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Pemgarda (pemivibart) injection for intravenous use

PEMGARDA™ AUTHORIZED FOR EMERGENCY USE

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Invivyd Patient Savings Program

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Invivyd Patient Savings Program

Help your patients access financial assistance for PEMGARDA™

We understand the cost of medicines may be a concern for many patients. That’s why we developed the INVIVYD Patient Savings Program to help your eligible patients get started on PEMGARDA as soon as possible.

  • PEMGARDA has not been approved, but has been authorized for emergency use by FDA under an EUA, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg); and
  • The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Your eligible* patients can enroll in 1 of 2 ways

  • 1 Call 888-550-4883 between 8:30 AM–8:00 PM ET Monday through Friday
  • 2 Sign up by following the instructions on the Invivyd Patient Savings Portal

Patient Eligibility Requirements

Program participation is limited to patients who are eligible to be prescribed PEMGARDA. Patient must have been prescribed PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19 at the time the prescription is filled and administered to the patient. Patient must have commercial health insurance that provides coverage for some portion of the cost of PEMGARDA.

Complete Terms and Conditions

INVIVYD Savings Program Eligibility Criteria, Terms, and Conditions

Program: This savings assistance program is offered by Invivyd, Inc. (“Invivyd”) to support eligible patients who have been prescribed PEMGARDA (pemivibart) and have commercial insurance covering PEMGARDA. PEMGARDA is an investigational medicine that is authorized for use for pre-exposure prophylaxis to help prevent COVID-19 in certain adults and adolescents 12 years of age and older who otherwise meet the eligibility criteria to be prescribed PEMGARDA.

Terms and Conditions: By using the PEMGARDA Savings Program (hereafter, the “Program”), the patient acknowledges that they understand, currently meet, and will comply with all the Terms and Conditions listed below as a condition of their participation in the Program.

Use of Program Data: Data related to patient participation in the Program may be collected, analyzed, and shared with Invivyd, for market research and other purposes related to assessing Invivyd’s patient support programs. Data shared with Invivyd will be aggregated and de-identified and will not identify the patient.

Patient Eligibility Requirements: Program participation is limited to patients who are eligible to be prescribed PEMGARDA. Patient must have been prescribed PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19 at the time the prescription is filled and administered to the patient. Patient must have commercial health insurance that provides coverage for some portion of the cost of PEMGARDA.

Program Restrictions: Program participation is limited to residents of the United States, Puerto Rico, and U.S. territories. Cash-paying patients are not eligible to participate in the Program. Use of the Program is not permitted for prescriptions reimbursed under Medicare, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD), Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), TRICARE®, or other federal or state health programs (such as medical assistance programs). Cash discount cards and other non-insurance plans may not be used in connection with this Program. If the patient is eligible for drug benefits under any of the above listed programs, the patient cannot participate in this Program. By participating in the Program, the patient certifies that they will comply with any requirements of their insurance provider to notify the insurance provider of the existence and/or value of the Program. The patient should not participate in the Program if their insurer or health plan prohibits use of manufacturer savings assistance. It is illegal to (or offer to) sell, purchase, or trade any benefit offered under this Program. The savings are not transferable and are limited to 4 uses per calendar year. Void where prohibited by law. Program managed by IQVIA on behalf of Invivyd.

Program Terms: Invivyd reserves the right to rescind, revoke or amend the terms of this Program without notice at any time.

To the Patient: To access the Savings Card, you must be 12 years of age or older and have a valid prescription for PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19. Follow the dosage instructions given by your doctor. The Savings Card may not be redeemed for cash. By using the Savings Card, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions described herein. The Program is not health insurance and is not conditioned on any past or future purchases. Patients with questions about the Program should call 888-550-4883.

