OCTOBER 2023LIFE SCIENCES REVIEW8IN MY OPINIONTHE VALUE OF NEW ANTIBIOTICS IN THE FIGHT AGAINST AMRPiero Rijli, Corporate Director, Regulatory Activities and Market Access, MENARINI Grouphe rising resistance to antimicrobials observed among an increasing number of microorganisms represents a direct threat to human health. The AMR is far from even slowing down, on the contrary it is steadily increasing. This has profound consequences for the treatment of infections because it limits the treatment options. This limitation in our ability to treat infections effectively has an impact on the sustainability of the health systems and more broadly on other economic sectors.Patients infected with a resistant microorganism are less likely to recover with the first antimicrobial therapy and will require extra efforts and treatment. This may impair the long-term effectiveness of antibiotics, delay access to effective treatments, increase the rates of treatment failure with concomitant complications, increase the hospital stays and eventually lead to higher fatality rates. Resistance also affects empirical treatment ­ where the clinician selects an antibiotic for the treatment of an infection in the absence of microbiological results ­ which might result in an underestimation of the risk associated with specific infections and the use of inappropriate antibiotics. The use of accurate and easy to use rapid diagnostic testing at point of care should be increased to rapidly detect the pathogens responsible for the infection. The impact of AMR is more dramatic in hospitalized patients and particularly for vulnerable patients such as immunocompromised and the critically ill. These patients are also exposed to a higher risk of infection by resistant bacteria through contact with health care delivery services, the invasive procedures their conditions often require, and frequent antibiotic treatments.The economic burden of AMR comes from the fact that its cost it is not immediately visible because consumer and supplier see only a small part of it. Furthermore, AMR compromises the success of many medical interventions that depend on the effective treatment and prevention of infection; for example: immunosuppressive therapies, chemotherapies, and surgeries. Thus, AMR can undermine the safety of hospitals and that of many interventions that require antimicrobial prophylaxis. On top of that, AMR has potential detrimental impacts on several social and economic sectors (e.g., the labour market, livestock industries, the tourism industry, etc). The effects of AMR on societal outcomes are determined mainly by the higher morbidity and mortality it leads to. These two factors affect the size of the labour force and labour productivity.This has led to the current situation, where information on the economic burden of resistance is available, but the value of that information to those in charge of designing and implementing strategies to deal with resistance is limited.There is a need to raise awareness and educate health economists, pharmaceutical companies, policy, and decision makers that antibiotics are associated with multiple value elements and that economic evaluations need to be conducted at population level to account for externalities related to antibiotic use. This determines that as for other areas of unmet medical need, pricing and reimbursement of new antibiotics should reflect the real societal value and not just the price/volume dimension.The regulatory authorities and reimbursement bodies need to work together. It is difficult to consider the health gain of an antibiotic in an economic evaluation looking only at non-inferiority trials. PK/PD data should also inform the decision together with microbiology TPiero Rijli
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