COVID-19 Therapeutics Transition to Commercial Distribution: Frequently Asked Questions

The enrollment process for the PAPs operated by Pfizer (Paxlovid) and Merck (Lagevrio) are designed to be easy for patients and providers with minimal input requirements.

For Lagevrio, the Merck PAP (a 501c3 non-profit organization) anticipates the time to determine if a patient is eligible for the program to be 10 to 20 minutes.

For the Paxlovid USG PAP and the Pfizer Co-Pay Savings Program, enrollment can be completed over the phone or through the website by the patient, a caregiver, a health care provider, or the pharmacist at the point of care. To enroll, the person completing the application must provide both patient and prescribing health care provider information, and the application will confirm the patient’s insurance status; there are no income eligibility requirements. Upon enrollment, which is anticipated to take approximately 5 minutes, the patient is provided an electronic voucher that can be exchanged for a free Paxlovid treatment course at participating pharmacies. Overnight shipping to the patient’s home will also be available, which may be useful for patients seeking to fill the Paxlovid prescription at a pharmacy not participating in the USG PAP or a pharmacy without Paxlovid inventory.

Yes. The transition on November 10 for Lagevrio and December 15 for Paxlovid will not change the ability of certain federal entity partners, including HRSA-supported health centers, to order free USG-acquired product. Please refer to the Therapeutics Transition Guide for additional details. State health officials will continue to have visibility into sites within their jurisdiction that continue to order USG-procured supply.

Federal law does not require commercial plans to cover all possible COVID-19 treatments or put any limits on patient cost-sharing for any commercial plans if the treatments are covered. Plans generally have discretion to cover medicines under Emergency Use Authorization (EUA) and to set cost-sharing rules for them as they do for drugs approved by the U.S. Food and Drug Administration (FDA). Plans in the individual and small group markets must offer some antiviral coverage, although not all antivirals may be covered. In such a case, enrollees may request access to non-formulary drugs through an exceptions process, including on an expedited basis. 

There are programs intended to ensure continued access to COVID-19 oral antivirals for individuals covered by commercial insurers. These include the Pfizer Co-Pay Savings Program for Paxlovid, the MerckHelps PAP for Lagevrio, and the continued distribution of USG-procured supply of both oral antivirals to certain federal entities, such as HRSA-funded health centers and Indian Health Service health centers.

Like other dispensing sites, Test to Treat locations that are owned by private companies will use the USG-purchased product they have in stock and then purchase the oral antivirals through traditional commercial channels. The patient assistance and co-pay programs can be leveraged at these locations, as they can elsewhere, to provide the oral antivirals at little to no cost to eligible patients.

Some Test to Treat locations that are federally supported, such as HRSA-supported health centers, can continue to leverage the HHS supply of Lagevrio and Paxlovid.

• Pfizer is currently working with their program vendor to discuss participation in the USG PAP operated by Pfizer with many of the retail pharmacies across the United States.
• Retail pharmacies can learn more about participating in the USG PAP by contacting the program vendor at PharmacyNetworkContract102101@assistrx.com.
• Pharmacies that are participating in the USG PAP will be paid a dispensing fee upon adjudication of the USG PAP voucher.

Commercial ordering for the two COVID-19 oral antivirals, Paxlovid and Lagevrio, opened on November 1, 2023. Provider sites can use their usual mechanisms to place commercial orders as product moves to wholesalers. HHS anticipates that wholesalers and distributors will be ready to fulfill orders within 1 to 2 weeks and both Paxlovid and Lagevrio will be available from multiple wholesalers, although specific timelines for availability may vary.

For Paxlovid, providers with excess USG-distributed, EUA-labeled Paxlovid are encouraged to return product expiring December 2023 or later through the Pfizer returns process by December 31, 2023. This return will facilitate a credit to USG to support the USG PAP operated by Pfizer. Pfizer will refresh the USG-purchased supply through 2028, ensuring that the USG inventory of Paxlovid is not expired and that it includes new formulations of Paxlovid authorized or approved for use in the United States. We encourage all providers to maximize use of the USG-distributed supply, particularly to ensure distribution channels, payment systems, and the USG PAP operated by Pfizer are fully operational before returning EUA-labeled Paxlovid.

For Lagevrio, dispensing sites should use the USG-purchased supply in their inventory through its depletion or until expiry, whichever comes first.

For both treatments, the USG-distributed supply can continue to be leveraged for any eligible patient so long as the individual EUAs are still active and the product is not expired. Any of the USG-purchased supply that sites dispense must remain available to patients for free.

Lagevrio: Lagevrio is not currently eligible for return as none of the USG-distributed Lagevrio has reached expiration; current expiration dates are February 2024 through February 2025. We are not aware of any upcoming shelf-life extensions for Lagevrio.

Paxlovid: Any expired product, once current expiration date is confirmed, should be returned as soon as expiration is reached. We are not aware of any upcoming shelf-life extensions for Paxlovid.

In addition, Paxlovid with an expiry of December 2023 or later (including non-expired Paxlovid) can be returned by December 31, 2023, to receive a replacement credit to USG inventory for use in the USG PAP operated by Pfizer. Questions regarding costs associated with return shipping should be directed to Pfizer. For all Paxlovid returns, visit Inmar (https://returns.healthcare.inmar.com), email rarequest@inmar.com, or call 800-967-5952.

This question is directly addressed in the FDA Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment. As part of that response, please note the clarification that the EUA does not place any limitation on the presentation of Paxlovid to be dispensed (EUA-labeled Paxlovid or NDA-labeled Paxlovid) when pharmacist prescribing is consistent with the conditions in the EUA letter of authorization. This means that pharmacists can prescribe either NDA-labeled or EUA-labeled Paxlovid within those conditions. The letter of authorization also enables the use of NDA-labeled Paxlovid for patients ages 12 to 17 when prescribed under the conditions of the EUA.

HHS is looking into ways to make commercially available COVID-19 treatment dispensing locations, including sites that continue to offer Test to Treat services and participating USG PAP sites operated through Pfizer, available on a locator tool. We will have more information on that in the coming weeks.

We ask that dispensing locations continue to provide information on where oral antivirals are located to enable everyone eligible to find the medicines they need.

Paxlovid is eligible for 340B pricing, if it is for commercial use, as a covered outpatient drug as defined at section 1927(k)(2) of the Social Security Act.

Lagevrio has an EUA and is not eligible for 340B pricing as it is not a covered outpatient drug as defined at section 1927(k)(2) of the Social Security Act.