To the Provider or Pharmacist: When you apply the Savings Card to a patient’s prescription, you are certifying that you have (i) not submitted, and will not submit, a claim for reimbursement under any federal, state, or other governmental programs for the prescription, and have (ii) confirmed the patient is 12 years of age or older and have been prescribed PEMGARDA (pemivibart) for pre-exposure prophylaxis of COVID-19. Your participation in this Program must comply with all applicable laws and regulations as a healthcare provider. By participating in this Program, you are certifying that you will comply with the Terms and Conditions described herein.

Patient Consent to Allow Savings Program Payment to Healthcare Provider: The Patient, or the Legal Guardian of the Patient, authorizes the Invivyd Patient Savings Program (hereafter, the “Program”) to:

  • Provide payment directly to the healthcare provider, and not the patient, for out-of-pocket drug cost when the healthcare provider submits the copay claim.
  • Allow the healthcare provider to contact the Program on the Patient’s behalf to initiate payment for services after they have been rendered.
  • Understands that they will be responsible for any out-of-pocket expenses for PEMGARDA if (1) the healthcare provider does not request payment within 180 days from the date of service, or (2) if they are deemed ineligible for reimbursement from the Program.

The Patient understands the above information and gives consent for the healthcare provider to submit and receive payment claims at their direction.

Note: If your healthcare provider is willing to submit your copay claims on your behalf and you wish them to do so, please provide them with your copay identifier information. Your healthcare provider cannot conduct any activity on your behalf unless you direct them to do so and provide your copay identifier information.

The Patient, or the Legal Guardian of the Patient, hereby attests to the following:

  • 1 Commercial Insurance: They have commercial health insurance in effect and will utilize this insurance as the primary payer for my healthcare expenses.
  • 2 No Government Insurance: They are not currently enrolled in any government insurance programs, including Medicare, Medicaid, Medigap, VA, DoD, CHAMPUS, TRICARE®, or other federal or state health programs.
  • 3 Copay Program Eligibility: They understand that this copay program is intended to supplement, not replace, their existing commercial insurance coverage.
  • 4 Accurate Information: They certify that the information provided in this attestation is true and accurate to the best of their knowledge.

Please note: Misrepresenting insurance coverage may result in ineligibility for the Invivyd Savings Program. Invivyd understands that your personal and health information is private and will only use your information in accordance with our Privacy Policy found at https://invivyd.com/privacy. The information you provide will only be used by Invivyd and parties acting on its behalf to send you the materials you requested as well as other helpful products and/or related product information, disease state information, offers, and services.

The Patient, or the Legal Guardian of the Patient, has read and acknowledged the above privacy statement.

The Patient attests to having 1 of the following medical conditions:

  • Active treatment for solid tumor and hematologic malignancies.
  • Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia).
  • Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy.
  • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy).
  • Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome).
  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV).
  • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, and biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents).

The Patient, or as the Legal Guardian of the Patient, agrees to receive communications from Invivyd, the Invivyd Patient Savings Program and/or parties acting on Invivyd’s behalf to determine eligibility and provide benefits verification, prior authorization/appeals assistance, and financial assistance resources and information, such as copay assistance, and for other non-marketing purposes such as, but not limited to, medication updates and dosing reminders.

  • The Patient, or as the Legal Guardian of the Patient, agrees to be contacted by Invivyd, the Invivyd Patient Savings Program, or parties working on Invivyd’s behalf for these purposes through email or by using an autodialer or prerecorded voice at the telephone number(s) provided.
  • If the Patient is an eligible minor or an adult under the care of a guardian, they have also agreed to receive such communications from Invivyd, the Invivyd Patient Savings Program, and/or parties acting on their behalf for the purposes described above, and hereby give permission for Invivyd, the Invivyd Patient Savings Program, and/or parties acting on their behalf to contact the caregiver or guardian for such purposes.
  • The Patient, or as the Legal Guardian of the Patient, understands that they (and, if applicable, my caregiver) can opt out of these communications at any time by contacting Invivyd Patient Savings Program, 888-550-4883.
  • The Patient, or as the Legal Guardian of the Patient, agrees to receive communications described above.

