Another day, another study about the failures of the current healthcare market.
According to a recent analysis, drug makers often lose money after developing new antibiotics due to lack of sufficient demand, which discourages such companies from investing additional dollars in the cause. And without new antibiotics, clinicians will have a hard time effectively treating “superbugs” of the future.
The study, led by Cornelius J. Clancy, MD, associate professor of medicine and director of the mycology program and Extensively Drug Resistant Pathogen Laboratory in University of Pittsburgh’s Division of Infectious Diseases, was published in Antimicrobial Agents and Chemotherapy, a journal of the American Society for Microbiology. It focuses on the financial viability of producing new antibiotics to treat one of the world’s most drug-resistant bacteria, called Carbapenum-resistant Enterobacteriaceae (CRE).
The uphill battle against superbugs
Experts estimate CRE infections cause 1.5 to 4.5 million hospitalizations worldwide each year. According to the Centers for Disease Control and Prevention, some CRE bacteria have become resistant to most available antibiotics, making such infections difficult to treat. One report cites a 50 percent mortality rate for those infected. The World Health Organization and CDC classify CRE among the highest-priority pathogens for development of new antibiotics.
Dr. Clancy and his fellow researchers determined that the current U.S. sales of new antibiotics to treat CRE come to about $101 million annually. If prescribers used anti-CRE agents in every applicable situation, the projected market size shoots up to $289 million. But previous research has found antibiotic sales must reach $1 billion to assure the product is financially viable.
“CREs are a poster child [of this problem] — serious infections, high mortality rates, ineffective treatments,” Clancy tells Florence Health. “New drugs have come in to address this, but because of the way the market is set up, these drugs may fail and new developments may be curtailed.”
Drying up the pipeline
The drug development process, according to Clancy, takes 10 to 15 years. For the first time, a few years ago, scientists realized there weren’t enough treatment options in the development pipeline. (For antibiotics, drug makers tend to leave newer drugs on hold in the pipeline until the one in circulation becomes ineffective.)
Since then, the government, along with various public and private organizations, have refocused attention on the future of antibiotic development. But there’s a catch.
“Unless you’re constantly replenishing the pipeline, you’re back to square one,” Clancy explains. “This isn’t something you can just turn on and off. Once you turn it off, you’ve got to spend 10 to 15 years turning it back on and, in the meantime, you don’t have the necessary drugs. It’s an inefficient use of resources, and we’ve got to keep it active.”
A tipping point
Since 2015, the U.S. Food and Drug Administration has approved five new antibiotics against CRE, but only three of them are more effective and less toxic than previous antibiotics. Furthermore, one of the developers of the new anti-CRE drugs, a biopharmaceutical company called Achaogen, declared bankruptcy in April due to steep losses.
Clancy believes we’re at a point where, if nothing changes in the marketplace, it’s possible that companies will no longer pursue antibiotic development.
“We’re at a precarious moment,” Clancy notes. “There’s a real risk that the pipeline over time just dries up. Within a year, the industry could face a pretty big contraction.”
The heart of medicine
Overall, Clancy says society must reexamine how it values antibiotics and upgrade current models for funding healthcare to support the need for antibiotic development.
“There is no cancer chemotherapy unless you can prevent and treat infections,” Clancy emphasizes. “There is no complex cardiovascular surgery unless you can prevent and treat infections. Antibiotics have to be treated by the healthcare system with that in mind and in a way that respects the value they bring to all disciplines.”
What comes next?
Clancy and co-author M. Hong Nguyen, MD, Pitt professor of medicine and director of UPMC’s Antimicrobial Management Program, propose a combination of “push” and “pull” incentives to encourage sustainable antibiotic development, starting with approval of the bilateral DISARM Act, currently under consideration in Congress.
The DISARM Act would improve critical Medicare reimbursement for new antibiotics and require hospitals receiving increased payments for the drugs to monitor their use. It would remove the disincentive hospitals face to use more effective, expensive, and newer agents rather than cheaper, older ones.
The act’s overarching goals are to stabilize the antibiotics market, spur the development of new infection-fighting drugs, establish stewardship programs and preserve the effectiveness of existing medicines.
The bottom line, according to Clancy: Clinicians and hospitals must be more aggressive in using new antibiotics and should push to get them on hospital formularies.
“What people have seen is that five new drugs have gotten approved to treat CRE, and they feel like things are going great,” Clancy said. “I’m worried that there’s a certain complacency, an idea that we’ve got antibiotics coming. But this is not necessarily the case. No matter what discipline you’re in, your ability to practice is going be impacted. A lot of what we do may no longer be possible.”
New Study is ‘Chilling Commentary’ on Future of Antibiotics, University of Pittsburgh Medical Center.
Estimating the size of the United States market for new antibiotics with activity against carbapenem-resistant Enterobacteriaceae, Antimicrobial Agents and Chemotherapy.
Vital Signs: Carbapenem-Resistant Enterobacteriaceae, Centers for Disease Control and Prevention.
Last updated 10/16/19.