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COVID-19

Therapy for Non-Hospitalized Patients


Updates

  • Transition to Commercialization: As of November 1, 2023 both Lagevrio and Paxlovid Emergency Use Authorization (EUA), US Government (USG) procured supply remaining in the field should continue to be dispensed at no cost to patients. For more information on this transition please refer to the COVID-19 Therapeutics Transition Guide as well as the FAQs.
  • Paxlovid Returns: Providers with excess USG-distributed, EUA-labeled Paxlovid are encouraged to return product expiring December 2023 or later through the Pfizer returns process. These returns must occur by January  31, 2024 and will facilitate a credit to the USG Patient Assistance Program (PAP) operated by Pfizer. 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 Paxlovid returns, visit Inmar at https://returns.healthcare.inmar.com, email rarequest@inmar.com, or call 800-967-5952.
  • Paxlovid Patient Assistance Programs are available for Medicare, Medicaid and uninsured patients. More information on these programs can be accessed at: Paxlovid.com for patients and Paxlovid.pfizerpro.com for providers.
  • A Paxlovid Co-Pay is available for patients with commercial insurance. Information regarding this program is available at: https://www.paxlovid.com/enroll-in-co-pay-program.
  • Lagevrio cannot be returned unless expired (first expiry is February 2024); please refer to the searchable database to determine product expiry: COVID-19 Therapeutic Product Expiration (hhs.gov).
  • 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. Health Care Providers must call 800-727-5400 and tell the program representative that they are making an Urgent Need Request for LAGEVRIO. You may also check eligibility on MerckHelps.
  • All US Govt. supplied product must continue to be inventoried in HPOP until all product has been used, returned or destroyed.
  • HPOP Locator visibility tool for therapeutic providers: In order to improve awarenesss of therapeutic availability by geographic location, providers are encouraged to sign up here.
  • Shelf Life Extensions have been granted for certain lots of Evusheld, Bebtelovimab, Lagevrio and Paxlovid. Click here to check expiry dates for Evusheld, Bebtelovimab and Lagevrio. For updated Paxlovid expiry dates, please visit the Pfizer Paxlovid website here.
Outpatient Treatments for COVID-19

Three antiviral therapies are currently FDA approved or authorized for outpatient treatment of COVID-19 infection and recommended by the NIH COVID-19 Treatment Guidelines Panel. They are not approved for pre- or post-exposure prophylaxis. Importantly, they retain full activity against the current variant mix in California.

Note: The FDA has removed the requirement for a positive SARS-CoV-2 viral test in order to prescribe these medications. Although the agency still strongly recommends the use of viral testing to help diagnose COVID-19 this change allows for providers to consider treatment in the rare instances where an individual with a known exposure who develops signs and symptoms consistent with COVID-19 presents with a negative test. See FDA product specific FAQs for more information.

Antiviral Medication (in order of preference) FDA Status Mode/duration of Administration Start time from symptom onset Age/Weight Fact sheets/FAQs
1. Paxlovid Approved (adults) EUA (age 12-17) Oral twice daily for 5 days ≤5 days Age ≥12 who weigh ≥40kg Providers
Approved label
EUA fact sheet

Patient/caregivers
FAQs
2. Remdesivir Approved IV infusion daily for 3 days ≤7 days Adults and children age ≥28 days who weigh ≥3kg Providers
Patients
FAQs
3. Molnupiravir EUA Oral twice daily for 5 days ≤5 days Adults ≥18 (not recommended in pregnancy) Providers
Patient/caregivers
FAQs
See HHS Side-by-Side Overview of Therapeutics for additional information.
Paxlovid

Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use), given within 5 days of symptom onset, is the preferred treatment for adults and pediatric patients (12 years of age and older weighing at least 40 kg) with symptomatic COVID-19 and risk factors for progression. It is taken orally twice a day for 5 days.

See the FDA Paxlovid approved label/fact sheet (EUA) for detailed prescribing information including.

Most commonly used medications can be safely co-administered with Paxlovid

FDA Paxlovid patient eligibility checklist PDF

HHS Paxlovid website includes prescribing information, FAQs, and other resources for providers and patients.

COVID-19 Rebound - FAQs for patients -explains what rebound is, that it is not caused by taking COVID treatments including Paxlovid, that it is usually mild, and what to do if they think they have rebound.
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Paxlovid Patient Assistance Program (PAP):

  • 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.
  • This 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.
  • 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 email the program vendor at PharmacyNetworkContract102101@assistrx.com.
  • Concurrently, Pfizer is operating a Paxlovid Co-Pay Savings Program for eligible privately (commercially) insured patients.
  • The Co-Pay program is accessible through Paxlovid.com for patients and Paxlovid.pfizerpro.com for health care providers.
  • USG distributed EUA-labeled product with an expiration date of December 2023 or later is eligible to be returned via the Pfizer return process. For each course of EUA-labeled Paxlovid that is returned, Pfizer will provide the USG with a credit for an NDA-labeled course.
  • These "refreshed" courses will supply a USG PAP operated by Pfizer and will also supply federal entities.
  • Returns will be accepted through January 31, 2024.

