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

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 once 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.

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 will close 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, 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.

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

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

USG will close 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 be submitted 48 hours ahead so that orders can be placed by 3 p.m. 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:

• Beginning 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 December 31, 2023. It is recommended that returns occur in December to allow time to secure NDA-labeled inventory, for the USG PAP operated by Pfizer to go live, and for commercial payer coverage to be established.
  • For Paxlovid returns, visit Inmar at https://returns.healthcare.inmar.com, email rarequest@inmar.com, or call 800-967-5952.
• 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 FDA. This will ensure that individuals receiving Paxlovid under the USG PAP will have access to the same formulations of Paxlovid available outside of the USG PAP.
• USG PAP operated by Pfizer will be available for eligible patients (Note: Additional information on the PAP and Paxlovid Co-Pay Savings Program will be provided by Pfizer in the coming weeks):
  • Through December 31, 2024, individuals covered under federal programs, such as Medicare or Medicaid, and uninsured patients are eligible for the PAP 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 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 can contact the program vendor at PharmacyNetworkContract102101@assistrx.com.
  • Pfizer will also be 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.
• Any previously distributed USG EUA-labeled supply must be dispensed at no cost to the patient.
• Reporting of USG inventory distributed to providers is required until all delivered product is reconciled for the provider site/central awardee.

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:

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 dispending 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 PAPs are not subject to provider agreement reporting requirements.

USG is working to develop a mechanism for providers to report commercial treatment location data voluntarily into the Therapeutics Locator and/or Test to Treat locator tools. Additional details to follow. Please do not record inventory or dispensing of commercially acquired inventory into HPOP; only USG product should be entered in current HPOP reporting fields.

Programs for Uninsured and Underinsured Individuals

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