Policy & Regulation News

Combating Antimicrobial Resistance Through Global Market Reform

A Pioneer Institute report found that “push” and “pull” funding can reform the current market to reduce the antimicrobial resistance crisis globally.

Antimicrobial Resistance

Source: Thinkstock

By Samantha McGrail

- A Pioneer Institute report found that market reforms using “push” and “pull” funding will help to combat the global antimicrobial resistance crisis. 

The CDC considers antibiotic resistance to be “one of the biggest public health challenges of our time,” with nearly 700,000 people dying each year from drug-resistant infections.

Additionally, nearly 47 million antibiotic prescriptions are used unnecessarily each year. Of the 40 million individuals who are prescribed a course of antibiotics for respiratory illnesses annually in the US, just 13 million need them. 

Overall, antimicrobial resistance could kill nearly 10 million individuals annually, with the potential of a cumulative $100 trillion in lost economic output by 2050, according to data cited in the report. 

The current market and reimbursement methods, combined with the way antibiotics are used to treat illness, make them a risky investment for pharmaceutical companies.

Specifically, nearly 75 percent of companies developing antibiotics are considered pre-revenue, meaning that they have no products on the market and are vulnerable to becoming destabilized.

This leads to less pharmaceutical research & development and many experts fear that the COVID-19 pandemic is heightening this crisis.

Many hospitals and care facilities are turning to antibiotics to provide protection or treatment for secondary infections patients may acquire as a result of the virus. Specifically, about 90 percent of COVID-19 patients are being treated with antibiotic prescriptions due to secondary infections, including respiratory illnesses. 

“One need not look further than the coronavirus pandemic to see the immense cost of infectious disease on such a macro scale,” researchers said. “Mere months into the global pandemic, the United States has already spent trillions on economic relief and efforts to tackle the virus.”

To reduce the antimicrobial resistance issue, both governments and the biopharmaceutical industry recognizes the need for market reform, as this is key to creating a sustainable antibiotic ecosystem. 

And according to researchers, the two most broadly endorsed fixes to the market come from “push” and “pull” funding. 

Push incentives are financial rewards that aim to de-risk the drug development process before a drug is approved, while pull funding, which is more difficult to implement, is payment for outcomes based on success.

The AMR Action Fund, created by leading pharmaceutical companies, is an example of a push funding mechanism.

The fund aims to “invest more than $1 billion in smaller biotech companies and provide industry expertise to support the clinical development of novel antibiotics.” The goal is to deliver two-to-four new antibiotics by 2030.

Additionally, Congress introduced a proposal in 2019 called the DISARM Act, which would create higher Medicare reimbursement for new antibiotics, while also requiring the hospitals that receive increased payments to use the drugs appropriately. 

DISARM would cut novel antibiotics out of the Medicare payment scheme and force Medicare to value antibiotics as breakthrough drugs instead of commodities, researchers explained. 

The act would “ensure that every antibiotic will be reimbursed regardless of its price to allow doctors to make decisions scientifically and not financially.” 

But some critics said that DISARM could encourage too many doctors to rush to prescribe new classes of antibiotics and lead to growing antibiotic resistance trends for novel drugs, while others said that elevating financial reward could increase spending on drugs.

Due to the rate of antibiotic misuse, physicians must be able to understand what they are treating and uncover new ways to understand the bacterial infections affecting patients, researchers explained.

Finally, an awareness campaign must be implemented on the state and national levels, researcher recommended. This would help to address an impending threat posed by infectious diseases to the current health climate. 

“Action is needed now. It can take over a decade from the time when an antibiotic candidate is identified to clinical use and regulatory approval,” researchers said.

“The years immediately following that approval are most critical for the drug’s sustained place in the drug ecosystem, it is when drug makers seek the revenue to recoup losses incurred during the development phase. Regulatory, educational and stewardship actions now will pay dividends later.”