New Antimicrobial Drugs Will Have Limited Impact Without Policy Changes

It’s not every day that the Centers for Medicare and Medicaid Services can address one of the greatest public health challenges of our time through routine rulemaking. But that’s where we find ourselves today.

With its proposed update to the annual Medicare inpatient payment rates for hospitals released last week, CMS has taken an important step toward real and lasting progress in the fight against antimicrobial resistance.

In recent weeks, the severity of the AMR threat has been elevated, once again, to our national attention with reporting on an astonishingly “tenacious” fungus, called Candida auris. It turns out our latest germ foe is “quietly spreading across the globe” because it does not respond to existing antifungal medications.

The real trouble, though, is that C. auris is far from our only enemy in this age of AMR. There’s a growing number of bacterial and fungal infections that prey upon those with weakened immune systems.

According to the Centers for Disease Control and Prevention, each year in the United States, at least 2 million people get an antibiotic-resistant infection. It’s estimated that, of these, approximately 153,000 Americans die from these infections. That’s the equivalent of a jumbo jet crashing to the ground every single day of the year.

Perhaps the harder truth is we are in jeopardy of going back to a time when minor accidents and ailments in healthy people send them to their grave. Over the next 35 years, experts predict 10 million deaths could be caused by AMR worldwide.

How did we get here? Most antibiotics have been around for a long, long time — think penicillin — and they’ve been considered among the greatest medical breakthroughs of all time. But they’ve also been a victim of their own success.

By all accounts, antibiotics have been used too liberally and without enough respect for their intended use. The result has been infections of all different types have developed resistance to the antibiotics we’ve come to rely on.

In recent years, countries around the world have recognized this threat and put action plans in place to address it. In the United States, antimicrobial resistance has been deemed a national priority by the last two presidential administrations.

Without exception, experts agree on two keys to addressing the AMR challenge. First, we must use the antibiotics we have more judiciously. Second, companies need to develop novel antibiotics that work in different ways against ever-changing infections.

No doubt, we need more investment in the development of novel antibiotics if we’re going to save lives that are threatened by AMR. But new medicines only get us part of the way there if our health care reimbursement system unintentionally disincentivizes their use.

Currently, hospitals must bill Medicare for the use of antibiotics under what are called diagnosis-related groups. If an advanced generation antibiotic is clinically appropriate, the hospital receives the same payment regardless of a patient’s risk or clinical profile.

DRGs have been effective at reducing wasteful spending. However, when it comes to antibiotics, DRGs serve to encourage the reliance on old, generic versions that are rapidly losing effectiveness and plunging us deeper into this unprecedented public health crisis.

With authority over how hospitals are reimbursed by Medicare for the treatments they deliver to patients, CMS has an important role to play in our collective effort to change the trajectory of this crisis. Last week, CMS proposed providing hospitals with additional payments for new technologies, including potentially new antimicrobial therapies. If finalized, this new approach would put the focus on the most appropriate antibiotic for each patient and not on the least expensive. This change also makes policy sense as it complements the incentives put in place by the Generating Antibiotic Incentives Now Act of 2012, which instituted regulatory changes that encouraged the development of new antibiotics.

For the small pharmaceutical companies, which are responsible for 80 percent of the innovative antibiotics in development today, this change could be critical. We’ve already seen one innovative company declare bankruptcy. Without effective policy reforms, more could follow, and our collective ability to solve this catastrophe will be severely diminished.

It should be encouraging to all of us that CMS recognizes its role in curbing the enormous public health threat of resistant infections. It’s imperative that we finalize the proposed rule this year. Providing our hospitals with adequate reimbursement for new antibiotic therapies is not only sound policy, it’s lifesaving policy.


Ted Schroeder is a board member of the Antimicrobial Working Group and the chief executive officer of Nabriva Therapeutics.

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