Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program

Updated February 1, 2024
First Published October 20, 2023

COVID-19 Therapeutics Program Background

This guide is intended to provide direction as the U.S. Government (USG) prepares to wind down the current distribution of USG-procured COVID-19 therapeutics and transitions the COVID-19 Oral Antiviral (OAV) treatments (nirmatrelvir packaged with ritonavir [Paxlovid] and molnupiravir [Lagevrio]) to the commercial market. This guide aims to help jurisdictions and providers (1) plan for the transition away from USG ordering; (2) understand the impact of this transition on ordering mechanism; (3) understand how to manage inventory of USG distributed OAV products, including continued reporting requirements for remaining USG inventory; and (4) provide summary information about programs to provide access for uninsured and underinsured individuals as COVID-19 OAVs become commercially available. This guide is for planning purposes only and will be updated as additional details become available.

Winter COVID-19 Treatments Transition

The following summary table provides an estimated sequence of events based on OAV manufacturers' commercialization plan.

Projected Timeline (All subject to change)	Action/Event	Product
10/2/2023	HHS switched Lagevrio threshold/replenishment to a request-based approach using an out-of-cycle (OOC) process.	Lagevrio
11/1/2023	Commercial Lagevrio launch by Merck (unique NDC relative to USG-procured supply). Lagevrio available for purchase.	Lagevrio
11/1/2023	Commercial Paxlovid launch by Pfizer (NDA-labeled, unique NDC relative to Emergency Use Authorization (EUA)-labeled, USG-procured supply. Paxlovid available for purchase.	Paxlovid (standard and reduced dose packaging)
11/10/2023, 3:00PM ET	Last day for awardees to submit orders for Lagevrio USG product (Health Resources and Services Administration [HRSA], Department of State [DoS], Indian Health Service [IHS], Peace Corps [PC], Bureau of Prisons [BOP], Immigration and Customs Enforcement [ICE], and the National Institutes of Health [NIH], can continue to order USG supply).	Lagevrio
11/27/2023	HHS switched from the Paxlovid threshold/replenishment to a request-based approach using an OOC request process. Thresholds for all entities were set to zero. Jurisdictions, federal entities, and other partners can order additional Paxlovid supply from USG by submitting an OOC request.	Paxlovid (standard and reduced dose packaging)
12/15/2023, 3:00PM ET	Last day for awardees to submit orders for Paxlovid USG product. OOC orders are made against OOC requests. Because OOC requests require up to 48 hours to process, requests should be submitted 48 hours ahead of time so that orders can be placed by 3:00 PM ET Dec. 15. (HRSA, DoS, IHS, PC, BOP, ICE, NIH, Veterans Affairs (VA) and Department of Defense (DoD) can continue to order USG supply).	Paxlovid (standard and reduced dose packaging)
12/15/2023	Ordering pause for Lagevrio for HRSA, DoS, IHS, PC, BOP, ICE, and NIH to determine thresholds based on remaining USG inventory.	Lagevrio
11/15/2023 – 2/29/2024	Providers with excess USG-distributed, EUA-labeled Paxlovid are encouraged to return product through the Pfizer returns process to facilitate a credit to USG. All returns should be initiated mid-February, 2024, to ensure the product is received by February 29, 2024.	Paxlovid (standard and reduced dose packaging)
01/08/2024	Lagevrio ordering reopens for HRSA, DoS, IHS, PC, BOP, ICE, and NIH until USG supply is depleted.	Lagevrio
03/09/2024	EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024. After that date, all EUA-labeled Paxlovid needs to be returned or otherwise disposed. The Paxlovid EUA will continue to authorize emergency use of the NDA-labeled Paxlovid for eligible pediatric patients.	Paxlovid

Ordering and Distribution Timelines

Lagevrio (molnupiravir)

USG stopped the traditional threshold/replenishment ordering mechanism for Lagevrio on October 2, 2023, by setting ordering thresholds to zero for all awardees.

USG closed ordering for Lagevrio for all jurisdictions, pharmacy and other partners on November 10, 2023, at 3:00 PM ET. Federal entities other than DoD and VA, can continue to order USG supply beyond November 10. Jurisdictions and other partners should work with their providers/sites to deplete the USG supply in the field and replace inventory with commercial supply as needed.

IMPORTANT On November 1, 2023, Lagevrio commercial product became available for purchase through commercial channels. Partners should manage USG product and the commercial product, with the following expectations:

• USG distributed product inventory should be used until it is depleted or expires or is no longer usable, whichever comes first.
• USG distributed product shall continue to be dispensed at no cost to patient.
• USG distributed product cannot be returned unless expired (first expiry is February 2024); please refer to searchable database to determine product expiry: COVID-19 Therapeutic Product Expiration (hhs.gov).
• Reporting of USG inventory is required until all delivered product is reconciled for the provider site/central awardee.
• As USG supply is depleted, the Merck Patient Assistance Program (a 501c3 Foundation) intends to provide Lagevrio free of charge to eligible patients who, without assistance, could not otherwise afford the product.

