ENROLL PATIENTS

Enroll your patients and get them started on VYVGART

Two ways to enroll your patients in My VYVGART® Path

Online Enrollment

Fill out and submit the My VYVGART Path enrollment form online at MyPathEnroll.com

Enrollment via Fax

Download the enrollment form and fax the completed document to 1-833-698-7284

Key details about the enrollment process for VYVGART

HCPCS=Healthcare Common Procedure Coding System.

Patient portrayal

Broad access for your patients

~85%

of US commercial and Medicare patients have a published VYVGART policy1*


  • Medicare Part B covers medications for indications, which are FDA approved to label
  • As with all commercial insurance plans, coverage for VYVGART will depend on the terms and conditions of your patient’s insurance plan

*Policy reporter data as of September 2022.

Help your patients save on their treatment with VYVGART

Your patients could be eligible to pay as little as $0 for their co-pay through the VYVGART Co-pay Program.*


What should I tell my patients?

  • The VYVGART Co-pay Program is for patients with commercial insurance and a valid prescription for VYVGART for an on-label indication
  • VYVGART must be covered by patients' commercial insurance
  • Patients may be reimbursed for eligible out-of-pocket costs for VYVGART and related administration costs, up to $25,000 savings per calendar year*
  • If you have enrolled your patient in My VYVGART Path, a Nurse Case Manager can enroll them in the VYVGART Co-pay Program and answer their questions
  • Patients can also be enrolled through their specialty pharmacist when they fill their prescription

*Eligible commercially insured patients may pay as little as $0 for VYVGART and may receive a maximum benefit of $25,000 per calendar year for their eligible out-of-pocket costs for the drug and drug administration. Persons residing in MA and RI are not eligible for financial assistance related to administration costs. Please see full Terms and Conditions.

What if my patient does not have commercial or private insurance?

If you've enrolled them in My VYVGART Path, you can direct them to a Nurse Case Manager, who will help them understand potential financial assistance programs.

Access support for you and your practice

Enrollment Form

Downloadable version of VYVGART enrollment form to fill out and fax to get patients started on VYVGART and enrolled in My VYVGART Path.

HCP PSP Overview Brochure

An overview of support offerings for you and your patients through the My VYVGART Path program.

VYVGART Savings Program HCP Brochure

An overview of the co-pay assistance program available to eligible patients with commercial insurance.

VYVGART Acquisition Guide

A guide to help your office staff work with specialty distributors and specialty pharmacies to get VYVGART for your patients.

Billing and Coding Guide

A guide to help your office submit claims for VYVGART with an assigned J-Code: J9332.

VYVGART Prior Authorization Checklist

A checklist for you and office staff regarding common prior authorization requirements for VYVGART. 

VYVGART Letter of Medical Necessity

A sample letter of medical necessity explaining why you have prescribed VYVGART with patient-specific information that health plans can use to assess your request. 

Spanish Enrollment Form

Downloadable Spanish-language version of the VYVGART enrollment form to fill out and fax to get patients started on VYVGART and enrolled in My VYVGART Path.

Infection

VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% for VYVGART vs 5% for placebo) and respiratory tract infection (33% for VYVGART vs 29% for placebo). Patients on VYVGART vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART administration in patients with an active infection until the infection is resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART until the infection has resolved.

Immunization

Immunization with vaccines during VYVGART treatment has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART causes a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during VYVGART treatment. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART.

Hypersensitivity Reactions

Hypersensitivity reactions, including rash, angioedema, and dyspnea, were observed with VYVGART. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, discontinue VYVGART infusion and institute appropriate supportive measures if needed.

ADVERSE REACTIONS

The most common (≥10%) adverse reactions with VYVGART were respiratory tract infection, headache, and urinary tract infection.

USE IN SPECIFIC POPULATIONS

Pregnancy

As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART in utero.

Lactation

There is no information regarding the presence of VYVGART in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART and any potential adverse effects on the breastfed infant from VYVGART or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

Infection

VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% for VYVGART vs 5% for placebo) and respiratory tract infection (33% for VYVGART vs 29% for placebo). Patients on VYVGART vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART administration in patients with an active infection until the infection is resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART until the infection has resolved.

Immunization

Immunization with vaccines during VYVGART treatment has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART causes a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during VYVGART treatment. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART.

Hypersensitivity Reactions

Hypersensitivity reactions, including rash, angioedema, and dyspnea, were observed with VYVGART. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, discontinue VYVGART infusion and institute appropriate supportive measures if needed.

ADVERSE REACTIONS

The most common (≥10%) adverse reactions with VYVGART were respiratory tract infection, headache, and urinary tract infection.

USE IN SPECIFIC POPULATIONS

Pregnancy

As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART in utero.

Lactation

There is no information regarding the presence of VYVGART in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART and any potential adverse effects on the breastfed infant from VYVGART or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

Reference: 1. Data on file, argenx US Inc. December 2022.