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 the Paxlovid USG PAP operated by Pfizer and the Pfizer Co-Pay Savings Program, enrollment can be completed over the phone or through the PAXCESS Paxlovid portal 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 or reduced-cost Paxlovid treatment course at participating pharmacies. Overnight shipping to the patient's home is also available, which may be useful for patients seeking to fill the Paxlovid prescription at a pharmacy not participating in the USG PAP operated by Pfizer or a pharmacy without Paxlovid inventory. In some cases, people with Medicaid and people with a Part D Medicare Plan may be able to get Paxlovid at no charge directly at the counter without having to enroll in the PAP.

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.

Yes. The transition on November 10, 2023, for Lagevrio and December 15, 2023, for Paxlovid did 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 EUA and to set cost-sharing rules for them as they do for FDA-approved drugs. Commercial 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 OAVs for individuals covered by commercial insurers. These include the Pfizer Co-Pay Savings Program for Paxlovid, the Merck Co-Pay savings Program for Lagevrio, the MerckHelps PAP for Lagevrio, and the continued distribution of USG-procured supply of both OAVs to certain federal entities, such as HRSA-funded health centers and IHS health centers.

Like other dispensing sites, Test to Treat locations that are owned by private companies purchase the oral antivirals through traditional commercial channels once their USG supply is depleted or is no longer usable. The PAP and co-pay programs can be leveraged at these locations, as they can elsewhere, to provide the OAVs 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 for free.

• Tens of thousands of retail pharmacies across the United States are participating in the USG PAP operated by Pfizer.
• Retail pharmacies can learn more about participating in the USG PAP operated by Pfizer by contacting the program vendor at PharmacyNetworkContract102101@assistrx.com.
• Pharmacies participating in the USG PAP operated by Pfizer will be reimbursed for any product dispensed, along with a dispensing fee upon adjudication of the voucher for the USG PAP operated by Pfizer.

Commercial ordering for the two COVID-19 OAVs, Paxlovid and Lagevrio, opened on November 1, 2023. Provider sites are using their usual mechanisms to place commercial orders from wholesalers. Both Paxlovid and Lagevrio are available from multiple wholesalers.

For Paxlovid, FDA updated the EUA indicating that the EUA-labeled Paxlovid is no longer authorized for emergency use as of March 8, 2024, regardless of the labeled or extended expiration date. Providers with USG-distributed, EUA-labeled Paxlovid were encouraged to return product expiring December 2023 or later through the Pfizer returns process by February 29, 2024. HHS received a credit for each EUA-labeled Paxlovid treatment course returned by February 29. The credit is being used to support access to free Paxlovid for publicly insured patients, including Medicare and Medicaid beneficiaries, and uninsured patients through the USG PAP operated by Pfizer. Eligible patients can enroll online.

To ensure maximum value of the USG-purchased inventory, sites were encouraged to return EUA-labeled Paxlovid. 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. In January 2024, FDA updated the EUA indicating the EUA-labeled Paxlovid was no longer authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date. As of March 8, 2024, all EUA-labeled Paxlovid must be disposed of, regardless of the expiration date.

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, any of the government-purchased supply that sites dispense must remain available to patients for free.

Lagevrio: Any expired product, once the current expiration date is confirmed, should be disposed of as soon as expiration is reached. We are not aware of any upcoming shelf-life extensions for Lagevrio. All expired product should be disposed of on site in accordance with all federal, state, and local regulations or through a return process. If your site does not have a standard pathway for product returns, www.merckorders.com and select “Return Merchandise” or call the Merck Order Management Center at 800-MERCK-RX (800-637-2579).

Paxlovid: Any expired product should be disposed od as soon as expiration is reached. After March 8, EUA-labeled product is no longer authorized for use, and all EUA-labeled Paxlovid, regardless of expiration date, must be disposed of on site in accordance with all federal, state, and local regulations or through a return process. If your site does not have a standard pathway for product returns, please visit Inmar at https://returns.healthcare.inmar.com.

