Update on Therapeutics for COVID-19 in Idaho, Including Monoclonal Antibodies and Antivirals for Treatment and a Monoclonal Antibody Product for Pre-exposure Prophylaxis.

Dear Provider,

As you know there has been a rapidly changing situation with the arrival of the Omicron variant into Idaho, new information about lack of effectiveness of some currently utilized therapeutics against the Omicron variant, and the availability of new therapeutics.

The local public health districts and Idaho Division of Public Health are coordinating with federal partners to ensure Idaho patients will have access to newly available therapeutics as they become available. The prevalence of the Omicron variant in Idaho still appears to be low among people currently seeking treatment, and as of today, certain patients at high risk of severe outcomes from COVID-19, who present with COVID-19 related illness, but are not hospitalized, are eligible for monoclonal antibodies at various clinics and treatment centers throughout the state, as before. However, in the coming days as the Omicron variant becomes more prevalent in Idaho a few changes will occur, as outlined in this information we received today from the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR):

Circulating SARS-CoV-2 viral variants, including Omicron, may be associated with resistance to monoclonal antibodies. Health care providers should review the Antiviral Resistance information in the Healthcare Provider Fact Sheet for each authorized therapeutic for details regarding specific variants and resistance. The CDC publishes information about circulating variants in the United States by region. The frequency of the Omicron variant is increasing throughout the U.S. and health care providers should refer to these frequency data as they choose a therapeutic option for their patients.

FDA updated the health care provider fact sheets for bamlanivimab and etesevimab administered together, REGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant (B.1.1.529/BA.1). These data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant.

Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun. An additional 300,000 doses of sotrovimab will be available for distribution in January.

ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the mAb therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available.

Information on the authorized products for the treatment of mild-to-moderate coronavirus and other authorized products for treatment or prevention of COVID 19 are available on FDA’s Emergency Use Authorization Drugs and Non-Vaccine Biological Products webpage.

In addition, we expect to receive by next week a limited supply of two newly authorized antiviral
medications allocated to Idaho for use in persons at high risk of severe disease as outlined in the
following Emergency Use Authorization Fact Sheets:

• Molnupiravir: https://www.fda.gov/media/155054/download
• Paxlovid: https://www.fda.gov/media/155050/download
  

As these antivirals arrive in Idaho, we will send updates listing locations where they are available, and instructions on how to work with receiving pharmacies to ensure supply is available.

Lastly, a monoclonal antibody combination product, EVUSHELD, will soon be available in limited supply for pre-exposure prophylaxis in certain patients. EVUSHELD is indicated for persons:

• Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to
  an individual infected with SARS-CoV-2 and either:
  • have moderate to severe immune compromise due to a medical condition or receipt of
    immunosuppressive medications or treatments and may not mount an adequate immune
    response to COVID-19 vaccination or
  • vaccination with any available COVID-19 vaccine is not recommended due to a history of
    severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or
    COVID-19 vaccine component(s).

Given the severely constrained supply, we expect EVUSHELD will initially be prioritized for highly
immunocompromised individuals.

We will notify you once these products are available in Idaho.

Thank you for your patience as we work to get information to you in a timely manner, while much is
changing daily. Please contact us if you have any questions.

Locations offering Monoclonal Antibody Treatment in PHD4
Direct COVID Care
3115 Sycamore Dr, Boise, ID 83703
Call/Text: 208-850-7886
Fax: 208-867-4462

Saint Alphonsus Health System

208-367-DOCS (3627) for questions and referrals

Patients meeting eligibility for mAb treatment presenting with illness to the emergency department or
urgent care locations will be evaluated and connected to an appointment.

St. Luke’s Health System (treatment available in Boise, Meridian, Nampa, Mountain Home, McCall,
Fruitland, Hailey and Twin Falls)
Scheduling call: 208-706-0646
Orders fax: 208-706-5136

*Long Term Care Facilities may contact
Red Rock Pharmacy, Meridian, ID 208-288-1200
Connect Pharmaceuticals, Eagle, ID 208-593-0133