Oral Antivirals

Oral antiviral treatment works by targeting specific proteins on the SARS-CoV-2 virus to prevent efficient virus replication within the host cell.

Paxlovid and molnupiravir reduce the risk of hospitalization and death by 88% and 30% respectively, in patients at high-risk for severe COVID-19 when started early after symptom onset.

As of November 1, 2023, COVID-19 antivirals, Paxlovid and Lagevrio (molnupiravir), will begin their transition from United State Government distribution to traditional commercial channels. Please refer to the Commercialization section for more information regarding this transition. 

The FDA authorized two oral antivirals, Pfizer's Paxlovid and Merck's molnupiravir, for the treatment of COVID-19 in certain patients who:

• Have tested positive for COVID-19 and have had symptoms for 5 days or less.
• Are at high risk for progression to severe COVID-19, including hospitalization or death.
• Meet certain criteria depending on the antiviral.

The FDA also expanded approval of Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing who are:

• Hospitalized, or
• Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Health care providers should discuss the risks and benefits of treatment with their patients.

As of November 1, 2023, both Lagevrio and Paxlovid will begin their transition from United States Government distribution to traditional commercial channels. Wholesale distributors anticipate having commercial orders filled within one to two weeks. 

Any supply of U.S. government-issued therapeutics, including Paxlovid, must remain available to patients at no cost. Paxlovid should be dispensed to patients until the provider has commercial supply stocked. Moreover, Lagevrio should be dispensed to patients until depletion or expiration, whichever comes first. Once commercialized, programs will be established to ensure that Paxlovid is available to uninsured and underinsured individuals. Please refer to the Programs for Underinsured and Uninsured Individuals section for more information regarding these programs. 

Paxlovid Product Return Process 

From November 15th to December 31st, 2023, providers with excess USG-distributed, EUA-labeled Paxlovid are encouraged to return product through the Pfizer returns process. For Paxlovid returns, visit the healthcare returns management website, email [email protected], or call (800) 967-5952. Product returned to Pfizer will facilitate a product credit to the USG to ensure expired product is replaced. A credit is given only for product with an expiration date of December 2023 or later.  

Any expired product should be disposed of through the manufacturers return process or on site in accordance with federal, state, and local regulations.  

Paxlovid Disposal Management 

Any expired product should be disposed of through the manufacturers return process or on site in accordance with federal, state, and local regulations.  

Lagevrio Disposal Management 

Product cannot be returned or disposed of unless expired (first expiry is in 2024). Once expired, product should be disposed of through the manufacturers return process or on site in accordance with federal, state, and local regulations.  
 

USG Inventory Reporting  

In accordance with the COVID-19 Therapeutics Provider Agreement, providers are expected to continue to provide reporting of all USG courses that they received and should report inventory, administration/dispensing, and disposal data until the provider’s USG product inventory is fully reconciled. Please do not record inventory or dispensing of commercially acquired inventory into HPOP, only USG product should be entered into current HPOP reporting fields.  

Paxlovid and Lagevrio Expiry  

The USG-procured supply has a distinct National Drug Code from the commercial EUA-labeled supply. The first lot expiry of government purchased Paxlovid began on July 31st, 2023, and most in field is later. The first lots of government purchased Lagevrio will begin expiring in February 2024 and the last in February 2025. Please continue to check the ASPR searchable expiration database for specific expiration dates.  

Resources 

For more information regarding the commercialization of Paxlovid, please refer to the COVID-19 Therapeutics Commercialization Transition Guide. 

Paxlovid Patient Assistance Program (PAP) 

Through December 31, 2024, anyone uninsured or covered by federal programs, such as Medicare or Medicaid, can receive USG procured, NDA-labeled Paxlovid at no cost through the USG PAP operated by Pfizer until 2028. Participating PAP dispensing sites will be sent replacement product for any dispensed product within this program.  

Starting January 1, 2025, eligible uninsured and underinsured patients can receive USG procured, NDA-labeled Paxlovid at no cost. Participating PAP dispensing sites will be sent replacement product for any dispensed product within this program. 

For retail pharmacies that would like to participate in the Patient Assistance Program, please contact the program vendor at [email protected] or call 1-877-219-7225.  

Paxlovid Co-pay Savings Program  

A co-pay savings program will be available for eligible commercially insured patients. More information will be provided shortly.  

