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

Updated April 10, 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.

COVID-19 Treatments Transition

The following summary table provides a sequence of events based on OAV manufacturers' commercialization plans.

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 EUA-labeled, USG-procured supply. Paxlovid available for purchase.	Paxlovid (standard and reduced dose packaging)
11/10/2023, 3:00 PM 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, 3:00 PM 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 the Department of Defense (DoD) can continue to order USG supply.)	Paxlovid (standard and reduced dose packaging)
12/15/2023	Ordering paused 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 reopened for HRSA, DoS, IHS, PC, BOP, ICE, and NIH until USG supply is depleted or expires in early 2025.	Lagevrio
03/09/2024	EUA-labeled Paxlovid is no longer authorized for emergency use after March 8, 2024. All EUA-labeled Paxlovid must be returned by March 15, 2024, or disposed. The Paxlovid EUA continues to authorize use of the NDA-labeled Paxlovid for eligible pediatric patients.

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).
• Expired product can be disposed of on site in accordance with all federal, state, and local regulations or returned. For sites that do not have an established returns process, visit www.merckorders.com and select “Return Merchandise” or call the Merck Order Management Center at 800-MERCK-RX (800-637-2579).
• Reporting of USG inventory is required until all delivered product is reconciled for the provider site/central awardee.
• The Merck Patient Assistance Program (a 501c3 Foundation) provides Lagevrio free of charge to eligible patients who, without assistance, could not otherwise afford the product.
• Merck is also operating a Lagevrio Co-Pay Savings Program. Through this program, eligible privately insured patients may save on their out-of-pocket costs for their prescriptions for Lagevrio.

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 to the cutoff date of November 27, 2023. If a provider required additional supply to be responsive to demand after USG transitioned away from that 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.

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 were 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 became eligible to be returned via the Pfizer return process. Returns were accepted through February 29, 2024. All returns needed be initiated by mid-February 2024 to ensure the product was received by February 29, 2024, to be accepted for credit to the federal inventory.
  • The EUA-labeled Paxlovid was only authorized for use through March 8, 2024. All EUA-labeled Paxlovid must be disposed of or returned, regardless of the expiration date. Product can be disposed of on site in accordance with all federal, state, and local regulations or returned for disposal. If your site does not have a standard pathway for product returns, please visit Inmar at https://returns.healthcare.inmar.com for returns information.
• For each course of EUA-labeled Paxlovid with an expiration date of December 2023 or later that was returned and received by Pfizer by February 29, 2024, Pfizer provided the USG with a credit for an NDA-labeled course. A similar "refresh/replenishment" was completed for all USG inventory that had not yet been distributed.
  • These "refreshed" courses now supply a USG PAP operated by Pfizer and to supply federal entities.
  • This "refreshed" inventory includes all current formulations of Paxlovid and will bring in any upcoming formulations that may be developed by Pfizer and authorized or approved by 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 the 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 the Health Partner Order Portal (HPOP) to provide free, USG-procured Paxlovid to their patients.
• On a case-by-case basis, 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 that are unable to access the product through the USG PAP. Any questions can be sent to COVID19.therapeutics@hhs.gov.
• Any distributed USG-procured, NDA-labeled supply must be dispensed at no cost to the patient. Please note that USG-procured, EUA-labeled Paxlovid is no longer authorized for use after March 8, 2024.
• Reporting of USG inventory distributed to providers is required until all USG-delivered product is reconciled for the provider site/central awardee.

Paxlovid	NDC
USG distributed Paxlovid (EUA-labeled) Note: EUA-labeled Paxlovid is no longer authorized for dispensing as of March 8, 2024	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

Providers should use the following guidelines for their inventories of USG-distributed therapeutics:

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 is February 2024. (ASPR searchable expiry database).
	Once expired, product should be disposed of on site in accordance with all federal, state, and local regulations or through the manufacturer's return process. To return to the manufacturer, visit www.merckorders.com and select “Return Merchandise” or call the Merck Order Management Center at 800-MERCK-RX (800-637-2579).
	All disposal or returns of USG-distributed product need to be recorded in HPOP.
Paxlovid (standard and reduced dose packaging)
	As of March 8, 2024, EUA-labeled product is no longer authorized for use. All remaining EUA-labeled Paxlovid, regardless of expiration date, must be disposed of on site in accordance with all federal, state, and local regulations or returned for disposal. Sites that do not have disposal options can contact Pfizer’s returns vendor, Inmar https://returns.healthcare.inmar.com for more information about returns.
	All disposal or returns of USG-distributed product 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 until full reconciliation of 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 note product availability, while non-HPOP users can use the HPOP volunteer reporting website. Sites only need to note that the product is available – not the number of treatment courses – once every 60 days, although more frequent updates provide more accurate information to patients and providers.

Separately, USG-distributed product should continue to be entered in the appropriate HPOP reporting fields.

Patients and health care 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 OAVs for COVID-19 to the commercial market. OAVs 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 OAV for COVID-19 that meets the definition of a Part D drug to their Contract Year 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	The 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. 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	Co-Pay Savings Program	Website: https://www.lagevrio.com/patients/coupon/ Eligible, privately insured patients may pay as little as $10 per prescription, up to a maximum program savings of $300 per patient. Coupon may be redeemed before the expiration date printed on the coupon, on each qualifying prescription up to a 5-day supply.
	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