Citing 'diminishing supply,' Pardee changes eligibility for monoclonal antibody treatment

HENDERSONVILLE, N.C. (WLOS) — Pardee UNC Health Care announced Wednesday, Oct. 6 it is changing the eligibility requirements for patients who can receive the COVID-19 monoclonal antibody treatment, due to a diminishing supply and ongoing demand for the treatment.

Pardee will now require a referral for the highly effective infusion before Day 5 of infection, which cuts the timeframe of eligibility in half. Before this adjustment, the hospital was accepting patients within 10 days of symptom onset.

The change in eligibility comes as a result of the REGEN-CoV supply now being managed at both the state and federal levels, despite Pardee's monoclonal antibody clinic having recently been expanded in order to better meet the demand for the treatment.

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A news release from Pardee stated it is making this adjustment in order to continue to serve the community and manage supply.

“What we’re facing at the moment is a supply issue that simply cannot match the demand for this highly effective treatment,” said Carol Stefaniak, RN, chief nursing officer for Pardee UNC Health Care. “With the distribution of REGEN-CoV now being managed at the state and federal level, we’re experiencing a reduction in supply. Thankfully, we have adequate supply of BAM/ETE in stock and anticipate receiving additional doses in the near future.”

Pardee will utilize both REGEN-CoV and bamlanivimab and etesevimab (BAM/ETE) combination monoclonal antibody infusions depending on supply allocated from the state and federal government. Pardee has been using BAM/ETE for COVID-19 treatment since December 2020.

Like REGEN-CoV, BAM/ETE received Emergency Use Authorization from the FDA for treatment of COVID-19 infection, with similar clinical criteria required. BAM/ETE has also proven effective against the Delta variant still causing the vast majority of COVID-19 infections in the region. As with REGEN-CoV, BAM/ETE has proven to reduce risk for hospitalization and death from COVID-19 infection.

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"Vaccinations remain the optimal choice for anyone who wishes to avoid serious illness as a result of COVID-19. However, if you do become ill as a result of COVID-19 and wish to receive treatment, it is important to seek treatment early," Stefaniak said.

Hospital officials also said that although the state as a whole is seeing a decline in hospitalizations for COVID-19, Pardee seems to be holding steady and not experiencing a consistent decline at this time.

“Given that our community is still experiencing the effects of the Delta variant and we have been very successful in reducing the number of serious infections and hospitalizations in the community, the demand for monoclonal antibody treatment has grown exponentially in recent weeks,” said Dr. Chris Parsons, medical director for Pardee’s Center for Infectious Diseases. “We’re at a point where we must adjust criteria in order to manage our supplies and continue to serve our community and our highest risk patients effectively.”

Parsons said additional restrictions in criteria may have to be implemented if conditions worsen.

In order to be scheduled for the outpatient monoclonal antibody infusion, patients must have 1) a positive COVID test and 2) a referral from a Pardee Urgent Care or primary care provider. The eligibility criteria for the infusion are very specific and must be verified prior to the referral. For questions about these treatments, or to find out more about eligibility, community members can call 828-694-8222.