FDA: Letter of authorization | FAQs on the EUA  | FDA letter: new medication packaging for patients with moderate renal impairment  |  Fact sheet for health providers  |  Fact sheet for patient/caregivers

Other resources: Pharmacist Authority to Prescribe

Remdesivir

Remdesivir (Veklury) is the only treatment approved for children under 12 years of age. It is given as an IV infusion for a total of 3 days initiated as soon as possible and within 7 days of symptom onset.

In clinical trials, remdesivir reduced the risk of hospitalization or death by 87% among high-risk unvaccinated patients with COVID-19 treated within 7 days of symptom onset (Gottlieb, 2021).

Given the emergence of variants resistant to mAbs, providing remdesivir in the outpatient setting may be of particular importance for facilities and providers that see large numbers of immunosuppressed patients such as transplant and oncology centers, or high-risk pediatric populations. Providers are encouraged to order remdesivir to have on hand for patients unable to take Paxlovid.

  • FDA approved for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older weighing at least 3 kilograms) who are:
    • Hospitalized, or
    • Not hospitalized and have mild-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization and death.
      Note: In December 2022, the FDA revised the remdesivir labeling to remove having a positive SARS-CoV-2 viral test result from the indication.
  • For information regarding purchasing or how to access remdesivir, please email remdesivir@amerisourcebergen.com, or call 1-800-746-6273 or reach out directly to your AmerisourceBergen representative.
  • HHS is asking providers who administer outpatient Veklury (remdesivir) to add their infusion site to the COVID-19 Therapeutics Locator in order to improve public awareness and product access. Only information provided by the infusion site will be visible on the locator. Infusion sites can opt out of being on the locator at any time. Infusion sites can learn more and opt into the therapeutics locator here.
  • CMS has created the Healthcare Common Procedure Coding System (HCPCS) code J0248 for reimbursement when administered in an outpatient setting. This code is available for use by all payers and is effective for dates of service on or after December 23, 2021. Additional information is available here.

FDA: Prescribing information | Press release FDA approval for children
Information for providers vekluryhcp.com |
Information for patients wwwwww.veklury.com

Molnupiravir (Lagevrio)

Molnupiravir (Lagevrio) is authorized as an alternative therapy when Paxlovid and remdesivir are not available, feasible to use, or clinically appropriate. It is given as 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days. Treatment started as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.

  • Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis.
  • Due to concern for side effects and decreased risk reduction compared to other available medications, molnupiravir should only be used if other treatments are not available or not clinically appropriate.
  • Guidance is now available on the provider fact sheet for the preparation and administration of molnupiravir via nasogastric and orogastric tube.
  • Several studies have shown a risk reduction in severe disease after molnupiravir treatment with the most significant benefit in those at highest risk or elderly (≥75 years of age). In addition, there is evidence of more rapid symptom resolution and viral load reductions in people treated with molnupiravir. See table below.
  • Use in adults 18 and older only. Not recommended in pregnancy. If the provider and patient choose to use the product during pregnancy, it is advised that the patient be registered in the Merck Pregnancy Surveillance Program.
  • Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir.
  • Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.
  • Providers should carefully review the Fact sheet for health providers before prescribing to ensure that the patient’s condition warrants treatment, that there are no drug interactions, and that there are contraindications to therapy.
FDA Molnupiravir patient eligibility checklist PDF

Lagevrio Patient Assistance Program:

  • 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. Health Care Providers must call 800-727-5400 and tell the program representative that they are making an Urgent Need Request for LAGEVRIO.
  • You may also check eligibility on MerckHelps.

FDA: Letter of authorization | FAQs on the EUA  | Fact sheet for health providers  |  Fact sheet for patient/caregivers

Procuring medication for your patients
  • If you are interested in procuring free USG supplied product as you continue to build out your transition plans to the commercial market, please contact  DPH-Therapeutics@ph.lacounty.gov. If you already receive weekly surveys from the DPH therapeutics team you can also request free USG doses through that process. We will continue to support the provider community while our supplies last. Providers will have to attest that doses will be offered free of charge and that they are not already receiving free doses from other government sources.
  • Commercial products can be obtained through your preferred wholesale distributor.
  • This information is intended for medical providers. Information for the public is available here.
  • Patients who are unable to access oral COVID-19 therapeutics through their own provider or who do not have health insurance can be referred to a Test to Treat program or the DPH Public Health Call Center/Tele-Health service, which provides testing, consultation, and prescriptions. 1-833-540-0473 - open 7 days a week, 8:00 am-8:30 pm.
Resources and contact information

 

Contact Information





Public Health has made reasonable efforts to provide accurate translation. However, no computerized translation is perfect and is not intended to replace traditional translation methods. If questions arise concerning the accuracy of the information, please refer to the English edition of the website, which is the official version.

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