COVID-19: Outpatient Therapeutic Information for Providers - NYC Health

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COVID-19: Providers

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Information for Providers

COVID-19

Vaccine

Data

Prevention and Groups at Higher Risk

When You Are Sick

Long COVID

Express Testing

Information for Providers


Outpatient Therapeutics

Latest Updates and Advisories

Advisory #2: COVID-19 Treatments Transition to Commercial Distribution (PDF, February 1, 2024)

Update (2/2/24): New York State Medicaid (NYRx) is now covering Paxlovid at no cost to patients. If patients encounter unexpected charges at the pharmacy, they can enroll in Pfizer’s Paxcess program (see below).

FDA revises letter of authorization for the emergency use authorization for Paxlovid (January 29, 2024)

Health Advisory #28: Prescribe COVID-19 Therapeutics to Prevent Severe Disease, Hospitalization and Death This Winter (PDF, November 4, 2023)

Oral Antivirals Moved to Commercial Market

The oral antivirals nirmatrelvir with ritonavir (Paxlovid) and molnupiravir (Lagevrio) have transitioned from U.S. government distribution to the commercial market. Ordering free federal supplies is closed (except for federal entities, including Federally Qualified Health Centers). Any remaining supply of U.S. government-issued therapeutics can continue to be dispensed to patients at no cost until the Emergency Use Authorized product expires on March 8, 2024.

Patients may now encounter out-of-pocket costs for oral antiviral medications. Patient assistance programs have been developed to help ensure uninsured and underinsured individuals have continued and timely access to critical COVID-19 oral antivirals treatments. (See section Patient Assistance Programs below.)

Due to these changes, the NYC Department of Health and Mental Hygiene’s Home Delivery Program using Alto Pharmacy has ended. Alto Pharmacy will dispense commercial Paxlovid and Lagevrio per their routine procedures, including free next day delivery. They are participating in the Pfizer’s Paxcess Patient Assistance Program for eligible patients (see below).

Advise patients to call ahead to confirm availability of the medication at their pharmacy and whether there will be co-pays or other charges and direct them to the patient assistance programs to avoid unnecessary costs or delays in treatment.

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

HHS: Transition of Paxlovid to Commercial Distribution: Frequently Asked Questions

Outpatient Treatments for COVID-19

Antivirals work by targeting specific proteins on the SARS-CoV-2 virus to prevent virus replication within the host cell.

The oral antivirals nirmatrelvir with ritonavir (Paxlovid), molnupiravir (Lagevrio) and the intravenous antiviral remdesivir (Veklury) are available for:

Treatment of symptomatic patients with mild to moderate COVID-19 who are at high risk of progressing to severe COVID-19.

Treatment must be started as soon as possible and within 5-7 days of symptom onset.

Preferred therapies:

Paxlovid is the preferred treatment for most outpatients.

IV remdesivir (Veklury) can be used if Paxlovid is contraindicated.

Oral molnupiravir (Lagevrio) is authorized as an alternative treatment option when Paxlovid and remdesivir are not accessible or clinically appropriate.

See NIH COVID-19 Treatment Guidelines for Non-Hospitalized Adults

For IV remdesivir, patients can visit ExpressCare or call 212-COVID19 (212-268-4319) or 311 for a treatment evaluation and to schedule an infusion appointment if indicated through NYC Health + Hospitals.

Select Outpatient COVID-19 Treatment Resources:

ASPR: COVID-19 Outpatient Therapeutics Clinical Decision Aid

CDC: Interim Clinical Considerations for COVID-19 Treatment in Outpatients

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Patient Assistance Programs

Patient assistant programs have been developed to help ensure uninsured and underinsured patients have continued and timely access to critical COVID-19 oral antiviral treatments.

Counsel your patients on these programs when prescribing antivirals and help them enroll or provide them with the necessary information to do so to avoid unnecessary costs or delays in treatment.

Provider resources and patient education materials can be found at Pfizer: Paxlovid Access.

Currently, most people who have insurance coverage through Medicare will need to enroll in Pfizer’s patient assistance program (Paxcess) to access Paxlovid at no cost through 2024. If they do not enroll, they may have to pay for it out-of-pocket and will not be reimbursed.

Nirmatrelvir/Ritonavir (Paxlovid) Coverage and Access Programs

Uninsured and Medicare/Tricare (through 2024)

Patients must enroll in Pfizer’s Paxcess Patient Assistance Program before picking up their prescription to avoid out-of-pocket costs.

To enroll, the patient, caregiver, provider or pharmacist can visit PAXCESS Patient Portal or call 877-C19-PACK (877-219-7225) to complete a short application.

Once approved, information will be provided on how and where to pick up the prescription. Prescriptions must be filled at a Paxcess participating pharmacy, which can be found at the HHS Treatment Locator.

