The time is ripe to protect Medicare beneficiaries from the AMR pandemic

By Steve Sandor, Vice President, Market Access and Trade, Paratek Pharmaceuticals, Inc.

The “unspoken pandemic” of antimicrobial resistance (AMR) is a major public healthcare crisis with the potential to impact every American. In the U.S., about three million people contract antibiotic-resistant bacterial infections and more than 35,000 people die from these infections each year.[1] Older generic antibiotics that have succumbed to AMR lack the efficacy or durability to treat these infections, a fact which underscores the continuing need for newer antibiotics and a vibrant, thriving antibiotics sector to develop them.

More alarming, while most commercial insurers – that is, those providing care for people typically under 65 years of age – cover newer antibiotics without restrictions, Medicare plans lag behind by giving priority to older, less expensive antibiotics and restricting access to the newer ones that often address the challenges of AMR. This reliance on generic antibiotics for the Medicare population has created a healthcare disparity for some of our most vulnerable citizens and, unfortunately, has put their lives at risk.

Our parents and grandparents, many of whose prescription needs are served by Medicare Part D plans, are uniquely vulnerable to AMR due to their more frequent and prolonged contact with the health care system, chronic disease states that impair immune function, changes to the immune system that come with normal aging, and use of medical devices prone to bacterial colonization.[2] In addition, a Centers for Medicare & Medicaid Services (CMS) internal analysis found that Medicare beneficiaries account for the majority of cases of both new diagnoses of drug-resistant infections and the resulting deaths in hospitals in the United States.[3] Further substantiating the CMS analysis, an independent study concluded that one in five adults with community-acquired pneumonia (CAP) who were treated in the outpatient setting with a guideline-concordant (i.e., generic) antibiotic experienced treatment failure.[4] The same study also found that mortality across all age groups of CAP patients, including individuals older than 65 years, was four times higher when first-line therapy failed. Moreover, among the CAP patients 65 and older, 24.3% who failed treatment died within the subsequent 30 days compared with 7.3% of non-treatment failure.

While CMS authority is constrained by the non-interference clause contained in the Medicare Modernization Act of 2003, current law protects Medicare beneficiaries from discrimination by allowing CMS to require more robust coverage in certain therapeutic classes. Part D plans are required to cover at least two drugs in each therapeutic category or class, but CMS can make the requirement more robust if it appears that a plan is using the coverage requirement as a ceiling, not a floor, in order not to discriminate against beneficiaries with certain conditions.

Beneficiaries do not shop for Part D plans with the knowledge of whether or not they will contract an acute bacterial infection in the upcoming year, CMS could therefore use their authority to protect beneficiaries and make certain our most vulnerable patient population is adequately protected against AMR. Plan choices to cover newer antibiotic agents for the commercial population demonstrates that the plans see clinical value in these products. So why will the plans not cover them for their most vulnerable patients?

CMS is now in the midst of reviewing formulary lists for 2022 from Medicare Part D plans sponsors that serve the Medicare population. CMS is slated to make decisions on these lists prior to open enrollment in the late Fall: if the insurance provider has proposed adding newer antibiotics to its formulary, CMS has the authority to approve that addition; if the insurance provider has not included newer antibiotics on its formulary, CMS could mandate their inclusion.

Within the next few months, CMS has the opportunity to close the gap between commercially insured individuals who have access to newer antibiotics through their employer-provided insurance plans and seniors whose access to newer antibiotics is restricted by Medicare. In so doing, physicians will be able to choose the appropriate antibiotic for each and every Medicare-eligible patient.

Fail-first is failing seniors

Some of the largest Medicare Plans explain that the primary reason they do not cover newer antibiotics is simply cost. Medicare providers have to manage prescription drug coverage on a fixed budget that relies on federal funding each year coupled with low-cost premiums paid into the Medicare system by seniors. They must walk a tightrope which produces a situation where the availability of funds, not the quality of care, seems to be a key driver of formulary coverage decisions.

These budgetary constraints translate into prescription drug formularies that authorize the use of older, cheaper generics first – antibiotics included. If the patient does not respond to the first drug or if the patient’s condition worsens, physicians can seek the Medicare provider’s prior authorization to prescribe another drug by completing paperwork that explains the medical necessity, then waiting two to three days for approval.

