COVID-19 Therapeutics Update
Process and Logistics Updates
New! HPoP Minimum Order Quantities (MOQ) lowered for Lagevrio and Evusheld
- Effective October 3, 2022, the United States Government (USG) allocation for Lagevrio (molnupiravir) will be reduced for Virginia and the MOQ reduced from 24 doses to 15 doses to offer smaller volume ordering to HPoP providers.
- Additionally, the MOQ for Evusheld will be lowered from 24 doses to 12 doses. The new MOQ of 12 doses equals 6 patient courses. Please note that this change does not impact small volume ordering which still allows for providers NOT in HPoP to order 1 to 3 patient courses.
Now LIVE in HPoP! HHS Bebtelovimab Product Replacement Initiative
The goal of this initiative is to assist with equitable access to commercial Bebtelovimab for under and uninsured patients. As of September 23, 2022, providers that used a dose of commercially purchased Bebtelovimab for the treatment of an uninsured or underinsured patient can request a replacement dose in HPoP.
Guidelines to participate - Provider must:
- Have used all their USG supply acquired through the HHS distribution program.
- Have purchased commercial Bebtelovimab and attest to using a purchased dose for an under or uninsured patient.
- Charge a reasonable administration fee for Bebtelovimab for that patient. Providers should consider waiving or reducing administration fees to amounts similar to the CMS payment rates of $350.50 onsite/$550.50 for at home visit when treating a patient who is under or uninsured.
The replacement dose is only for commercially purchased product and will be replaced with commercial Bebtelovimab shipped directly from the supplier. The replacement dose can be used on any patient regardless of insurance status.
Determining how to access Bebtelovimab for your administration site(s):
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Commercially Purchased Product (direct from AmerisourceBergen)
- For patients with Medicare or Medicaid who have insurance but are not uninsured or underinsured or for patients who can afford treatment without insurance.
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Bebtelovimab Product Replacement Initiative (request to HHS through HPoP)
- For patients who are uninsured or underinsured, once USG supply is depleted, and administered a commercially purchased dose with consideration of administration fees waived or reduced.
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State-Allocated USG Supply (request from VDH in HPoP):
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For patients who are uninsured or underinsured, where USG supply is available and commercial product has not been purchased.
Test to Treat Site Locator Tool Enhancements for Pharmacy Prescribing Paxlovid
On September 14, 2022, enhancements were made to the Test to Treat Site Locator to show sites that offer pharmacists prescribing Paxlovid.
This helps to identify locations where people are able to:
- Get tested and
- If they are positive and treatment is appropriate for them – receive a prescription from a health care provider, and then
- Have their prescription filled all at one location OR at a non-traditional test to treat site where testing and assessment sites are linked with a pharmacy
In addition, the Test to Treat Site Locator shows sites that offer telehealth services and mobile sites. If you find that your site information is not up-to-date, please reach out to the therapeutics inbox at covid19therapeutics@vdh.virginia.gov, and we can assist in getting the information updated for your site.
Clinical Updates
Monoclonal antibody therapeutics activity against emerging variants
- Evusheld retains activity against most prevalent variant, BA.5; potentially loses neutralization activity against BA.4.6, BF.7
- NEW: Updated Evusheld Fact Sheet (as of October 3, 2022)
- Breakthrough infections are always possible-- advise patients, particularly those who are immunocompromised, to have a treatment plan in place and to seek timely medical attention if COVID-19 symptoms occur
- Bebtelovimab maintains potency against all currently circulating variants
- Paxlovid/Lagevrio also expected to retain activity based on preliminary data & sequence analysis; additional data pending
Read the full preprint text here.
September 26, 2022: NIH COVID-19 Clinical Guidelines Update
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Ritonavir-Boosted Nirmatrelvir (Paxlovid): In this revision, the Panel notes that concerns related to SARS-CoV-2 viral rebound, and the recurrence of COVID-19 symptoms should not be a reason to avoid the use of ritonavir-boosted nirmatrelvir. To date, the recurrence of symptoms following the use of ritonavir-boosted nirmatrelvir has not been associated with progression to severe COVID-19. Furthermore, viral rebound and symptom recurrence can also occur in the absence of treatment with ritonavir-boosted nirmatrelvir.
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Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications: The Panel added drugs to Box 1 and Box 2, including Janus kinase inhibitors, anti-orthopoxvirus agents, and conjugated monoclonal antibody products. The Panel also reviewed the updated Emergency Use Authorization fact sheet for ritonavir-boosted nirmatrelvir and incorporated the information into this section.
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Molnupiravir: The Panel notes that there is a lack of definitive data regarding the benefit of molnupiravir in patients who are vaccinated and at high risk of progressing to severe COVID-19. Due to the fetal toxicities that have been reported in animal studies of molnupiravir, the Panel recommends against the use of molnupiravir for the treatment of COVID-19 in pregnant patients unless there are no other options and therapy is clearly indicated. It is not yet known how often SARS-CoV-2 viral rebound occurs after molnupiravir treatment.
Resources and Tools
Link to Sign Up for the Newsletter:
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VDH Therapeutics Website for Healthcare Providers
Check out the VDH Therapeutics webpage! We have a variety of resources and tools for providers. Reach out to COVID19Therapeutics@vdh.virginia.gov for questions, comments, or feedback on information you’d like to see.
VDH Therapeutics Website for the Public
The general public can access information about COVID-19 therapeutics at VDH Protect Your Health: Available COVID-19 Treatments.
COVID-19 Therapeutics Webinars and Open Forum Calls for Providers
VDH is continuing to facilitate webinars and open forums monthly. See below for links to register!
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October 5 VDH Healthcare Provider COVID-19 Therapeutics Webinar: Register here.
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October 19 VDH Healthcare Provider Open Forum with Evusheld focus and guest speaker from AstraZeneca: Register here.
Other resource links:
HHS: ASPR Test to Treat Fact Sheet
Treatment of Monkeypox: Information for Virginia Healthcare Providers
Find where to access therapeutics here.
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