Lagevrio	NDC
USG distributed Lagevrio (EUA)	0006-5055-06
Commercial Lagevrio (EUA)	0006-5055-09

Paxlovid (nirmatrelvir packaged with ritonavir; standard and reduced dose packaging)

USG stopped the traditional threshold/replenishment ordering mechanism for Paxlovid products (standard and reduced dose packaging) on November 27, 2023, by setting ordering thresholds to zero for all awardees.

Providers were encouraged to place necessary orders prior the cutoff date of November 27, 2023. If a provider required additional supply to be responsive to demand after USG transitions away from the current mechanism, Paxlovid continued to be available for ordering via the already established OOC request process until December 15, 2023. Requests received after November 27, 2023, were processed as they were received.

USG closed ordering for Paxlovid products (standard and reduced dose packaging) for all jurisdiction, pharmacy and other partners on December 15, 2023, at 3:00 PM ET. Federal entities can continue to order USG product beyond December 2023. Out of cycle orders are made against out of cycle requests. Because out of cycle requests require up to 48 hours to process, requests should have been submitted 48 hours ahead so that orders can be placed by 3:00 PM ET, December 15.

IMPORTANT On November 1, 2023, Paxlovid commercial NDA-labeled dose packs became available for purchase through commercial channels. Partners should manage USG EUA-labeled Paxlovid packaging and the commercial NDA-labeled packaging with the following expectations:

• To ensure maximum value of the USG-purchased inventory, sites are encouraged to return EUA-labeled Paxlovid. As of November 15, 2023, USG-distributed EUA-labeled product with an expiration date of December 2023 or later is eligible to be returned via the Pfizer return process. Returns will be accepted through February 29, 2024. All returns should be initiated by mid-February, 2024, to ensure the product is received by February 29, 2024, to be accepted for credit to the federal inventory.
  • The EUA-labeled Paxlovid is only authorized for use through March 8, 2024. After that date, all EUA-labeled Paxlovid must be returned or disposed, regardless of the expiration date. Information on Paxlovid returns, including to request pre-paid shipping visit Inmar www.PaxlovidEUAreturns.com, email PaxlovidEUAreturns@inmar.com, or call 877-740-6148.
• For each course of EUA-labeled Paxlovid with an expiration date of December 2023 or later that is returned, Pfizer will provide the USG with a credit for an NDA-labeled course. A similar "refresh/replenishment" will also be completed for all USG inventory that has not yet been distributed.
  • These "refreshed" courses will supply a USG PAP operated by Pfizer and to supply Federal entities.
  • This "refreshed" inventory will include all current formulations of Paxlovid and will bring in any upcoming formulations that may be developed by Pfizer and authorized or approved by the FDA. This will ensure that individuals receiving Paxlovid under the USG PAP operated by Pfizer will have access to the same formulations of Paxlovid available outside of the USG PAP operated by Pfizer.
• USG PAP operated by Pfizer is available for eligible patients (Note: additional information on this program and Paxlovid co-pay savings program can be found on Pfizer's Paxlovid website):
  • Through December 31, 2024, individuals covered under federal programs, such as Medicare or Medicaid, and uninsured patients are eligible for the USG PAP operated by Pfizer and can receive Paxlovid at no cost. Health care providers and dispensing locations can provide information to patients regarding eligibility and how eligible patients can enroll in the PAP to obtain free product. Through this program, participating dispensing sites will be reimbursed for any product dispensed, along with a dispensing fee. Retail pharmacies that would like to learn more about participating, can contact the program vendor at PharmacyNetworkContract102101@assistrx.com.
  • Pfizer is also operating a Paxlovid co-pay savings program for eligible commercially insured patients.
• Federal entities can continue to order USG-procured treatment courses through HPOP to provide free, USG-procured Paxlovid to their patients. A limited quantity of additional USG-procured Paxlovid may also be requested in Tiberius using the Request Paxlovid for Targeted Program request form to support state, local, tribal, or territorial special programs targeting vulnerable populations on a case-by-case basis. Any questions can be sent to COVID19.therapeutics@hhs.gov.
• Any previously distributed USG EUA-labeled usable supply must be dispensed at no cost to the patient. Please note that EUA-labeled Paxlovid is no longer authorized for use after March 8, 2024.
• Reporting of USG inventory distributed to providers is required until all delivered product is reconciled for the provider site/central awardee.

