San Diego Union-Tribune

LET’S ASK PATIENTS ABOUT THE VALUE OF ANTIBIOTIC­S

- BY MICHAEL DUDLEY Dudley, doctor of pharmacy, is CEO of Qpex Biopharma. He lives in Escondido.

I have a friend who was recently diagnosed with Stage 4 pancreatic cancer, with evidence of spread to the lungs and liver.

Thankfully, he was quickly referred to a local cancer center with a high degree of expertise. His oncologist chose to use a new drug, as his markers suggested it may help in fighting his cancer. But he was told that insurance had not authorized its use in his case.

This didn’t stop him. “I don’t care — it’s the right drug,” he said to his caregivers. “I will pay for it. Where do I sign?”

This essay is not about cancer drugs, or advocating that patients pay for them. I’m writing about antibiotic­s — and how people should feel the same way about getting potentiall­y life-saving antibiotic­s as they do about oncology treatments. My friend had means and time to consider his options and valued receiving the right drug so much that he was willing to pay as much as tens of thousands of dollars for it.

But that isn’t the case for many patients with lifethreat­ening bacterial infections, where a delay in receiving active antibiotic­s equals an increased risk of death or failure to fully recover. In many hospital settings, patients are often given the oldest, leastexpen­sive antibiotic­s first because capped payment systems don’t leave room to spend money upfront on modern antibiotic­s. Instead, patients often have to “earn” them by failing treatment or experienci­ng toxicity to cheaper antibiotic­s.

We don’t prioritize giving patients the best drug early enough.

It’s time that we pay for antibiotic­s based on their value to patients’ lives, and as a result, ensure patients get the right drug at the right time. In contrast to many older agents developed decades ago, recently developed antibiotic­s have had their safety and efficacy rigorously studied under modern guidance by the U.S. Food and Drug Administra­tion. Yet many older agents remain entrenched because their activity is considered good enough, even though that assessment is often made using outdated laboratory definition­s of antibiotic resistance, and thus creates misplaced confidence in effectiven­ess. Quite frankly, old antibiotic­s are often still used because they’re cheap. While the cost of using newer agents is often the reasoning for sticking to the older agents, the cost for a course of therapy with even modern antibiotic­s is a fraction of the cost of a modern cancer drug.

Properly defining the value of antibiotic­s matters for multiple reasons, beginning with the public health challenge of securing investment­s for infectious disease treatments, and ending with how we reimburse them. This is not a new concept — this debate has been ongoing for the better half of a decade, with foundation­s and academic, industry and government groups calling for different ways to fix this ongoing (and mounting) issue. And yet despite these attempts, policy makers and payers aren’t making progress.

That leads me to the initial question posed in this essay: How do we determine the value of antibiotic­s? Ask a patient.

Let’s put the patient back at the center of the narrative. This is how we will ensure they have access to the treatments they need, just as my friend was willing to do during his cancer journey. There are an increasing number of patients

The cost for a course of therapy with modern antibiotic­s is a fraction of that of a modern cancer drug.

who painfully cycle through countless antibiotic courses for weeks or months because they are not given the proper treatment right away. There is frequent discussion of poor antibiotic prescribin­g practices and “misuse,” but perhaps the most unapprecia­ted and egregious form of antibiotic misuse comes from not using the right antibiotic when it can make a timely impact on a patient’s medical course, and a new antibiotic is finally used after multiple failures with ineffectiv­e drugs. As many studies have shown, sometimes cycling to the “right” antibiotic is often too late.

In reforming drug reimbursem­ent, let’s not forget that the antibiotic pipeline is thin because of poor mechanisms that hurt patients. The DISARM Act is under considerat­ion by the U.S. Congress that could help hospitaliz­ed patients access new antibiotic­s. We provide patients better choices for their treatment course — and often a better one, just as my friend understood. Let’s ensure that we include “patient” in the assessment of the value and stewardshi­p of antibiotic­s.

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