Therapeutics Information for Providers

Sept. 13

• NC DHHS Bebtelovimab Replacement Program – Since the commercialization of bebtelovimab on August 15th, 2022, NC DHHS has implemented a Bebtelovimab Replacement Program to ensure continued access for patients who are uninsured/underinsured. Providers may request free replacement vials of bebtelovimab via the NC DHHS Bebtelovimab Replacement Request Form. The form asks providers to attest to the total number of individuals they have treated in the prior week (Sunday through Saturday), and of those treated, how many were uninsured/underinsured. Approved requests will receive a quantity of bebtelovimab vials, at no cost, commensurate with the number of patients treated who were uninsured/underinsured. NC DHHS asks that all bebtelovimab providers take advantage of this replacement program. Treatment should not be denied to any patient based on insurance status. For further guidance on ordering the commercially available bebtelovimab, please contact c19therapies@amerisourcebergen.com.

Aug. 5, 2022

• Paxlovid letter to providers about wrong-dose errors: On Aug. 5, 2022, Pfizer sent a letter to healthcare providers about reports of wrong-dose medication errors that have occurred during prescribing, dispensing, and administering Paxlovid. This letter reminds clinicians of the need for individualized dosage adjustments and the availability of two different Paxlovid dose packs. Pfizer also revised the Paxlovid Patients, Parents and Caregivers Fact Sheet to be dispensed with each Paxlovid prescription. The revised Fact Sheet addresses wrong-dose medication errors during patient self-administration and informs patients on how to correctly take Paxlovid.

July 6, 2022

• FDA revises EUA for Paxlovid: On July 6 2022, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Read the full news release. View the revised Paxlovid Fact Sheet for Healthcare Providers.

June 29, 2022

• FDA authorizes revisions to Evusheld dosing: On June 29, 2022, FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval. FDA continues to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed. For further details, please refer to the FDA’s Frequently Asked Questions for Evusheld.

June 8, 2022

• Therapeutics memo to all North Carolina clinicians: Updated guidance for providers about outpatient treatment and prevention of COVID-19 in patients who are at high risk of progressing to severe disease. Key updates include: Statement on limited bebtelovimab availability and expected NC supply to be depleted in August 2022, information regarding COVID-19 rebound, and updated overview of Veklury (remdesivir) since gaining full FDA approval. Read the memo. 

May 24, 2022

• The CDC issued a Health Alert Network (HAN) Health Advisory to update health care providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 rebound.” Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease. Paxlovid treatment helps prevent hospitalization and death due to COVID-19. COVID-19 rebound has been reported to occur between two and eight days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative. A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status. Read the full advisory.

April 25, 2022

• The CDC issued a Health Alert Network (HAN) Health Advisory to update health care providers, public health departments, and the public about the availability and use of recommended therapies for COVID-19 and to advise against using unproven treatments that have known or potential harms for outpatients with mild to moderate COVID-19. For patients with mild to moderate COVID-19 who are not hospitalized and who are at increased risk for severe COVID-19 outcomes, several treatment options, including antiviral medications and monoclonal antibodies, are now widely available and accessible. Read the advisory.

April 21, 2022

• Therapeutics memo to all North Carolina clinicians: Therapeutics are an important tool to protect patients from severe illness from COVID-19. Large supplies of therapeutics, especially oral antivirals, are now widely available and can be utilized for any patient who meets the criteria in the Emergency Use Authorization. In addition, all providers can prescribe therapeutics for their high-risk patients, even if they don’t dispense them. Read the memo. 

April 5, 2022

• The FDA revised the authorization for sotrovimab, a monoclonal antibody treatment. Data show this treatments are highly unlikely to be effective against the Omicron BA.2 subvariant. Therefore, it is not authorized for use in people diagnosed with or exposed to COVID-19 at this time. Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients.

March 7, 2022

• The Office of the Assistant Secretary for Preparedness and Response (ASPR) has developed a partnership with Pharmacy-Based Clinics and Pharmacies serving long-term care facilities (LTCFs) for the direct ordering of oral antivirals up to a specific threshold at locations that provide comprehensive test and treat services onsite and at locations that provide direct access of product(s) to the long-term care communities. These initiatives will reduce barriers to rapid accessibility to treatment for high-risk COVID-19 individuals and expand overall access to these therapeutics. These allocations come from a separate federal cache that will not impact NCDHHS allocations. More information can be found on the ASPR Fact Sheet and the Test to Treat webpage. 

March 2, 2022

• The NIH COVID-19 Treatment Guidelines Panel updated their recommendations for the medications effective against the Omicron variant that can be used as treatment for non-hospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease. The purpose of the most recent update provides clinicians with guidance on the role of bebtelovimab as an additional treatment option for this patient population. Review the full NIH statement and the revised recommended treatment prioritization.

Feb. 24, 2022

• The FDA revised its EUA for Evusheld to double the initial dose to 300 mg of tixagevimab and 300 mg of cilgavimab based on available data indicating that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dosage. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should be contacted as soon as possible to receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab to raise their monoclonal antibody levels. For more information, please review the updated Evusheld EUA Healthcare Provider Factsheet.

Feb. 23, 2022

• The FDA revised its EUA for sotrovimab to update the administration window to within 7 days of symptom onset. The FDA also adjusted infusion times to 15 or 30 minutes depending on the size of the infusion bag. Additionally, the EUA included language allowing the pause of sotrovimab use depending on the predominant variant in a geographic area. For more information, please review the updated sotrovimab EUA Healthcare Provider Factsheet.

Feb. 17, 2022

• Due to lessening supply constraints, NCDHHS has removed its recommendation for patient prioritization to Tier 1, Tier 2 and Tier 3 of the National Institutes of Health (NIH) Guidelines Panel Interim Statement on Patient Prioritization for Outpatient Anti-SARS-CoV-2 Therapies.  This expands patient eligibility to that authorized through the FDA Emergency Use Authorization for each individual product. View the latest NCDHHS Patient Prioritization for COVID-19 Therapeutics.

Jan. 24, 2022 

• The FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab/etesevimab and REGEN-COV. Data show these treatments are highly unlikely to be effective against the Omicron variant. Therefore, they are not authorized for use in people diagnosed with or exposed to COVID-19 at this time. There are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to be effective against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk. View the latest NCDHHS Patient Prioritization for COVID-19 Therapeutics.