ACCESS

Learn more about access and co-pay support for VYVGART and VYVGART Hytrulo

Patient portrayal

Broad access for your patients

~85%

of US commercial and Medicare patients have a published VYVGART policy for IV infusions1*

VYVGART Hytrulo policies are anticipated to be aligned to VYVGART policies upon the standard formulary review process.

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

*Policy reporter data as of September 2022.
 IV=intravenous.

>90%

of US commercial and Medicare published policies provide an initial authorization of ≥6 months1

This can allow for multiple infusion cycles with the first prescription†

†Policy reporter data as of April 2023.

Find local payer coverage policies for your patients

argenx has a network of national distributors, specialty pharmacies, and infusion partners, making it easier for appropriate patients to access VYVGART or VYVGART Hytrulo

Help your patients save on their treatment with VYVGART or VYVGART Hytrulo

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

Learn more

Not actual size.

Billing and coding insights

When submitting reimbursement for VYVGART, use HCPCS J-Code J9332 (injection, efgartigimod alfa-fcab, 2 mg).

  • Download VYVGART Billing and Coding Guide

When submitting reimbursement for VYVGART Hytrulo, use HCPCS J-Code J9334 (injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc).

  • Do not use J9332 for VYVGART Hytrulo
  • Download VYVGART Hytrulo Billing and Coding Guide

HCPCS=Healthcare Common Procedure Coding System.

Get direct support for your practice

Field Reimbursement Managers are available to educate your practice about acquiring VYVGART or VYVGART Hytrulo, including insurance approvals, reimbursement, and co-pay assistance.

Contact a Field Reimbursement Manager at 1-833-697-2841 for assistance for your patients.

Access support for you and your practice

KEY

  • VYVGART
  • VYVGART Hytrulo
  • VYVGART & VYVGART Hytrulo

VYVGART Savings Program HCP Brochure

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

VYVGART Hytrulo Acquisition Guide

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

VYVGART Acquisition Guide

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

VYVGART Hytrulo Letter of Medical Necessity

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

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. 

VYVGART Hytrulo Billing & Coding Guide

A guide to help your office submit claims for VYVGART Hytrulo with an assigned J-Code: J9334.

VYVGART Billing and Coding Guide

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

VYVGART Hytrulo Prior Authorization Checklist

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

VYVGART Prior Authorization Checklist

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

VYVGART Hytrulo Letter of Claims Appeal

This document provides guidance for appealing a denied or underpaid VYVGART Hytrulo claim.

VYVGART Letter of Claims Appeal

This document provides guidance for appealing a denied or underpaid VYVGART claim.

VYVGART and VYVGART Hytrulo Insurance Primer

A guide to provide you additional nonclinical information that may impact your decision to prescribe a patient VYVGART or VYVGART Hytrulo.

Field Reimbursement Manager Guide

A resource for you to learn more about Field Reimbursement Managers and how they can help your office.

VYVGART and VYVGART Hytrulo Prior Authorization Worksheet

A quick reference checklist to help you and office staff identify the common prior authorization requirements for VYVGART and VYVGART Hytrulo.

Receive more information about VYVGART, VYVGART Hytrulo, and anti-AChR antibody positive gMG

 

Contact a rep

 

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis.

CONTRAINDICATIONS

VYVGART and VYVGART HYTRULO are contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART or VYVGART HYTRULO, respectively. VYVGART HYTRULO is also contraindicated in patients with serious hypersensitivity to hyaluronidase. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab 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 the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

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

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor patients during and for 1 hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs during administration, discontinue VYVGART infusion and initiate appropriate therapy. If a severe infusion-related reaction occurs with VYVGART HYTRULO, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART or VYVGART HYTRULO following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medications.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART and VYVGART HYTRULO are 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 or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, 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 or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each 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 for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

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).

CONTRAINDICATIONS

VYVGART and VYVGART HYTRULO are contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART or VYVGART HYTRULO, respectively. VYVGART HYTRULO is also contraindicated in patients with serious hypersensitivity to hyaluronidase. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab 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 the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

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

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor patients during and for 1 hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs during administration, discontinue VYVGART infusion and initiate appropriate therapy. If a severe infusion-related reaction occurs with VYVGART HYTRULO, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART or VYVGART HYTRULO following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medications.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART and VYVGART HYTRULO are 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 or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, 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 or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each 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 for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

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. January 2024.