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.

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® or Ultomiris®;

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

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.

Addendum:

1)    Effective 10-01-2022: Updated to reflect not prescribed concurrently with Ultomiris for Generalized Myasthenia Gravis.