Limited coverage criteria – zilucoplan

Generic name

zilucoplan

Strength & form

40 mg/mL solution for subcutaneous injection

Initial

For the treatment of refractory generalized myasthenia gravis (gMG) in adult patients when ALL of the following criteria are met:

• Special Authority is requested by a neurologist with expertise in the diagnosis and management of gMG

AND

• Patients has a positive serologic test for anti-acetylcholine receptor (AChR) antibodies

AND

• Patient has not had a thymectomy within 12 months

AND

• Patient has a Myasthenia Gravis Activities of Daily Living (MG-ADL) score at baseline of 6 or greater

AND

• Patient has a Myasthenia Gravis Foundation of America (MGFA) class II to IV disease

AND

• Patient must have symptoms that persist after 1 of the following:

a. Patient has undergone at least 1 cumulative year of treatment, either in combination or as a monotherapy, using 2 or more of the following therapies: azathioprine, mycophenolate, cyclosporine, cyclophosphamide, methotrexate, tacrolimus, corticosteroids for gMG, or other immunosuppressant therapies (IST)

OR

b. Patient has a history of treatment with at least 1 IST for a total duration of 1 year or more and has received chronic plasma exchange, intravenous immunoglobulin, or subcutaneous immunoglobulin at least every 3 months for a 12-month period

6 months

Renewal

To be eligible for renewal of coverage, Special Authority must be requested by a neurologist with expertise in the diagnosis and management of gMG, and the patient must demonstrate clinical benefit from zilucoplan treatment, documented as:

• On initial renewal after 6 months of treatment with zilucoplan, patient must demonstrate an improvement of at least 2 points or greater in MG-ADL score

OR

• On subsequent renewals after the first, patient must have maintained the improved MG-ADL score that was achieved after the first 6 months of zilucoplan therapy