Lagverio Patient Assistance Program  

This private and confidential program provides medicine, free of charge, for up to one year to eligible individuals, mostly the uninsured, who, without our assistance, could not afford needed Merck medicines. This program is expected to begin mid-November, 2023. For more information, please refer to the Merck Patient Assistance Program brochure or call 1-800-727-5400.  

Lagevrio Bulk Replacement Program  

 For more information on the bulk replacement program, please call 1-888-727-8180. 

HHS has created two resources to assist providers: 

• A COVID-19 Therapeutics Locator which can be used to find locations with available Paxlovid or Molnupiravir. 

• A Medication Locator which can be used to find Test to Treat locations and pharmacies to fill COVID-19 prescriptions. 

• If you are within New York City, please refer to: COVID-19: Outpatient Therapeutic Information for Providers - NYC Health 

Patients will require a prescription for Paxlovid and molnupiravir (Lagevrio). 

If you test positive for COVID-19 and do not have a regular health care provider, you can find a treatment provider using the COVID-19 therapeutics locator. 

Until December 15, 2023, Paxlovid can be requested in the HPOP system. After these dates, Paxlovid ordering in HPOP will be disabled. In the meantime, if you have any issues ordering COVID-19 therapeutics, please email [email protected] with your requested amount included and we can work on requesting additional Paxlovid courses to fill your demand. 

Important: please take this opportunity to update your Stock and Administration in HPOP. 

Requests for oral antiviral product should be submitted through the HHS Health Partner Order Portal (HPOP) as per the following directions: 

1. Sign in to HPOP. 

2. Navigate to the "Site Orders/Inventory" page. 

3. Click on one of the buttons in the upper right corner, "Create an External Order" or "Create Order." 

4. Select a response product type. In this case, click on the "COVID-19 / Therapeutic" button (in red). 

5. Select your response product: Paxlovid, Renal Paxlovid. 

6. Select the desired quantity of the product you are requesting. 

7. Complete your order. 

If you are having trouble accessing or navigating the HPOP system, please reach out to HPOP support at [email protected]. 

If you do not have an HPOP account, please follow the steps below. 

• Complete the COVID-19 Therapeutics Provider Enrollment Form within the Health Commerce System (HCD) here: https://mabrequest.health.ny.gov/nysmab/newprovider 
  • If you do not have a HCS account, please visit the Health Commerce System website, and click on "Don't have an Account? Sign Up Here" to register for an account. 
• The New York State therapeutics team will review your enrollment form and will notify you if your form has been accepted, your form has been rejected, or if there is any other information needed from you to move forward with enrollment. 
• If accepted, the COVID-19 therapeutics team will send an email confirmation that you can log into the HPOP system and begin requesting COVID-19 therapeutics. 

For immediate need of COVID-19 therapeutics, please contact your local pharmacy. 

Reminder: All COVID-19 Oral Antivirals are currently distributed by the government and are available at no cost. 

Step One – Complete the COVID-19 Therapeutics Provider Enrollment Form

Complete the form located within the Health Commerce System (HCS) here: https://mabrequest.health.ny.gov/nysmab/newprovider. 

Step Two – Create HPOP Account 

Once the Department has reviewed and approved your application, they will initiate the creation of an account on your behalf in the HHS Health Partner Order Portal (HPOP) system. You will receive a registration link via email from [email protected] with instructions to begin setting up your account. This link will expire within 72 hours, so it is important that registration is completed in a timely manner.

Step Three - Additional Information for HPOP Account

After registering, the following actions need to be taken in your HPOP account:

• Verify address. If your site is listed as a hub, please send your address, hours, and pharmacy contact (if different) to [email protected]. All hub addresses need to be verified by the state.
  • There is a checkbox below this field for receiving address which must be selected.
• Verify business hours.
  • There is a checkbox below this field for hours verified which must be selected
• Enter license number and expiration date (Ex. BoP, medical license, etc.).
• Select provider type and settings(s) where your facility will administer products
• Select the Therapeutics Category ‘Antiviral’ in your account

Step Four – Request Oral Antivirals

Once you’re HPOP account is active, you should follow the process outlined in the “Request Oral Antivirals” section to place orders.

Please contact the COVID-19 Therapeutics team at [email protected] if you have any questions and/or concerns.