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)    Rystiggo (rozanolixizumab-noli) requires prior authorization.

2)    Rystiggo is indicated for the treatment of generalizedmyasthenia gravis (gMG) in adult patients.

3)    Rystiggo is covered under the medical benefit.

Initial Approval Criteria

I.             Generalized Myasthenia Gravis (must meet all):

a.    Diagnosis of gMG;

b.    Prescribed by or in consultation with a neurologist;

c.    Age > 18 years;

d.    Myasthenia Gravis Activities of Daily Living (MG-ADL) > 3 from non-ocular symptoms at baseline;

e.    Myasthenia Gravis Foundatoin of America (MGFA) clinical classification of Class II to Iva;

f.     Member has positive serologic test for one of the following:

                                          i.    Anti-AChR antibodies;

                                        ii.    Anti-MuSK antibodies;

g.    If member has positive serologic test for anti-AChR antibodies: Failure of a cholinesterase inhibitor unless contraindicated or clinically significant adverse effects are experienced;

h.    Failure of a corticosteroid unless contraindicated or clinically significant adverse effects are experienced;

i.      Failure of at least one immunosuppressive therapy unless clinically significant adverse effects are experienced or all are contraindicated;

j.      Rystiggo is not prescribed concurrently with Vivgart, Vivgart Hytrulo, Soliris, or Ultomiris;

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

l.      Dose is consistent with FDA labeling

Approval Duration: 6 months

Continued Therapy Criteria

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

2.    Rystiggo is not prescribed concurrently with Vivgart, Vivgart Hytrulo, Soliris, or Ultomiris;

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

4.    Dosing consistent with FDA labeling

Continued Therapy Approval Duration: 6 months

Codes Used In This BI:

J9333 – Injection, rozanolixizumab-noli, 1mg

1.    Rystiggo Prescribing Information. Smyrna, GA: UCB; June 2023. Available at: https://www.ucb-usa.com/RYSTIGGO-prescribing-information.pdf. Accessed July 10, 2023.

2.    Bril V, Drużdż A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-394.

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.