Supporting the Antibiotic Market to Ensure Future Preparedness

Monika Schneider, Shionogi

The emergence and spread of the novel coronavirus highlights the steep costs associated with a lack of preparedness for infectious diseases. Globally, nearly 2.5 million people have died, and trillions of dollars have been spent in a push to quickly develop countermeasures to this virus. As the distribution of vaccines begins a turning point in the fight against COVID-19, another, slower moving pandemic continues to simmer in hospitals and communities around the globe: antimicrobial resistance (AMR). Taking steps to ensure that we secure a robust arsenal of effective antibiotics now will save time - and lives - in the future.

AMR has been a growing threat due to a combination of factors. From a scientific perspective, as bacteria develop new mechanisms of resistance, it is harder to find drugs that will outsmart the bacteria. Bacteria develop mechanisms of resistance when antibiotics are overused or used inappropriately, like when antibiotics are prescribed to treat viral infections, or when antibiotics are used to promote the growth of livestock or in aquaculture environments.

Actions across different sectors of society can enhance antibiotic development and reduce AMR. These approaches include changes to clinical development, manufacturing, access, and stewardship. For clinical development, harmonizing global regulations and establishing clinical trial networks can reduce the time to market for an antibiotic. Once on the market, opportunities for resistance development can be reduced through appropriate use and environmentally responsible manufacturing. And ensuring global access to effective antibiotics when appropriate can not only save lives, but also decrease transmission of AMR. Underpinning these measures is support for preserving current antibiotics and encouraging the development of new products.

New antibiotics are also needed to effectively combat the AMR threat – now and in the future. But the scientific challenges to creating these new drugs, coupled with financial hurdles once they are on the market, result in a shrinking set of potential new treatments. Globally, the antibiotic pipeline contains 47 candidate products, and only fourteen of those candidates are expected to target critical priority pathogens. In contrast, more than 450 products are being developed for metabolic disorders. Without improved investment in the antibiotic space, we will be unprepared for another infectious disease crisis.

Unfortunately, development in this area has slowed because the economic incentives that typically drive innovation have fallen away. Investment in research and development depends in part on the potential market for a new drug. Antibiotics targeting resistance mechanisms that won’t be widespread until the future do not get used or sold frequently in the present, because they are reserved to protect effectiveness.

These utilization patterns point to the core challenge that antibiotics face: existing purchasing and reimbursement mechanisms are not meant to reward future preparedness. As a result, limited revenue is the primary economic challenge to antibiotic success.

Many stakeholders have articulated these issues and potential approaches to address them. Recently, the pharmaceutical and biotechnology industry has demonstrated their commitment to the future of antibiotics through creation of the AMR Action Fund: nearly $1 billion contributed by companies to support development and approval of 2-4 new antibiotics over the next 10 years. This fund can lower the cost of antibiotic development, but it will not address revenue shortfalls after approval. Without additional measures to fix the antibiotic market, the impact of the AMR Action Fund will be limited. However, this issue is too large for the private sector to solve alone – it will require cooperation between industry and governments, as well as international coordination. Nations need to step up and commit to real changes in how antibiotics are valued once they make it to market.

In particular, US legislative action is needed to implement a significant and sustainable incentive. Two potentially impactful bills have been introduced in the US Congress: the DISARM and PASTEUR acts. DISARM would provide an add-on payment to hospitals when they use a qualifying antibiotic, reducing the financial disincentive to use of new drugs. The PASTEUR act represents a different way to pay for antibiotics altogether, establishing subscription contracts that would delink antibiotic payment from the frequency of antibiotic use. Delinked payments mean that the antibiotic revenues would no longer be tied to the number of units sold. Enactment of these legislative proposals would be a significant step toward creating a sustainable and predictable market for antibiotics, as well as in preparing the US against future AMR threats.

Major action on the part of the US government would align with and support the efforts on antibiotic payment that are being implemented in other countries. In the United Kingdom and Sweden, new models are being tested that redefine how antibiotics are valued by rewarding antibiotics based on their ability treat resistant infections and to be effective against future infections. In Sweden, the government is guaranteeing a minimum yearly payment for antibiotic availability, regardless of use. In the UK, an enhanced value assessment will set the payment amount for a multi-year purchasing contract. These innovations, if successful, will help to create a more predictable antibiotics market.

AMR is a multi-faceted and global problem, and it will take multi-sector collaboration to ensure that we are prepared to address resistance as it emerges. Action is urgently necessary to fix the incentive structure and enable greater antibiotic innovation. Only through reinvestment today in infectious disease threats like AMR will we is be prepared to save lives and prevent health and economic crises in the future.