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Module 4: Facilitating Patient Access
Access to Oral Antivirals (OAVs)
Pharmacy partners are encouraged to
order commercial product to ensure that there is adequate supply to meet demand for oral antivirals.
There should be no gap between depletion of USG-distributed product and commercial product.
Anyone facing difficulty in access at the pharmacy counter should be directed to the patient assistance programs available to support access to
Paxlovid (PAXCESS)
and
Lagevrio (Merck Helps)
.
Through the Paxlovid PAP operated by Pfizer, individuals covered under federal programs, such as Medicare or Medicaid, and uninsured patients have a free access option to Paxlovid through 2024. Eligible uninsured patients have a free access option beyond 2024.
Commercially insured patients can access the co-pay savings program.
Medical professionals, pharmacy and plan partners should take steps to ensure patients understand the full range of options.
Guide patients to enroll
– to ensure little to no cost for patient, encourage enrollment/awareness at every opportunity (eg, prior to pharmacy engagement).
Continued Access to Paxlovid
Medicare, Medicaid, and uninsured patients will continue to receive Paxlovid at no charge
through December 2024 using the USG Patient Assistance Program (USG PAP) operated by Pfizer.
Includes all patients publicly insured through Medicare (with or without Part D, Part B, or Part C and inclusive of Medicare Advantage), Medicaid/CHIP, TRICARE, and patients insured through the VA Community Care Network.
Uses USG-procured supply (commercial, NDA-labeled).
Separately,
federal entities (HRSA, IHS, VA, DoD, others) will have continued access to USG-procured Paxlovid supply for their patients
, similar to how they have accessed Paxlovid to date.
USG-procured Paxlovid may also be used to support state, local, tribal, or territorial
special programs targeting vulnerable populations on a case-by-case basis
.
Reach out to your ASPR regional staff or
covid19.therapeutics@hhs.gov
.
Concurrently, Pfizer is operating a
Paxlovid Co-Pay Savings Program
for eligible privately (commercially) insured patients.
Accessible through
Paxlovid.com
for patients and
Paxlovid.pfizerpro.com
for health care providers or Phone
1-877-C19-PACK
(
1-877-219-7225
) IVR & Live Operator Support.
Continued Access to Lagevrio
The
Merck Patient Assistance Program
(a 501c3 non-profit organization) provides Lagevrio free of charge to patients who meet its eligibility criteria and who, without assistance, could not otherwise afford the product.
This product is
ONLY available through an URGENT NEED request
. Your
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. Your Health Care Provider must follow the program representative's instructions to make your request. You may also check your eligibility on
MerckHelps
.
In addition, USG-procured Lagevrio will continue to be distributed to certain federal entities, including HRSA-supported health centers, Indian Health Service, and others until USG supply is depleted.
CIG Right-Nav
Federal Response to COVID-19: Therapeutics CIG
Introduction
Introduction
Clinical Implementation Guide Objectives
COVID-19 Therapeutics under Emergency Use Authorization (EUA)
COVID-19 Therapeutics: Resources for Health Care Professionals and Public Health Officials
Module 1: COVID-19 Outpatient Therapeutics Overview
COVID-19 Outpatient Therapeutics Overview
Who Is At Risk for Severe COVID-19?
NIH Guidelines For Treatment of Mild to Moderate COVID-19 in Non-hospitalized Adults
NIH: Patient Prioritization for Treatment
Recommendation for Special Populations: Immunocompromised & Pediatrics
Module 2: Products for Treatment of Mild-to-Moderate COVID-19
Products for Treatment of Mild-to-Moderate COVID-19
Paxlovid
Veklury
Lagevrio
Module 3: Oral Antiviral Administration
Oral Antiviral Administration
Patient Flow for Antiviral Oral Therapies
Test to Treat: About the Program
Treatments Locator
Module 4: Facilitating Patient Access
Facilitating Patient Access
Access to Oral Antivirals (OAVs)
Continued Access to Paxlovid
Continued Access to Lagevrio
Module 5: Reimbursement
Reimbursement
CMS Guidance for Oral Antivirals
CMS Resources: Veklury Billing
CMS Resources
Module 6: Product Returns
Product Returns
Inventory and Disposal Management for Transition to Traditional Commercial Distribution
Data Reporting Requirements
Guidelines for Product Return/Disposal
On Site Destruction of Expired or Unauthorized Product
Module 7: Additional Resources
Additional Resources
COVID-19 Vaccination after mAb Administration
For USG Procurement Reporting Guidance
Opting in to the Treatments Locator
Voluntary Reporting of Commercial Therapeutics
COVID-19 Therapeutic Resources
Module 8: Appendices
Appendices
Appendix A: Outpatient Infusion Site Resources
Appendix B: COVID-19 Convalescent Plasma
Appendix C: Formerly-Authorized Products