Monoclonal Antibodies For COVID Suffer Access Problems Due To Limited Infusion Reimbursement

Source : 'The Pink Sheet'

Unused supply for the Lilly and Regeneron therapies has policymakers considering Medicare payment changes for providers managing outpatient infusion, but those may require legislation. National Academies of Sciences, Engineering and Medicine committee considers the ‘paradox of unused supply with a relatively scarce product’ and tries to dissect the challenges that may be contributing to the unexpected lack of take-up for the mABs.

A lack of sufficient Medicare reimbursement for some providers managing outpatient infusion of the monoclonal antibody drugs for COVID-19 produced by Eli Lilly and Company and Regeneron Pharmaceuticals, Inc. may be hampering patient access to the limited supplies of the treatments that are available.

Medicare has chosen to reimburse administration of the drugs on par with chemotherapy, with a base payment of $309. But “there’s great concern that this amount may not be adequate, especially for all sites,” according to Duke Margolis Center for Health Policy value-based payment reform research director Marianne Hamilton Lopez.

Lopez spoke to a National Academies of Sciences, Engineering and Medicine workshop on allocating the monoclonal antibody therapies for COVID-19 on 17 December. The session was convened by NASEM’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, which plans to release an expert consultation report on the topic in mid-January.

The reimbursement amount “might be more appropriate in some of the larger health systems that have a capacity to absorb such cost,” Lopez said. “But for those other sites, such as long term facilities, mobile home infusions, these kind of pop-up COVID-19 focused infusion centers, they’re going to be having high costs setting up the new infusion services and … providing a higher intensity of care, as well as the needed additional [personal protective equipment] and personnel, and may not have adequate reimbursement with the $309.”

Furthermore, “there’s a lack of support for longitudinal data collection and analysis of treatment outcomes and that may hinder the risk stratification for new and recently-diagnosed COVID-19 patients,” she pointed out.

The workshop focused on the current challenges involved with administering the drugs, and the unsettling reality that even where the limited supplies are available, only 5% to 20% are being used. US Health and Human Services Secretary Alex Azar told a media briefing on 16 December that the government has allocated more than 330,000 treatment courses to states and territories, and “many states do have product available, even as we have people entering the hospital with COVID.”

Lilly’s single monoclonal antibody drug bamlanivimab and Regeneron’s casirivimab-imdevimab cocktail are both have emergency use authorizations from the US Food and Drug Administration. ("An Oversupply Of COVID Antibody Treatments Multiple Monoclonal Products Raise Potential For Errors" "Pink Sheet" )

The disconnect between the cost of infusing the drugs and reimbursement is contributing to “a reluctance among community-based infusion providers to invest in expanding and using capacity to accommodate these COVID antibody therapies,” National Infusion Center Association president and CEO Brian Nyquist told the workshop.

Management of outpatient infusion of the drugs has been an ongoing concern among government officials. ("Future US Purchases Of Lillys Bamlanivimab Will Depend On Success Of Outpatient Infusion Process" "Pink Sheet" )

Because Medicare is covering the total cost of the drugs, providers do not get involved in purchasing, which is not usually how the “buy and bill” process works for Part B drugs. As a result, they will not get the add-on payment associated with Medicare reimbursement that covers professional services for administration, Nyquist pointed out.

Furthermore, Medicare has not set a payment rate for the one-hour observation period that is required following the one-hour infusion process, Nyquist noted. As a result, the “Medicare payment rate for furnishing these COVID monoclonal antibodies and a two-hour procedure does not cover the cost of coordinating care for those patients, much less justify the risk and opportunity costs associated with either investing in the infrastructure modifications needed to safely integrate COVID positive patients into existing facilities, or building temporary infusion capacity,” he asserted.

“If reimbursement under private, fully insured plans and self-funded employer plans will also be inadequate, it will further disincentivize any additional infusion capacity expansion required to meet the increased demand as patient eligibility expands,” Nyquist concluded.

Asked whether there should be a separate budget system for capital costs that would allow providers to set up the infrastructure they need, Nyquist agreed that “might be an easier source of resource support than trying to adjust the Medicare reimbursement structure, which may require an act of Congress.”

Lopez thought the possibility should be explored but cautioned there is “a lot to be figured out,” such as “Where would that funding come from?” and “How could we define the amount that would be needed?”

Large integrated health care systems such as Kaiser Permanente have also faced challenges in identifying appropriate site of care for administering the monoclonal antibodies, Permanente Medical Group associate executive director Sameer Awsare said.

But limitations in the data supporting the EUAs is also a barrier for some physicians and even patients, he pointed out. Awsare acknowledged the FDA requirements for efficacy data are lower for EUAs and that the EUA process is “sort of the only thing we currently have as these new therapies come out.”

However, “it is really important to have data that shows efficacy,” he emphasized. “The National Institute of Health and the Infectious Disease Society of America are both currently not recommending these antibodies as standard of care. They actually say the level of evidence at best, according to them, warrants a shared decision-making conversation between doctor and patient for a therapy with unknown efficacy.”

As a result, “we’ve had patients, when we’re having the shared decision-making conversations, refusing” treatment, he pointed out. And “we’ve had physicians, and even some of our pharmacy and therapeutics people said, ‘Hey, if this came to our formulary committee, we would probably refuse [to cover] this.’”

Harvey Feinberg, chair of the standing committee, noted that the “paradox of unused supply with a relatively scarce product” has “no clear explanation.” However, it “raises an opportunity” to address some of the challenges discussed as well as to develop more effective means of communicating the value of the drugs to patients, he said. Feinberg is president of the Gordon and Betty Moore Foundation.

By Cathy Kelly