Coverage Policies

Use the index below to search for coverage information on specific medical conditions.

High-Tech Imaging: High-Tech Imaging services are administered by National Imaging Associates, Inc. (NIA). For coverage information and authorizations, click here.

Medical Providers: Payment for care or services is based on eligibility, medical necessity and available benefits at time of service and is subject to all contractual exclusions and limitations, including pre-existing conditions if applicable.

Future eligibility cannot be guaranteed and should be rechecked at time of service. Verify benefits by signing into My Account or calling Customer Service at 800.235.7111 or 501.228.7111.

If not specified in a QualChoice coverage policy (Benefit Interpretation), QualChoice follows care guidelines published by MCG Health.

QualChoice reserves the right to alter, amend, change or supplement medical policies as needed. QualChoice reviews and authorizes services and substances. CPT and HCPCS codes are listed as a convenience and any absent, new or changed codes do not alter the intent of the policy.

INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 07/01/2022 Title: Vyvgart
Revision Date: Document: BI707:00
CPT Code(s): J9332
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Vyvgart (efgartigimod alfa) requires prior authorization.

2)    Vyvgart is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.


Medical Statement

Initial Approval Criteria A. Generalized Myasthenia Gravis (must meet all):

 

1. Diagnosis of gMG;

2. Prescribed by or in consultation with a neurologist;

3. Age ≥ 18 years;

4. Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥ 5 at baseline;

5. Greater than 50% of the baseline MG-ADL score is due to non-ocular symptoms;

6. Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IV;

7. Member has positive serologic test for anti-AChR antibodies;

8. Failure of a cholinesterase inhibitor (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced;

9. Failure of a corticosteroid (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced;

10. Failure of at least one immunosuppressive therapy (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated;

11. Vyvgart is not prescribed concurrently with Soliris®;

12. Documentation of member’s current weight (in kg);

13. Dose does not exceed 10 mg/kg (1,200 mg per infusion for members weighing 120 kg or more) once weekly for the first 4 weeks of every 8-week cycle.

Approval duration: 6 months

 

 

Continued Therapy

A. Generalized Myasthenia Gravis (must meet all):

1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;

2. Member is responding positively to therapy as evidenced by a 2-point reduction in MG-ADL total score;

3. Documentation of member’s current weight (in kg);

4. If request is for a dose increase, new dose does not exceed 10 mg/kg (1,200 mg per infusion for members weighing 120 kg or more) once weekly for the first 4 weeks of every 8-week cycle.

Approval duration: 6 months

 

Codes Used In This BI:

 

1)    J9332 – Injection, efgartigimod alfa-fcab, 2mg


Reference

1. Vyvgart Prescribing Information. Boston, MA: argenx US, Inc.; December 2021. Available at: https://argenx.com/product/vyvgart-prescribing-information.pdf. Accessed January 4, 2022.

2. Howard JF, Bril V, Vu T, et al. Safety, efficacy, and tolerability of efgartigimod in patients with generalized myasthenia gravis (ADAPT): a multicenter, randomised, placebo-controlled, phase 3 trial. Lancet Neurology July 2021;20(7):526-36.

3. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology 2016;87:419-425.

4. Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis 2020 update. Neurology 2021;96:114-22.

5. Muppidi S, Silvestri N, Tan R, et al. The evolution of Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale utilization to measure myasthenia gravis symptoms and treatment response (1817). Neurology Apr 2021;96(15 Suppl):1817.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.