Overview
The U.S. Food and Drug Administration (FDA) has approved or issued emergency use authorizations (EUA) for therapeutics for treatment of early mild-to-moderate COVID-19 in high-risk patients:
- The preferred agent at this time is the oral antiviral nirmatrelvir boosted with ritonavir (PAXLOVID) begun within 5 days of symptom onset.
- Similar effectiveness can be achieved with the intravenous antiviral remdesivir (VEKLURY) which requires infusion on 3 consecutive days and must be started within 7 days of symptom onset.
- If neither of these therapeutics is available or appropriate, the oral medication molnupiravir may be given starting within 5 days of symptom onset.
Five previously authorized monoclonal antibodies are no longer authorized due to the presence of variants that reduce their effectiveness: Casirivimab/imdevimab (REGEN-COV), Bamlanivimab/etesevimab, Sotrovimab, Bebtelovimab, and Evusheld.
Use of antiviral IV therapy or oral antiviral medications is not a substitute for vaccination against COVID-19. Everyone is still encouraged to stay up to date with COVID-19 vaccinations.
FDA shelf-life extension
There have been recent changes in shelf-life extensions for several therapeutics. Please be sure to always check the FDA website for the most up to date and product-specific expiration dates. In most cases, the packaging labels do not represent the most current expiration date for that product.
Guidance
- DPH Guidance, November 22, 2022: Paxlovid Treatment Guidance PDF | Doc
- DPH Guidance, February 10, 2023: Guidance for the Use of Therapeutics for Treatment of COVID-19
- This guidance replaces guidance issued by the Department on January 30, 2023, December 5, 2022, November 16, 2022, July 19, 2022, April 26, 2022, April 7, 2022, March 25, 2022, March 7, 2022, February 22, 2022, January 28, 2022, and January 12, 2022.
- DPH Guidance, updated January 28, 2022: Procedures and Requirements for Hospitals/Clinics Dispensing COVID-19 Oral Antivirals
- DPH Guidance, December 16, 2021: COVID-19 Monoclonal Antibody (mAb) Therapy Checklist for Providers
- DPH Guidance, December 16, 2021:Allocation of COVID-19 Monoclonal Antibody Therapeutics to Health Care Providers
- This guidance replaces guidance issued by the Department on October 29 and October 1, 2021
Access
- FDA-approved oral antivirals are widely available via retail pharmacies across the Commonwealth.
- COVID-19 treatments should be considered for all your patients and given to all patients appropriate for treatment.
- This group includes a large percentage of all MA residents eligible due to heart, lung, liver, or kidney disease, diabetes, pregnancy, dementia, cancer, disability, substance use disorder, mental health disorder, age over 65, overweight/obesity and immunocompromised. View the full CDC list of medical conditions.
- PAXCESS Patient Support Program: The U.S. Government (USG) has launched the PAXCESS Patient Support Program to provide cost savings options for individuals who have been prescribed Paxlovid. This program offers two options for patients:
- Pfizer PAXCESS Co-Pay Savings Program for commercially insured individuals and takes just a few minutes to access a copay card online
- The USG Patient Assistance Program (USG PAP - Operated by Pfizer) is available for individuals with Medicare, Medicaid, TRICARE, VA Community Care Network as well as uninsured patients. This can also be accessed by phone: 1-877-C19-PACK (1-877-219-7225) for IVR (interactive voice response) and Live Operator Support.
- Telehealth is available for individuals 12 or older living in Massachusetts who test positive for COVID-19 and are experiencing symptoms. This telehealth service can determine if Paxlovid may be an option. If it is, pickup at a pharmacy or free overnight delivery is available. More at mass.gov/CovidTelehealth.
- This telehealth program will continue at least through June 30, 2024.
Additionally, hospitals and other healthcare providers throughout Massachusetts serve as sites for distribution of COVID-19 therapeutics and will administer remdesivir and dispense oral antiviral therapy.