Patients will not be reimbursed for out-of-pocket costs if they do not enroll in the Paxcess program.

Patients also have the option to request overnight mailing of the prescription via FedEx (Sundays excluded) by calling 877-219-7225.

Medicaid/CHIP (through 2024)

New York State Medicaid (NYRx) now covers Paxlovid at no cost to patients.

Commercial Insurance

Most commercially insured patients are eligible for co-pay assistance via Pfizer’s Co-Pay Savings Program.

Patients can go to Paxcess or call 877-219-7225 to enroll in the Co-Pay Savings Program before picking up the prescription at any pharmacy (not limited to pharmacies enrolled in Pfizer’s Paxcess program).

Patients who have already paid a co-pay for Paxlovid may be eligible for a reimbursement. Information and forms are available at Paxcess.

Molnupiravir (Lagevrio) Coverage and Access Programs

Uninsured

Merck has a Patient Assistance Program available for people without health insurance. Visit Merck Helps: Lagevrio for more information on eligibility.

To enroll patients in the program, a provider must call 800-727-5400 and tell the program representative that they are making an Urgent Need Request for Lagevrio for their patient. The program representative will provide further instructions.

If approved, Legevrio will be shipped overnight to the patient’s address.

Medicaid

New York State Medicaid (NYRx) now covers Lagevrio at no cost to patients./

Prior authorization may be required.<.li>

Medicare and Commercial Insurance

Lagevrio is covered by Medicare Part D and most commercial health plans. Patients should check with their pharmacy and health plan about coverage and co-payment costs. There may be co-pays, and commercial health plans may require prior authorization.

If a health plan does not cover Lagevrio or if the co-pay is high, insured patients may still qualify for the Patient Assistance Program if they attest to special circumstances of financial and medical hardship and their income meets program criteria. Providers should call 800-727-5400 to check eligibility.

Remdesivir (Veklury) Access Programs

Uninsured

For patients treated in the outpatient setting, a Patient Assistance Program is available for people without health insurance. Visit Gilead's Advancing Access Program or call 1-800-226-2056 for more information on eligibility.

Insured

For patients with commercial or private insurance, there is a co-pay program.

The Advancing Access Program can provide support with prior authorization and/or appeals process information.

Information on coverage and patient assistance programs will continue to be updated in the HHS COVID-19 Therapeutics Transition Guide.

Antiviral Products

In clinical trials, antivirals as an outpatient therapy reduce the risk of hospitalization and death by 88% with Paxlovid, 87% with remdesivir, and 30% with molnupiravir. In real-world studies, antivirals significantly reduced the risks of hospitalization and death among high-risk non-hospitalized patients during periods of Omicron and Omicron-variants circulation, including among highly vaccinated populations. (Lin, 2023; Amani, 2023)

Nirmatrelvir with Ritonavir (Paxlovid)

Indication: Treatment

Administration: Oral twice daily for 5 days

Patient Age: 12 years and older

Paxlovid is approved for people ages 18 and older and is available under EUA for people ages 12-17

FDA Fact Sheets:

Paxlovid Approved Label (PDF)

Paxlovid Fact Sheet for Providers (PDF)

Paxlovid Fact Sheet for Patients, Parents and Caregivers (PDF)

Paxlovid Eligibility Screening Checklist for Prescribers (PDF)

Molnupiravir (Lagevrio)

Indication: Treatment

Administration: Oral twice daily for 5 days

Patient Age: 18 years and older

FDA Fact Sheets:

Molnupiravir Fact Sheet for Providers (PDF)

Molnupiravir Fact Sheet for Patients, Parents and Caregivers (PDF)

Molnupiravir Checklist Tool for Prescribers (PDF)

Remdesivir (Veklury)

Indication: Treatment

Administration: Three (3) daily Intravenous infusions

Patient Age: 28 days of age and older

FDA Documentation:

Veklury Label Sheet (PDF)

Manufacturer Website for Patients

Antivirals Eligibility

Antivirals are available for people who are diagnosed with COVID-19, even if they have been vaccinated.

Paxlovid is the preferred treatment for most outpatients aged 12 and older.

Intravenous Veklury (remdesivir) is recommended for patients younger than 12 years of age or for those unable to take Paxlovid.

Lagevrio (molnupiravir) is authorized for use in people ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.

