to the “fast track approval” guaranteed by the Fund, it was guaranteed to patients 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). «The priority is to continue to guarantee access to innovation for patients and clinicians – he comments Beatrice Lorenzin, head of Bridge Health & Science of the Center for American Studies and coordinator of the event -. 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, recovering precious time for the sick ».

Shorten the approval time

In 2020, in Italy, they were estimated 377,000 new cases of cancer and 3.6 million citizens live after diagnosis. “When they are truly effective and necessary, new drugs should not be seen as an item of expense, but represent an investment, because they allow for improved survival by contributing to the overall reduction of expenses for cancer care – he explains. Francesco Cognetti, president of FOCE (Federation of Oncologists, Cardiologists and Hematologists) -. In fact, Italy is the only European country in which in the period 2008-2018, in the face of an increase in the direct cost linked to anti-cancer drugs, overall spending on patient care decreased. 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. If it is appropriate to extend the period of stay in the Fund for Innovative Cancer Drugs beyond 36 months, the latency times between approval by the European regulatory body (Ema) and that of Aifa must also be resolved. It takes about a year, far too long for life-saving therapies ». The long process that 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. “I share the opportunity to expand the funding of funds for innovative drugs, given that the system has proven to work – he concludes Antonio Misiani, member of the Senate Budget Commission -. The main road should be that of unification ex ante. This intervention could be made in the 2022 Budget Law, but even better in DL Support bis, which will be examined by the Budget Committee 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. Then the evaluation of the innovativeness on objective criteria was good ».

May 25, 2021 (change May 25, 2021 | 16:28)

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