2023-11-15 16:54:00
It is “fundamental and urgent to also adopt measures in Italy that encourage innovation and promote research to effectively address the problem of antibiotic resistance and support the development of new antibiotics”. This is supported by the experts present at the event ‘Value and sustainability of antibiotics as indispensable tools for the healthcare system and people’s health’, organized today by The European House – Ambrosetti with the non-conditioning contribution of Shionogi. During the meeting, experts and institutions discussed the state of the art of the availability of antibiotics, in particular the so-called Reserve ones – antibiotics of last resort and used only in the most serious cases, when all other alternatives have not been successful, such as, for example, for multi-resistant infections – and on which measures and tools, both in terms of financing and price evaluation and reimbursement, can incentivize investments in research and development of new antibiotics and combat antimicrobial resistance (Amr).
In the last year – explains a note – the fight against antimicrobial resistance has entered the political agenda, with the publication, in February 2023, of the second National Plan to fight antimicrobial resistance (Pncar) 2022-2025 financed with 40 million of euros for the years 2023-2025. Despite this and the “presentation of a bill for the prevention and control of healthcare-related infections, often caused by multi-resistant pathogens – states Massimo Andreoni, professor of infectious diseases at the University of Rome Tor Vergata and scientific director of the Italian Society of Infectious and Tropical Diseases (Simit) – in Italy, no incisive political-institutional actions have been taken to make antibiotics aimed at the treatment of infections available and sustainable, from an economic point of view resistant with limited treatment options, and classified as Reserve by the WHO”.
Every year AMR causes 4.3 million infections and 79 thousand deaths in OECD countries. In a worst-case scenario, by 2050, the annual healthcare cost of treating complications caused by resistant infections could reach $28.9 billion and more than $36.9 billion in lost productivity. The research and development process of a new antibiotic is today extremely complex and risky: only 1.5% of the molecules in the pipeline enter clinical practice, 1 in 30 for new classes of antibiotics. Since 2017, only 12 new antibiotics have been approved, 10 are from existing classes, which already report antimicrobial resistance mechanisms, while only one is effective against both pathogens – CR Acinetobacter baumannii and CR Pseudomonas aeruginosa pathogens – which are more difficult to treat. Antibiotics are therefore a very high risk investment and pose a sustainability problem for the company. Faced with the enormous unmet clinical need, it is urgent to make the R&D of antibiotics more attractive and competitive, especially for the Reserve type.
A legislative and regulatory framework more favorable to innovation in the antibiotics sector – according to experts – should adapt existing policy instruments (such as the Innovation status) to the peculiarities of the sector by activating Push-type incentives and benefits – encouraging the R&D of new products – and Pull – ensuring availability and access. The various Push incentive programs (public-private partnerships, financing, tax breaks, etc.), such as those activated by policy makers, industry and the philanthropic community in the United States and the European Union, must be increased to maximize their effectiveness and accompanied by Pull incentives, introduced by some European countries (France, Germany, United Kingdom and Sweden) but not in Italy. These incentives (market exclusivity, advance purchase agreements, clawback exemption) help ensure a fair return on investment for the most innovative antibiotics and, at the same time, promote accessibility and stewardship efforts.
“The most significant problem – underlines Daniela Bianco, partner and head of the Healthcare area of The European House Ambrosetti – is the absence of a connection between the price and reimbursement system and that of research and development of new antibiotics. Push and Pull mechanisms or other incentive systems cannot be limited exclusively to the final phase of the product’s entry into the market, but must be part of a broader system that takes into account the risk of the initial investment and the value of have a new antibiotic. This is a very hot topic at an international level, debated in the last G7 under the Japanese presidency, and given attention in the context of the new proposal for the European Pharmaceutical Strategy”.
In the case of antibiotics, especially those of the Reserve type, the return on investment from sales is not sufficient to cover R&D costs. The short duration of treatments, as well as antimicrobial stewardship policies, which correctly recommend limited and appropriate use, reserving the most innovative ones for subsequent lines to slow down the development of resistance, impact the antibiotic sector, already characterized by market prices relatively lower than other drugs, experts say. “In light of the experiences already underway at a European and international level – underlines Simona Falciai, General Manager of Shionogi Italia – the hope is that even in Italy, which unfortunately still holds the negative record for infections by multi-resistant pathogens, it will be possible to introduce new governance and financing models to support the R&D of new antibiotics and in order to guarantee access and economic sustainability in the medium/long term for existing Reserve antibiotics”.
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