www.margenzahcp.com
Full Prescribing Information

Assistance options for patients who have been prescribed MARGENZA

Copay Assistance Program for patients with commercial insurance

The MARGENZA Copay Assistance Program for commercially insured eligible patients

Offers eligible patients financial assistance with their out-of-pocket costs related to MARGENZA

Program will pay for the entirety of the commercially insured eligible patient’s remaining cost share, including coinsurance and copays for MARGENZA, up to a maximum of $26,000 during a 12-month period.

To enroll in the MARGENZA Copay Assistance Program, you and your patient will need to complete the Copay Assistance Enrollment Form.

Eligibility requirements

Patients must have been prescribed MARGENZA and have commercial insurance that covers their prescribed medicine, but their insurance does not cover the full cost; that is, they have a copay or coinsurance obligation. The brand and the prescription being filled must be covered by the patient’s commercial insurance plan. Offer excludes full cash-paying patients. This offer may not be redeemed for cash.

The patient must not be participating in any state or federal healthcare program including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, Veterans Affairs (VA), CHAMPUS, Department of Defense (DoD), TRICARE®, or any state patient or pharmaceutical assistance program, or wherever prohibited by law. Patients who move from commercial insurance to a state or federal healthcare program will no longer be eligible. Patients who start utilizing their government coverage during their enrollment period will no longer be eligible for the program. Uninsured and cash-paying patients are NOT eligible for this program. Cash Discount Cards and other non-insurance plans are not valid as primary insurance under this offer. If the patient is eligible for drug benefits under any such program, the patient cannot use this offer. This program cannot be combined with any coupon, certificate, voucher, or similar offer.

The patient must be 18 years of age or older and receiving MARGENZA for an FDA-approved use, and a resident of the United States or Puerto Rico.

How to enroll

Patient enrollment instructions

To have an insurance verification completed to determine your patient’s cost share/responsibility under their insurance coverage for MARGENZA:

  • Have the patient complete part 1 on page 2 in the Patient Enrollment section, including all insurance information, or provide copies of his or her insurance and prescription card(s)
  • Have the patient read the Patient HIPAA Authorization on page 4 AND sign and date page 4 where “Signature of Patient” is located
    • To enroll in MARGENZA Access Support Services, the patient must sign and date PATIENT ENROLLMENT PART 3 on page 3

For commercially insured patients who would like to apply for Copay Assistance to offset their cost share for MARGENZA:

  • Ensure that the patient completes the sections needed for an insurance verification in addition to part 2 of the Patient Enrollment section AND sign and date PATIENT ENROLLMENT PART 2 on page 2

Prescriber enrollment instructions

To process the requested services, MARGENZA Access Support will require one prescriber signature.

  • On page 5, complete all sections in the Prescriber Enrollment section
    • The prescriber must manually sign and date the form
  • Complete and fax the form to 1-844-256-5226
Submitting claims

Prescribers who have their patients enrolled in the MARGENZA Copay Assistance Program can submit MedxClaims to receive reimbursement.

  • To submit a MedxClaim, the MARGENZA Access Support Program needs a completed CMS-1500 or UB-04 form, plus an Explanation of Benefit (EOB) letter from the patient’s insurance company that shows a remaining cost share
  • If the patient has secondary/tertiary insurance, an EOB letter from each policy will also need to be submitted
  • If the MedxClaim is approved, you will receive an Explanation of Payment (EOP) and reimbursement (check) via US Mail. Your patient will also receive an EOB letter via US mail
  • If the MedxClaim is denied, MARGENZA Access Support will reach out to advise your office of the denial

The MARGENZA Copay Assistance Program covers the cost of MARGENZA only; it does not cover infusion or administration fees.

Download Form

When complete, fax form to 1-844-256-5226.

Patient Assistance Program for uninsured patients

The MARGENZA Patient Assistance Program

MARGENZA Access Support offers a Patient Assistance Program (PAP) to help qualifying patients obtain MARGENZA at no cost.

Cash-paying patients who are uninsured may be eligible for the PAP. Under that program, patients who meet financial eligibility and other requirements can receive a free year’s supply of MARGENZA.

To enroll in the MARGENZA Patient Assistance Program, you and your patient will need to complete the Patient Assistance Program Enrollment Form.

Patient qualifications

Patient enrollment instructions

Patients must meet all the requirements listed below to qualify:

  • Have been prescribed MARGENZA for a medically appropriate use
  • Are a permanent, legal resident of the United States, Puerto Rico, or US Virgin Islands
  • Have no insurance or their insurance does not cover MARGENZA (except for Medicare beneficiaries, subject to certain restrictions)
  • The treatment must be provided in an outpatient setting
  • Must have received treatment within 180 days of application approval
  • Your Annual Household Income must meet the current established threshold
How to enroll

Important - the entire application must be completed

Patient instructions:

  • Have the patient complete the Patient section on page 2 and include appropriate documentation about his or her household income
  • Have the patient sign the Patient Agreement and Consent on page 2
  • Have the patient sign the HIPAA Authorization on page 4

Prescriber instructions:

  • Complete the Prescriber section on pages 5 and 6
  • The prescriber must manually sign the Prescriber Information on page 5 and the Prescriber Acknowledgment on page 6. Rubber stamps, signature by other office personnel for the prescriber, and computer-generated signatures will not be accepted

Submit the application

  • Fax the completed application and any supporting documents to MARGENZA Access Support at 1-844-256-5226
  • Please make sure all information is provided correctly and signatures are obtained; incomplete or incorrect information will delay the process

Download Form

When complete, fax form to 1-844-256-5226.

Independent Foundations

Please call MARGENZA Access Support and we can provide a list of independent/third party foundations that provide funding for cancer patients with financial hardships. These independent foundations and charities can provide various forms of assistance to patients who qualify under their rules.

Although we cannot provide information about a foundation’s funding availability, enrollment process or eligibility guidelines, this information is available from each organization.

The list of independent organizations is not owned or controlled by MacroGenics, which makes no representations about the services and information they may offer. Their inclusion on this website is not intended as an endorsement of the organizations or the services offered, nor are they an indication of the organizations’ endorsement of MARGENZA.

Questions?

1-844-MED-MGNX
(1-844-633-6469)

MARGENZA Access Support is available
Monday-Friday 9AM to 7PM ET

IMPORTANT SAFETY INFORMATION

WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

  • Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
  • Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.
WARNINGS & PRECAUTIONS:
Left Ventricular Dysfunction
  • Left ventricular cardiac dysfunction can occur with MARGENZA.
  • In SOPHIA, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
  • MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
  • Withhold MARGENZA for ≥16% absolute decrease in LVEF from pretreatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
  • Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
  • Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
  • Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.
Embryo-Fetal Toxicity
  • Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
  • Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
  • Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
  • Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.
Infusion-Related Reactions (IRRs)
  • MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
  • In SOPHIA, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.
  • Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
  • In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
  • Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.
MOST COMMON ADVERSE REACTIONS:

The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

INDICATION

MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Please see full Prescribing Information, including Boxed Warning.