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