This question is directly addressed in the FDA Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment. The EUA for Paxlovid continues to authorize prescribing of NDA-labeled Paxlovid for an individual patient by a state licensed pharmacist for the treatment of mild to moderate COVID-19 in eligible adults and pediatric patients, in accordance with the FDA-approved Prescribing Information or authorized labeling, as applicable, and subject to certain conditions as detailed in the Letter of Authorization and the authorized Fact Sheet for Health Care Providers.

This means that pharmacists can prescribe NDA-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.

USG has developed a mechanism for providers to note voluntarily that they have commercial treatments available. Sites that opt in are visible in an expanded Treatments Locator tool. As of November 27, sites also 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 note product availability using the HPOP volunteer reporting website. Sites only need to note product availability – not the number of treatment courses – once every 60 days although more frequent updates provide accurate information for health care providers and patients.

HHS encourages dispensing locations to provide information on where oral antivirals are available to enable everyone eligible to find the medicines they need.

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

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.

For Medicare beneficiaries enrolled in a Part D plan, COVID-19 OAVs must be covered by the plan, but cost-sharing or other plan coverage rules (like requesting a formulary exception) may apply. People who do not have a Part D plan or who might otherwise face cost-sharing or coverage restrictions can access Paxlovid for free through the Paxlovid USG PAP operated by Pfizer.

Any pharmacy may fill prescriptions for COVID-19 OAVs. Patients should check with their insurance plan and pharmacy to make sure they do not face excess charges. Enrollment in the Paxlovid USG PAP operated by Pfizer ensures zero cost for those eligible, including all Medicare beneficiaries. Some Medicare Part D plans may be participating in the Paxlovid USG PAP operated by Pfizer for no-cost access without patients needing to enroll or take additional action. If patients are presented with an out-of-pocket cost for Paxlovid, patients may still choose to enroll to reduce cost to zero. In some cases, their pharmacy may be able to assist with enrollment.

People with Medicaid coverage can obtain the product from pharmacies using a streamlined process through each state's Medicaid Drug Rebate Program (MDRP). The Paxlovid USG PAP operated by Pfizer is always available for anyone eligible who would otherwise face a cost to obtain Paxlovid. For Medicaid fee-for-service (FFS) programs, Pfizer will calculate a state-specific Unit Rebate Amount (URA) for each state using the "Medicaid paid amount" (including professional dispensing fees) divided by the number of units invoiced for that state. This state-specific URA will then be used to reimburse units invoiced for the states' FFS programs.

The availability of Paxlovid though the PAP does not change the requirement that Medicare Part D plans must cover Paxlovid through the formulary or through a formulary exception, if requested. Medicare Part D plans that contract with Pfizer to facilitate the PAP will add Paxlovid to their formulary and process claims with $0 cost-sharing, eliminating the need for the beneficiary to enroll separately in the Paxlovid USG PAP operated by Pfizer. Paxlovid claims paid by the Part D plan—either by facilitating the Paxlovid USG PAP operated by Pfizer or providing coverage through the plan benefit—will pay a dispensing fee according to the plan and pharmacy's contract terms. If a Part D plan is not contracted with Pfizer to facilitate the Paxlovid USG PAP operated by Pfizer, claims for commercial Paxlovid that is not USG-procured will be processed by the plan according to the plan's formulary and coverage rules. In all cases, Medicare beneficiaries, whether they have Part D coverage or not, can enroll in the USG PAP operated by Pfizer to access no-cost Paxlovid.

Under the American Rescue Plan, Medicaid plans must cover COVID-19 OAVs until the end of the third quarter of calendar year 2024. Medicaid beneficiaries are also eligible for no-cost Paxlovid through the Paxlovid USG PAP operated by Pfizer. HHS has developed a streamlined process using the state's MDRP to assist states during this transition period.

People with Medicaid coverage can obtain Paxlovid from pharmacies using a streamlined process through each state's MDRP. The Paxlovid USG PAP operated by Pfizer is always available for anyone eligible who would otherwise face a cost to obtain Paxlovid. For Medicaid FFS programs, Pfizer will calculate a state-specific URA for each state using the "Medicaid paid amount" (including professional dispensing fees) divided by the number of units invoiced for that state. This state-specific URA will then be used to reimburse units invoiced for the states' FFS programs.