NEW DSHS COVID-19 Therapeutics Webpage
DSHS has a new webpage for COVID-19 therapeutics providers that will serve as the one-stop shop for therapeutics updates and resources. The page includes past DSHS therapeutics communications, product information, ordering guides, FAQs, contact information, and other helpful resources.
BAM/ETE and REGEN-COV Not Effective Against Omicron Variant
Currently, the CDC estimates that Texas and surrounding states (Region 6) have greater than 98% prevalence of the Omicron variant. Bamlanivimab/Etesevimab (BAM/ETE) and REGEN-COV (REG) are NOT effective in the treatment of patients infected with the Omicron variant. All shipments of bamlanivimab/etesevimab (BAM/ETE) and REGEN-COV (REG) have therefore been paused by US Department of Health and Human Services, and both therapeutics products have been temporarily removed from the Vaccine Allocation & Ordering System (VAOS). Sotrovimab remains effective against all variants of concern, including Omicron, but is currently in limited supply.
Providers requesting BAM/ETE and REG as therapeutic options should ensure that there is laboratory evidence that the patient is NOT infected by the Omicron variant. If a provider would like to request a quantity of BAM/ETE and REG to have on hand to treat a patient that is NOT infected by the Omicron variant according to laboratory evidence, please contact DSHS at therapeutics@dshs.texas.gov.
For more information, please review DSHS’ Jan. 3rd email communication, titled “DSHS Update on Monoclonal Antibodies and the Omicron Variant.”
Paxlovid and Molnupiravir Distribution and Use
DSHS has been allocated limited quantities of oral medications Paxlovid and Molnupiravir for treatment of high-risk patients with mild/moderate COVID-19 infection. DSHS has distributed its initial allocation of these two therapeutics; due to limited supply, they are not available for ordering in VAOS at this time. Both medications must be prescribed only within the criteria set by the FDA under the Emergency Use Authorization (EUA). Due to the limited quantity of medication available across the country, the National Institutes of Health (NIH) have created guidelines for Patient Prioritization for Outpatient Anti-SARS CoV-2 Therapies or Preventive Strategies When There Are Logistical or Supply Constraints. Healthcare providers can refer to the maps created by DSHS to determine the pharmacies that will have supply of these medications on hand for distribution to patients (see DSHS Therapeutics).
For more information on Paxlovid, view the Health Care Provider Fact Sheet and FDA FAQ document for Paxloid.
For more information on Molnupiravir, view the Health Care Provider Fact Sheet and FDA FAQ document for Molnupiravir.
Please review DSHS’ Dec. 29th email communication, titled “Recently Authorized Therapeutics for COVID-19,” for further details on these two new oral medications.
EVUSHELD Distribution and Use
DSHS has been allocated limited quantities of EVUSHELD, a monoclonal antibody for pre-exposure prophylaxis for COVID-19 in people who are immunocompromised and who are not expected to mount an adequate immune response to the COVID-19 vaccine. EVUSHELD is not a substitute for vaccination in individuals who have been recommended to be vaccinated but can be used in an individual with a history of a severe allergic reaction to a COVID-19 vaccine and who cannot complete the vaccination series.
DSHS has distributed this monoclonal antibody to sites across the state who care for this population of patients; due to limited supply, EVUSHELD is not available for ordering in VAOS at this time. This monoclonal antibody must be given only within the criteria set by the FDA under the Emergency Use Authorization (EUA).
Due to the limited quantity of this medication available across the country, the National Institutes of Health (NIH) have created guidelines for Patient Prioritization for Outpatient Anti-SARS CoV-2 Therapies or Preventive Strategies When There Are Logistical or Supply Constraints. Health Care Providers can refer to the maps created by DSHS to determine facilities who have been allocated this monoclonal antibody (see DSHS Therapeutics).
For more information on EVUSHELD, view the Health Care Provider Fact Sheet and FDA FAQ document for EVUSHELD.
Please review DSHS’ Dec. 29th email communication, titled “Recently Authorized Therapeutics for COVID-19,” for further details on this newly authorized therapeutic.
New Sotrovimab Reporting Requirements
Beginning January 19, 2022, providers who report directly in HHS TeleTracking will be able to report Sotrovimab.
Reminder: Shelf-Life Extension of COVID-19 Therapeutics Bamlanivimab, Etesevimab
On December 21st, the Assistant Secretary for Preparedness and Response and the Food and Drug Administration announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together. Review this HHS Public Health Emergency (PHE) announcement for more information.
Per DSHS’ December 23rd communication, titled “Pause of bamlanivimab/etesevimab and REGEN-COV,” providers should consider pausing the use of bamlanivimab and etesevimab to patients, unless there is laboratory evidence that they are not an Omicron case. However, providers should be mindful of this shelf-life extension when maintaining their remaining supplies of BAM/ETE under proper storage conditions so that they may be used when the situation changes.
Reminder: COVID-19 Therapeutics Ordering Timeline
The deadline for placing an order request in this cycle for COVID-19 monoclonal antibody (mAb) therapeutics is Thursday at 5:00 p.m. Central Time.
Allocation considerations are based on weekly allocation cycles. A new allocation cycle begins every Friday. For your request to be considered for the upcoming cycle, your order must be placed in VAOS no later than Thursday, January 13th, by 5:00 p.m. Central Time. Any requests received after Thursday at 5:00 p.m. will be considered for the following allocation cycle.
Please note that if you are not allotted any therapeutics in a given allocation cycle, you must submit another order request the following cycle; requests are not “carried over” from one week to the next.
Expert Tip: Phone Support for COVID-19 Therapeutics Patients, Providers
Therapeutics providers should encourage patients to direct their therapeutics-related questions to (877) 541-7905 or 2-1-1 Texas, the nurse support line for the public. Nurse support line staff are trained to answer patient questions about facilities that offer COVID-19 therapeutics as well as specific product inquiries.
Kindly note that the provider support line, (833) 832-7068, is only able to answer questions for healthcare providers. Please refrain from referring individual patients to this number, as its representatives can only provide answers to healthcare providers.
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