*Mailing address available upon enrollment from the portal or call center (888-550-4883).

Important Safety Information Expand

WARNING: ANAPHYLAXIS

  • Anaphylaxis has been observed with PEMGARDA in 0.6% (4/623) of participants in a clinical trial.
  • Anaphylaxis was reported during the first and second infusion of PEMGARDA.
  • Anaphylaxis can be life-threatening.
  • Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis.
  • Administer PEMGARDA only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary.
  • Clinically monitor individuals during the infusion and for at least two hours after completion of the infusion.
  • Discontinue PEMGARDA immediately if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.

CONTRAINDICATIONS

PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with PEMGARDA. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy. Clinically monitor individuals during infusion and observe for at least two hours after infusion is complete.

Risk of Cross-Hypersensitivity With COVID-19 Vaccine

PEMGARDA contains polysorbate 80, which is in some COVID-19 vaccines and is structurally similar to polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines. For individuals with a history of severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to PEMGARDA administration.

Risk for COVID-19 Due to SARS-CoV-2 Viral Variants with Substantially Reduced Susceptibility to PEMGARDA

Certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA. PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. Inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 viral variants that exhibit significantly reduced susceptibility to PEMGARDA. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.

ADVERSE REACTIONS

The most common adverse events (all grades, incidence ≥2%) observed in participants who have moderate-to-severe immune compromise treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. PEMGARDA should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Lactation

There are no available data on the presence of PEMGARDA in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PEMGARDA and any potential adverse effects on the breastfed infant from PEMGARDA.

Pediatric Use

PEMGARDA is not authorized for use in pediatrics less than 12 years of age or weighing less than 40 kg. The safety and effectiveness of PEMGARDA has not been established in pediatrics.

See full Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers for examples of medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination, the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. The FDA Letter of Authorization is also available for reference.

The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events* and medication errors potentially related to PEMGARDA within 7 calendar days from the healthcare provider’s awareness of the event, using FDA Form 3500 (for information on how to access this form, see below). The FDA requires that such reports, using FDA Form 3500, include the following:

  • Patient demographics and baseline characteristics (e.g., patient identifier, age or date of birth, sex, weight, ethnicity, and race).
  • A statement “PEMGARDA use for the pre-exposure prophylaxis of COVID-19 under Emergency Use Authorization (EUA)” under the “Describe Event, Problem, or Product Use/Medication Error” heading.
  • Information about the serious adverse event or medication error (e.g., signs and symptoms, test/laboratory data, complications, timing of drug initiation in relation to the occurrence of the event, duration of the event, treatment required to mitigate the event, evidence of event improvement/disappearance after stopping or reducing the dosage, evidence of event reappearance after reintroduction, clinical outcomes).
  • Patient’s preexisting medical conditions and use of concomitant products.
  • Information about the product (e.g., dosage, route of administration, NDC #).

Submit serious adverse event and medication error reports using FDA Form 3500 to FDA MedWatch using one of the following methods:

  • Complete and submit the report online: www.fda.gov/medwatch/report.htm
  • Complete and submit a postage-paid FDA Form 3500 and return by:
    • Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
    • Fax to 1-800-FDA (332)-0178, or
  • Call 1-800-FDA (332)-1088 to request a reporting form.

In addition, please provide a copy of all FDA MedWatch forms to:

Invivyd, Inc.
Email: pv@invivyd.com
Or call Invivyd, Inc. at 1-800-890-3385 to report serious adverse events.

The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory responses to requests from FDA for information about serious adverse events and medication errors following receipt of PEMGARDA.

*Serious adverse events are defined as:

  • Death
  • A life-threatening adverse event
  • Inpatient hospitalization or prolongation of existing hospitalization
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • A congenital anomaly/birth defect
  • Other important medical events, which may require a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly

You may report side effects related to Invivyd, Inc. products by sending an email to medinfo@invivyd.com.