Paxlovid	NDC
USG distributed Paxlovid (EUA-labeled)	Carton: 0069-0345-30; 0069-1085-30; 0069-1101-20; Blister: 0069-1085-06; 0069-0345-06; 0069-1101-04
Commercial Paxlovid (NDA-labeled) Note: USG-procured Paxlovid distributed after December 15, 2023, will be NDA-labeled Paxlovid	Carton: 0069-5321-30; 0069-5317-20; Blister: 0069-5321-03; 0069-5317-02

Guidance on Inventory and Disposal Management

It is anticipated that USG will stop the existing ordering mechanism per the aforementioned timeline. Providers should maintain their inventories of USG distributed therapeutics per the following guidelines:

Disposal Management Guidelines
USG Distributed Product	Guideline
Lagevrio	USG product should be dispensed to patients until depletion or expiration, whichever comes first.
	Product cannot be returned/disposed of unless expired (first expiry February 2024, (ASPR searchable expiry database).
	Once expired, product should be disposed of through the manufacturer's return process or on site in accordance with all federal, state, and local regulations.
	All disposal or returns need to be recorded in HPOP.
Paxlovid (standard and reduced dose packaging)	Through March 8, 2024, USG product should be dispensed to patients until provider has commercial supply stocked.
	After March 8, 2024, EUA-labeled product is no longer authorized for use, and all EUA-labeled Paxlovid, regardless of expiration date, must be disposed.
	Undispensed excess supply with an expiration date of December 2023 or later should be returned to Pfizer by February 29, 2024, for a credit replacement to USG inventory of NDA-labeled treatment course: www.PaxlovidEUAreturns.com, email PaxlovidEUAreturns@inmar.com, or call 877-740-6148. All returns should be initiated by mid-February, 2024, to ensure product is received by February 29, 2024, to be accepted for credit to the federal inventory.
	Any non-usable or expired product (Pfizer's searchable expiry data), should be disposed of through the manufacturer’s return process or on site in accordance with all federal, state, and local regulations.
	All disposal or returns need to be recorded in HPOP.

For up-to-date information on expiration dates of all products: ASPR searchable expiry database.

Data Reporting Requirements

In accordance with the COVID-19 Therapeutics Provider Agreement, providers are responsible for adhering to all requirements outlined in the agreement while dispensing USG distributed product. Providers are expected to report 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. USG supply used to support PAP programs are not subject to provider agreement reporting requirements.

USG has developed a mechanism for providers to report commercial treatment location data voluntarily that is now visible in an expanded treatments locator tool. As of November 27, sites can voluntarily upload commercially acquired inventory data for Paxlovid, Lagevrio, and outpatient Veklury via HPOP. HPOP users can leverage their existing accounts to report, while non-HPOP users can report using the HPOP volunteer reporting website. Separately, USG distributed product should continue to be entered in the appropriate HPOP reporting fields.

Patients and healthcare providers may use the ASPR Treatments Locator to search for sites with commercial COVID-19 therapeutics inventory in addition to remaining USG inventory and Paxlovid PAP sites. This website has replaced the Test-to-Treat and Therapeutics Locators.

Reimbursement and Programs for Uninsured and Underinsured Individuals

Individual programs will provide and manage assistance plans to ensure COVID-19 treatments will be available to uninsured and underinsured individuals once COVID-19 therapeutics transition to commercial availability.

On January 4, 2024, with an update on February 20, 2024, the Centers for Medicare & Medicaid Services issued Part D Coverage of Oral Antivirals for COVID-19 in the context of the transition of oral antivirals for COVID-19 to the commercial market. Oral antivirals for COVID-19 that meet the statutory requirements at section 1860D-2(e) of the Social Security Act and are not otherwise excluded from coverage must be covered by Part D plans, either as a formulary product or through the formulary exception process consistent with 42 CFR §423.578(b). Consistent with the November 4, 2022, memorandum CMS continues to encourage Part D sponsors to add at least one oral antiviral for COVID-19 that meets the definition of a Part D drug to their Contract Year (CY) 2024 formulary on a preferred or $0 cost-sharing tier, as available in the plan benefit structure.

Product	Programs	Description and Additional Information
Paxlovid	Co-Pay Savings Program	Co-Pay Savings Program is available for eligible commercially insured patients
Paxlovid	Patient Assistance Program using USG supply	Website: For Patients | https://www.paxlovid.com/ PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets) for HCPs (pfizerpro.com) Tel: 1-877-219-7225 (1-877-C19-PACK) 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. Through this program, participating PAP dispensing sites will be reimbursed for any product dispensed, along with a dispensing fee. For retail pharmacies that would like to learn more about participating in the USG PAP operated by Pfizer, please contact the program vendor at PharmacyNetworkContract102101@assistrx.com. Starting January 1, 2025: Eligible uninsured and underinsured patients can receive USG procured, NDA-labeled Paxlovid at no cost. Through this program, participating PAP dispensing sites will be reimbursed for any product dispensed, along with a dispensing fee.
Lagevrio	Patient Assistance Program	Tel: 800-727-5400 This product is ONLY available through an URGENT NEED request. A health care provider must call 800-727-5400 and tell the program representative that they are making an urgent need request for Lagevrio. The program representative will provide necessary instructions. A health care provider must follow the program representative's instructions to make the request.
	Bulk Replacement Program	Tel: 888-727-8180 Website: merckhelps.com