Oral antivirals are available for people who meet all of the following conditions:

Are age 12 years and older and weigh at least 88 pounds for Paxlovid; 18 years and older for Lagevrio (molnupiravir)

Have mild to moderate COVID-19 symptoms

Are able to start treatment within five days of symptom onset

Are not hospitalized due to severe or critical COVID-19 when treatment is initiated

Have at least one risk factor for progression to severe COVID-19, including:

Age 50 years or older, with risk increasing substantially for those 65 years and older

Being unvaccinated against COVID-19

Have a medical condition or other factors that increase their risk for severe COVID-19 illness

Intravenous Veklury (remdesivir) is approved for people who meet all of the following conditions:

Are an adult or pediatric patient (28 days or older and weighing more 3 kg or 6.6 lb)

Have mild to moderate COVID-19 symptoms

Test positive for SARS-CoV-2 on a nucleic acid amplification test or antigen test.

Are able to start treatment within seven days of symptom onset

Are hospitalized or not hospitalized

Have at least one risk factor for progression to severe COVID-19, including:

Age 50 years or older, with risk increasing substantially for those 65 years and older

Being unvaccinated against COVID-19

Have a medical condition or other factors that increase their risk for severe COVID-19 illness

Providers can use HHS's COVID-19 Decision Support Tool (PDF, September 2023) to support their clinical decisions.

Clinical Considerations

Oral antiviral treatment must be administered within five days of symptom onset, but it is most effective the sooner patients begin. Treatment should be offered to any eligible patient at higher risk for severe COVID-19, regardless of vaccination status (Shaw, 2022).

For Paxlovid Only

Paxlovid is the preferred treatment for eligible patients ages 12 years and older.

Contraindications and Precautions

Paxlovid can alter the concentrations of other drugs, so it is important to assess for potential drug-drug interactions. Approved label includes a boxed warning with instructions for prescribers. Several resources are available on steps that can be taken to avoid significant interactions with commonly prescribed medications, such as brief suspension or dose reduction of other medications. Do not prescribe Paxlovid for patients who are taking rivaroxaban or salmeterol; avoid it in patients with severe renal impairment (eGFR <30).

Paxlovid is not recommended for patients with severe kidney (eGFR <30 mL/min) or liver (Child-Pugh Class C) impairment.

Special renal dose packs (Paxlovid 150 mg; 100 mg) are available for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min).

Patients on ritonavir- or cobicistat-containing HIV or HCV regimens should continue their treatment as indicated.

The following resources are available to assess and manage potential drug-drug interactions:

NIH Treatment Guidelines: Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications

Liverpool Drug Interactions Tool, including downloadable phone app

Assessing a patient for treatment with Paxlovid (PDF)

Infectious Diseases Society of America:

Management of Drug Interactions with Nirmatrelvir/Ritonavir: Resource for Clinicians

Paxlovid for Treatment of COVID-19: Considerations for People with HIV and Hepatitis C.

Ontario COVID-19 Science Advisory Table: What Prescribers and Pharmacists Need to Know

The following strategies can facilitate the use of Paxlovid in special populations:

Although Paxlovid is not recommended in patients with a renal function of eGFR <30 mL/min, based on limited data, some groups have proposed dose adjustments in patients with eGFR <30 or on hemodialysis (NIH Treatment Guidelines).

Patients receiving calcineurin and mammalian target of rapamycin inhibitors may be prescribed if a drug interaction expert is available and close therapeutic drug monitoring is logistically feasible (American Society of Transplantation’s statement)

In patients receiving chemotherapy, interactions should be managed with specialist providers. Guidance on managing chemotherapy interactions can be accessed at the FDA EUA fact sheet and the University Health Network/Kingston Health Sciences Centre resource.

For Lagevrio (molnupiravir) Only

Lagevrio should be prescribed for patients ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.

Precautions

Lagevrio is not recommended during pregnancy. Prescribing providers should advise individuals of childbearing potential to use effective contraception correctly and consistently for the duration of treatment and for four days after the last dose of Lagevrio.

Breastfeeding is not recommended during treatment and for four days after the last dose of Lagevrio. A lactating individual may consider interrupting breastfeeding and pumping and discarding breast milk during this time.

Men of reproductive potential who are sexually active with women of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose.

For more information, see the Lagevrio Fact Sheet for Providers (PDF) and the FDA Lagevrio Checklist Tool for Prescribers (PDF).

For Veklury (remdesivir) Only

Veklury (remdesivir) is available for adults and children 28 days and older. It is administered daily for 3 consecutive days via intravenous infusion and treatment should start within 7 days of symptoms onset.

Contraindications and Precautions

Therapy is contraindicated for patients with a history of clinically significant hypersensitivity reactions to its active ingredients or any other components of the product.

Prior to initiating treatment with Veklury, the FDA recommends performing liver function and prothrombin time tests as clinically appropriate and repeating these tests during treatment as clinically indicated.

