Therapeutics Information for Providers

This page is for health care providers. Looking for information about what to do if you feel sick?

Latest Updates

June 3: Final COVID-19 Therapeutic Product Reconciliation

As the U.S. Department of Health and Human Services (HHS) is no longer distributing therapeutics, except to certain federal entities, all providers that received HHS-procured COVID-therapeutics are asked to finalize their reporting data in HPOP. 

All delivered products must be accounted for as administered, transferred, wasted, returned, or on-hand inventory by June 14, 2024. Get more information and guidance for reporting in HPOP in this email distributed to all therapeutics providers on June 3.

View Previous Updates

Product Summaries

Brand Name Also Known As Approved or Authorized Indication Prioritization Fact Sheets or Package Inserts Site Finder Patient Assistance Program
Paxlovid Nirmatrelvir / Ritonavir, Pfizer Authorized for treatment of mild-to-moderate COVID-19 in patients ages 12 and older  who are at risk for progressing to severe COVID-19 and/or hospitalization within 5 days of symptoms (FDA approved for ages 18 and older)  First line treatment option Paxlovid Prescribing Information HHS/ASPR Find COVID-19 Medications

Pfizer Co-pay Savings Program  

US Government Patient Assistance (USG PAP)

Lagevrio Molnupiravir Authorized for treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization within 5 days of symptoms  Alternative oral antiviral for patients for whom neither Paxlovid nor Veklury  are clinically appropriate or feasible 

Molnupiravir  
Provider Fact Sheet

Molnupiravir  
Patient Fact Sheet

 

HHS/ASPR Find COVID-19 Medications

MerckHelps
Veklury Remdesivir Approved for treatment of mild to moderate COVID-19 in high-risk patients ages 28 days and older weighing at least 3 kg within 7 days of symptoms  First line treatment where Paxlovid is not appropriate  Veklury Prescribing Information HHS/ASPR Find COVID-19 Medications Gilead’s Advancing Access

 

Paxlovid Clinical Resources

Recent Updates

Tab/Accordion Items

State Health Director and Chief Medical Officer Dr. Tilson has issued an updated COVID-19 Treatment Provider Memo highlighting two important messages for all NC clinicians:

  • As of March 9, 2024, EUA-labeled Paxlovid is no longer authorized for emergency use, and only NDA-labeled Paxlovid can be dispensed moving forward.
  • Despite this change, all patients, regardless of insurance status, can continue to have access to Paxlovid at little to no cost through the PAXCESS Patient Support Program.

Read the memo for more information on how to provide low-cost COVID-19 treatment to your patients.

The FDA has made an update to the Paxlovid Emergency Use Authorization (EUA) stating that the EUA-labeled Paxlovid distributed by the U.S. government (USG) will remain authorized for use only through March 8, 2024, regardless of the labeled or extended expiration date. 

Sites are encouraged to return all EUA-labeled Paxlovid to help USG earn a credit for use in the USG Patient Assistance Program. The program will provide free, NDA-labeled Paxlovid for Medicare, Medicaid and uninsured patients. The deadline to return EUA-labeled Paxlovid has been extended to Feb. 29, 2024.

As a reminder, commercial NDA-labeled Paxlovid is widely available for purchase through wholesalers.

Ordering for government-distributed oral antivirals closed Dec. 15, 2023. Paxlovid and Lagevrio are available commercially through wholesalers.

Using/Returning USG-distributed Product

  • Paxlovid: Providers are encouraged to follow the Paxlovid returns process to return excess product expiring December 2023 or later. Return by Jan. 31, 2024, to help USG earn a credit for use in the USG Patient Assistance Program. The program will provide free, NDA-labeled Paxlovid for Medicare, Medicaid and uninsured patients.
  • Lagevrio: Use until depleted or expired, whichever comes first.

More information: COVID-19 treatments transition operational guide

COVID-19 oral antiviral treatments, Paxlovid and Lagevrio, will be available for commercial purchase on Nov. 1, 2023. The current government distribution process will continue beyond Nov. 1 for both products to allow the commercial pipeline to mature and ensure there are no gaps in access. To prepare for the transition of these products from a government-managed distribution process to traditional commercial distribution, the U.S. Department of Health and Human Services has prepared a COVID-19 treatments transition operational guide with target dates and detailed information for each step in the transition process.

Staying up to date with vaccines and timely access to treatment are the best ways to reduce hospitalization and death due to COVID-19. This memo provides updated guidance for healthcare providers about outpatient treatment of COVID-19 and includes key treatment messages, information about product accessibility, and an overview of treatment options. Read the memo.

Have questions? We're here to help. 

Contact the Testing and Therapeutics team at covid19testingandtreatments@dhhs.nc.gov.