To Get More New Antimicrobial Drugs, Fix the Broken Market, Experts Say

Fixing the broken market for innovative antimicrobial drugs should start with the hospitals, said Christine Ann Miller, MBA, at the Future of Health Summit sponsored by the Milken Institute on Tuesday.

Because hospitals under the diagnosis-related group (DRG) system get paid a lump sum for treating a patient with a particular disease or condition, “hospitals are disincentivized from using newer innovations — they see a new antibiotic or new antifungal coming into the market as their costs going up,” she said. “The hospital’s going to lose money. They don’t see the innovation as something that’s welcomed. And so rather than taking a few weeks or a few months for a new product to get on a formulary at a hospital, it can take years, and that means that patients don’t get access to the medicines that they need.”

“What we need to do is we need to fix the reimbursement model,” Miller added. “There are some mechanisms like NTAP [New Technology Add-on Payment], which is a new add-on technology payment that CMS has set up that helps to provide some reimbursement above what it’s providing in the DRG, but that mechanism needs to be reformed to support the uptake of antimicrobials, which takes years to happen.”

“If we really want to speed innovation, we need to fix the marketplace, and that will incentivize investors to spend money in this space,” she said, noting that in 2020, investors put $7 billion into developing new oncology drugs, “but in the same period, you know what antimicrobials had in terms of investment? $160 million.”

Gunnar Esiason, MPH, MBA, head of patient engagement at RA Ventures, a venture capital firm, agreed. “I work at a $10 billion investment fund, and investors, like companies, are rational actors,” said Esiason, who is also a cystic fibrosis patient. “You are chasing revenue to return the financing that is put into the company’s pool. And right now in antimicrobial development, there is no clear path to sustainable and profitable revenue … and when companies do not have a clear path to revenue, the market dries up. And that’s what’s worth fixing.”

Meanwhile, patients and providers are unconsciously fueling the rise of antimicrobial resistance, said Lynn Goldman, MD, dean of the Milken Institute School of Public Health at George Washington University in Washington, D.C.

“People decide where to go with bladder infection or some other infection nowadays by searching for acute care and looking at the customer ratings,” she said. “And there is a clear association between getting a prescription for an antibiotic and giving more stars to that clinic when you do the rating.”

“We also have this perversity in the system because a lot of people don’t understand antibiotic resistance — they don’t understand that most of the illnesses they have aren’t responsive to antibiotics,” she added. “They feel better if they receive that prescription, they give another star, and that is driving provider behavior. They want to stay in business and so we have a problem with the entire healthcare system.”

Thomas Heymann, MBA, president and CEO of the Sepsis Alliance, called on Congress to follow the lead of the World Health Organization and the G7, “which have called on all of [their] member nations to establish a National Sepsis Action Plan … On September 11, the Sepsis Alliance called on the Biden-Harris administration to do exactly that, with certain planks attached.”

“We would recommend a plank for antimicrobial resistance to connect those dots, and then a plank for data inspired by the cancer registries that were started in the 1990s that allowed us to really understand the heterogeneity of cancer,” Heymann said.

Part of the issue with antimicrobial resistance is that the general public isn’t aware of the problem, he added. “We did a survey 2 years ago on public knowledge of antimicrobial resistance in the U.S., Brazil, Spain, China, and India. And only 52% of adults had even heard the [phrase] ‘antimicrobial resistance.’ So how can we expect them to be part of the solution if they don’t know what you’re talking about? … It really demonstrated the opportunity we have for education, public awareness, and really making an investment.”

On the other hand, patients need to be listened to more, said Esiason. “Patients have been ‘othered’ — for better or worse — for a long time,” he said. “Patients are seen as people without degrees; they are just people who are implicit benefactors of healthcare delivery, but in fact we’re consumers of healthcare … We can very easily communicate what it is that we need, why we need it, and how we need to get it.”

To that point, patient choice also needs to be considered, Miller said. “When a patient is in the hospital and they’re told they have an infection, they’re generally not told the type of infection that they have. And they’re almost always never asked what choice they would make in the type of treatments that they would get … and hospitals are really disincentivized to offer the latest innovative products that addresses resistance.”

Goldman said that, as a physician, when it comes to selecting antibiotics for her patients, “what I’d really like is not to be faced with a choice … I don’t have available to me a bedside diagnostic, something I can use immediately to know what’s the right drug to use. I have to do it empirically. That is not a great way to practice medicine.”