This “fail-first” approach to therapy might be appropriate when there are several similarly priced drugs for a chronic condition. In these non-emergency situations, there is often time to switch a patient to another drug if the first required drug is not clinically effective.

However, the fail-first approach is inappropriate for acute bacterial infections, which have rapid disease onset with the potential to cause permanent harm to the patient, such as organ damage or the loss of a limb, or can result in the death of the patient. Therefore, each infection must be treated as if they have a life-threatening condition. This does not necessarily mean treating empirically by giving every patient a newer antibiotic; but it does require administering the right antibiotic to treat the right bug for that patient, at the right time. The “wait and see” approach of prescribing older generic antibiotics first can increase the risk of poor clinical outcomes that could include hospitalization and death in certain patients, especially when AMR infections are involved.

Additionally, some classes of generic antibiotics, such as quinolones, carry extensive safety risks that are particularly worrisome for seniors; others have potentially dangerous interactions with other drugs for co-morbidities that are common among seniors, such as heart disease; and some patients have known sensitivities or allergies to certain classes of generic antibiotics. In fact, because of the risk of toxicity and adverse events associated with fluoroquinolones, a panel of public health and medical experts convened by the PEW Charitable Trusts has recently recommended that alternative but equally effective antibiotics – whenever they are available – should always be favored over fluoroquinolones.[5]

However, until or unless Medicare Plans adopt the panel’s recommendations, physicians must shoulder the administrative burden of seeking the Medicare provider’s approval to prescribe a newer antibiotic. These “administrative exception” approval steps can delay access to the appropriate antibiotic for 24-48 hours.

Meanwhile, the patient’s life hangs in the balance, awaiting the decision of an insurance company based solely on the diagnosis and prescription request. Instead, we should be giving licensed healthcare professionals the authority to make these decisions in a timely fashion for the Medicare patients whom they serve.

?The safety valve of stewardship

Antibiotic stewardship is a valid issue, aimed at preventing over-use of newer antibiotics that could drive AMR and, over time, reduce their efficacy. Stewardship is also frequently used as an argument against giving physicians unfettered access to the antibiotic pharmacopeia. But physicians already understand and practice appropriate antibiotic stewardship; this safety valve is already built into the system. More so than ever before, physicians are reluctant to prescribe antibiotics for any patient with a minor scratch or slight cough and they don’t want to overprescribe the newer ones. Newer antibiotics will not suddenly become blockbuster drugs because physicians are given access to them.

What physicians need is the ability to prescribe the right antibiotic for the right patient at the right time, especially for seniors who are covered by Medicare. We shouldn’t be forcing physicians to start with drugs that might not or will not work in these patients.

For this reason, we urge CMS to require all Medicare Part D plan sponsors to give physicians and their patients unrestricted access to designated QIDP FDA-approved antibiotics, balanced against the appropriate stewardship guidelines that those physicians already follow.

This action would reduce potentially deleterious coverage delays – or outright rejections – that currently prevent physicians from selecting the right antibiotics based on the patient’s condition and the desired clinical efficacy and safety. In turn, it would save the lives of many of our nation’s seniors, who are the most vulnerable to AMR bacterial infections.

[1] https://www.cdc.gov/drugresistance/index.html

[2] Giarratano, A., et al., Review of Antimicrobial Use and Considerations in the Elderly Population. Clin. Interv. Aging 208;13:657-67.

[3] Verma, S. CMS’s ‘expanded pathway’ for new antibiotics can help fight antimicrobial resistance. STAT First Opinion (Nov. 6, 2019).

[4] Tillotson G., et al. Antibiotic Treatment Failure and Associated Outcomes Among Adult Patients With Community-Acquired Pneumonia in the Outpatient Setting: A Real-world US Insurance Claims Database Study. Open Forum Infect Dis. 2020;7(3):ofaa065.

[5] PEW Charitable Trusts. Health Experts Establish Targets to Improve Hospital Antibiotic Prescribing: National data shows inappropriate prescribing, opportunities for improvements. March 18, 2021.