Panel
Reducing the Cost of Antimicrobial Resistance
Milken InstituteAllan Coukell, Ella Balasa, Nick Crabb, Mark Feinberg, Jeremy Knox, Jenelle Krishnamoorthy, Alan Kockel, John Rigg, Robert Horn
Context and Urgency
- The World Health Organization identified antimicrobial resistance (AMR) as a top public health priority for 2019.
- Prior to the 1937 introduction of antibiotics, the standard of care for infectious diseases like sepsis was limited to bed rest and nursing.
- For decades, society took antibiotics for granted, but current trends show resistant infections are increasing while the number of companies developing new antibiotics is shrinking.
- Experts employ a "fossil fuels" analogy: the strategy requires both reducing consumption of existing antibiotics and generating new treatments.
The Economic "Valley of Death"
- Antibiotics present a poor return on investment compared to chronic disease drugs (e.g., Hepatitis C at $11B or cancer drugs at $30k+) due to low volumes and strict stewardship requirements.
- Major pharmaceutical companies like Merck remain in the antibiotic space due to historical commitment and diversified portfolios, but most lack the resilience to absorb high R&D risks without offsetting revenue.
- A recent approved antibiotic company went out of business in 2019, signaling the fragility of the current market model.
- Small biotech firms successfully develop early-stage assets but face a "valley of death" where they cannot raise funds to advance to Phase 2 and 3 trials or find buyers in big pharma.
- Current push incentives (e.g., CARB-X, BARDA, GAIN Act) have successfully stimulated early research but have not solved the late-stage commercialization barrier.
Proposed Solutions and Market Mechanisms
- Pull Incentives (Subscription Models): The UK is piloting a novel subscription model where the NHS pays a fixed, multi-year sum for the value of an antimicrobial rather than volume sold, aiming to decouple revenue from usage.
- Valuation Challenges: Health technology assessments (HTA) must evolve to capture "diversity value," including benefits like slowing resistance rates in existing drugs and enabling better stewardship cycles.
- Risk Sharing: Proposals include pooling risk between public, private, and philanthropic actors to make late-stage R&D an investable proposition without relying solely on public funds.
- Global Coordination: While the US and UK lead in funding and policy, there is a critical need to expand this engagement to G20 nations to ensure a global solution, as AMR knows no borders.
- Pharmaceutical Industry Role: Big pharma remains the only entity with the capability to handle late-stage clinical development and global commercialization; removing private sector involvement risks killing the innovative ecosystem.
Stewardship and Diagnostics
- Successful antibiotic development is inextricably linked to robust stewardship; without usage limits, new drugs will quickly lose efficacy.
- A U.S. regulation recently mandated antibiotic stewardship programs in hospitals for Medicare payment eligibility.
- Rapid diagnostic testing is identified as a critical bottleneck; current delays in identifying pathogens force the use of broad-spectrum antibiotics, accelerating resistance.
- In low- and middle-income countries, a lack of supply chain sophistication and counterfeit drugs creates a major stewardship gap requiring new models of industry-government collaboration.
Emerging Therapeutics and Public Perception
- Traditional small-molecule antibiotics are being supplemented by alternative approaches like phage therapy (using viruses to target bacteria), which a cystic fibrosis patient utilized after failing traditional treatments.
- The Cystic Fibrosis Foundation has launched a $100 million Infection Research Initiative to fund novel therapies like nitric oxide inhalers.
- Current regulatory frameworks (e.g., GAIN Act) often exclude non-small molecule therapies, creating a need to broaden definitions of what qualifies for AMR incentives.
- Communication Gap: A major barrier to political action is the lack of public outrage; current messaging about AMR is too abstract (e.g., "10 million deaths by 2050") and fails to convey immediate, personal risk.
- Effective communication requires framing AMR as an immediate, tangible threat to individuals and families rather than a distant global statistic.
Panel Consensus and Future Outlook
- There is no single "silver bullet"; solving AMR requires a continuum of push funding, pull incentives, stewardship, and diagnostic innovation.
- The window to act is closing; once scientific expertise and industry capacity leave the sector, it may become impossible to regenerate it.
- Collaboration between sectors (public, private, philanthropy) is essential, as each has distinct capabilities, limitations, and incentives that must be aligned.
- Stakeholders urge policymakers to move beyond discussions to concrete action on reimbursement models that make antibiotic development financially viable.