Since their discovery, antimicrobial medicines have revolutionized the fight against disease and today represent one of the greatest achievements in public health. But after decades of helping to lower the mortality rate from pneumonia, tuberculosis and other types of infection, the medicines we rely on now face the growing threat of antimicrobial resistance (AMR).
AMR is a natural process that occurs when microorganisms such as bacteria, viruses, fungi and parasites change in ways that make the medications used to cure the infections they cause ineffective. A growing list of infections – including pneumonia, tuberculosis, blood poisoning, gonorrhea and foodborne diseases – are becoming harder, and sometimes impossible to treat as our current arsenal of medicines are not effective against resistant strains of the microorganisms that cause these infections.
AMR can affect anyone, of any age, in any country. According to the Centers for Disease Control and Prevention (CDC), more than 3 million antibiotic-resistant infections occur in the U.S. each year, and 48,000 people die as a result. And according to a recent GAO report, because of inadequate surveillance, this may actually be an underestimate of the extent of the problem. A lack of sufficient point of care diagnostics also makes it difficult for physicians to get the right treatment to the right patient at the right time. As a result, AMR threatens many modern medical advances that depend on antimicrobial medicines to fight potential infections, including joint replacements, organ transplants and cancer therapy.
R&D to address AMR is dwindling and the current environment for investment is insufficient to achieve a sustainable pipeline.
To control the growing resistance to antimicrobial medicines, stewardship programs and treatment guidelines limit the use of new antimicrobials in an effort to slow down the process. However, experts continue to worry that the increased use of these medicines may lead to faster growth and even greater rates of resistance.
Although biopharmaceutical researchers are investigating new antimicrobial medicines to counteract the microbes’ evolving defenses, the current pipeline of new treatments for resistant infections is inadequate due to several challenges that have slowed R&D in this area.
First, newer antimicrobial medicines are often more expensive than older versions and due to bundled payment systems, many hospitals are driven to using generic medicines, which while less expensive, may not be the best course of treatment. Additionally, stewardship programs are appropriately designed to limit the use of new antimicrobial treatments to only the most necessary cases, limiting the potential revenue from volume of sales. As a result, when companies develop new treatments – often a costly and time-consuming process – it can be challenging to earn back investment. Facing an unsustainable market, many companies have closed or scaled back their research into new antimicrobial treatments, and some smaller companies have gone out of business altogether.
Several policy solutions exist that could help tackle these challenges.
Comprehensive policy solutions are needed to help ensure a sustainable pipeline for new treatments for resistant infections by:
- removing antibiotics meeting certain criteria from bundled payments in Medicare, which can remove disincentives for the use of the most appropriate antimicrobial treatment for patients;
- providing a sufficient early return on investment after U.S. Food and Drug Administration approval to ensure continued availability of treatment options; and
- decoupling reimbursement for antibiotics from volume, through novel payment mechanisms like subscription models that provide consistency regardless of how often treatments are used.
While we continue to fight COVID-19, AMR is an emerging threat that’s right before our eyes. The World Bank Group’s 2017 report on drug-resistant infections estimates that unless action is taken, AMR could take 10 million lives annually by 2050, a higher toll than from cancer. As discussions take shape around future pandemic preparedness, it will take a multi-stakeholder effort, including supportive policies, changes in prescribing habits and sustained investment in new treatments to tackle the growing threat of AMR.
Jocelyn Ulrich Jocelyn Ulrich, MPH, is Deputy Vice President, Policy and Research, at the Pharmaceutical Research and Manufacturers of America (PhRMA). At PhRMA, she is responsible for developing legislative and policy analysis and research studies on a range of issues impacting innovative biopharmaceutical companies including intellectual property issues, FDA policy issues, the R&D process, the value of innovation, and other issue areas impacting the environment for innovation. In addition to her experience at PhRMA she has over 15 years of experience in the pharmaceutical industry at Pfizer, Human Genome Sciences, and EMD Serono in roles in clinical research management, investigator-initiated and collaborative research, and global policy and corporate affairs. Jocelyn holds an MPH in global health policy and management from New York University.