For more information, see the Veklury Label Sheet (PDF)

COVID-19 Rebound

COVID-19 rebound is the term used describe a recurrence of symptoms or SARS CoV-2 antigen positivity, which can occur between 2 and 8 days after initial recovery. Recent studies suggest that patients who experience rebound have an extremely low probability of developing severe COVID-19. Retreatment is not currently recommended. The potential for COVID-19 rebound after antiviral treatment is not a reason to avoid prescribing.

People with rebound can transmit to others, and patients should re-isolate for at least 5 days from the recurrence of symptoms per CDC guidance. It is important to advise your patients that COVID-19 rebound does not represent a failure of treatment or resistance.

Prescribing Oral Antiviral Therapy

Paxlovid and Lagevrio are available in pharmacies throughout NYC. Visit the federal COVID-19 Treatment Locator to find the nearest location, including pharmacies participating in the Pfizer Paxcess Patient Assistance program. Clinicians should recommend to patients that they call ahead to their pharmacy to confirm availability of their prescribed oral antiviral medication and whether there will be a co-pay or other charges.

Oral antivirals can only be prescribed by a physician, advanced practice registered nurse or physician assistant. Paxlovid can also be prescribed by pharmacists with certain limitations (PDF). For more information on prescribing Paxlovid, see the Paxlovid Eligibility Screening Checklist for Prescribers (PDF) and the Pharmacist Paxlovid Prescribing Guide (PDF).

Access to Intravenous Antiviral Therapy (Remdesivir)

Veklury can be given in skilled nursing facilities, home health care settings and outpatient facilities such as infusion centers as long as severe hypersensitivity reactions, such as anaphylaxis, can be managed.

Visit Veklury HCP for coding and reimbursement information and Gilead Advancing Access for patient assistance resources.

Facilities and providers that see large numbers of immunosuppressed patients (such as transplant and oncology centers), high-risk pediatric populations, or other patients for whom Paxlovid may not be clinically appropriate are encouraged to offer Veklury in the outpatient setting. This can be done in collaboration with tertiary care centers.

Patients can also visit ExpressCare or call 212-COVID19 (212-268-4319) or 311 for a treatment evaluation and to schedule an appointment for remdesivir infusions if indicated through NYC Health + Hospitals.

Patient Education on Antivirals

People at increased risk of severe COVID-19 and their caregivers should be advised:

About the benefits of prompt oral antiviral treatment to reduce the risk of hospitalization and death

To immediately get tested if they develop COVID-19 symptoms or were recently exposed

To contact their provider right away if they test positive

That COVID-19 rebound is generally mild and does not represent a treatment failure or resistance

To develop a COVID-19 action plan (PDF) so that all information needed is on hand if they or a member of their household gets sick with COVID-19

Paxlovid Co-pay Card

Paxlovid Patient Assistance Program (Paxcess) Patient Brochure

Access to Care

Patients who do not have a health provider or are uninsured can be referred to:

NYC Health + Hospitals ExpressCare (212-COVID19; 212-268-4319) for low or no cost treatment and care, including IV remdesivir if indicated for patients unable to take Paxlovid. If patients do not have insurance or cannot afford to pay, they will be connected to financial counselors who can help them enroll in health insurance or financial assistance, reducing or eliminating their out-of-pocket costs. The standard self-pay charge for Virtual ExpressCare telehealth visits is $125.

The federal HOME Test To Treat program for free evaluation and treatment for COVID-19 and flu, if eligible.

Resources for Patients

HHS: What Are Oral Antivirals

COVID-19: When You Are Sick

Paxlovid Patient Assistance Programs (Paxcess) Patient Brochure

Enroll in Paxlovid Co-pay Program (for commercially insured)

Enroll in Paxlovid Patient Assistance Program (for Medicare, Medicaid and uninsured)

Patient Handout: COVID-19 Treatments Are Available (PDF)

Palm Card:Treatment for COVID-19 (PDF)

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اردو

CDC: COVID-19 Personal Action Plan

USPS: Order Free At-Home COVID-19 Tests

Find an NYC Free Testing Site

Provider Resources

CDC: Interim Clinical Considerations for COVID-19 Treatment in Outpatients

HHS: Paxlovid (nirmatrelvir co-packaged with ritonavir) Information Page

FDA: Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers

HHS: Lagevrio Information Page

FDA: Molnupiravir Checklist Tool for Prescribers (PDF)

NIH: COVID-19 Treatment Guidelines

COVID-19 Convalescent Plasma

Infectious Diseases Society of America: COVID-19 Treatment Guidelines

HHS: Clinical Decision Aid (PDF, September 2023)

New York State: COVID-19 Guidance for Medicaid Providers: Coverage and Billing and New York State Medicaid (NYRx) Policy of Commercially Acquired COVID-19 Oral Antivirals

Gilead: Advancing Access Program Offerings to Assist Patients Prescribed VEKLURY