Limited coverage criteria – rozanolixizumab

Generic name

rozanolixizumab

Strength & form

140 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

• Patient has a positive serologic test for either anti-acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibodies

AND

• Patient has not had a thymectomy within 6 months

AND

• Patient has a Myasthenia Gravis Activities of Daily Living (MG-ADL) score at baseline of 3 or greater (with at least 3 points coming from non-ocular symptoms)

AND

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

AND

• Patient must have symptoms that persist despite undergoing a trial of treatment(s) appropriate to their antibody status as detailed below:

a. MuSK antibody postive:

• The patient has undergone a trial of optimally dosed rituximab, resulting in at least one exacerbation or myasthenic crisis, within the previous 12 months

OR

• The patient cannot tolerate or has a contraindication to rituximab, leading to discontinuation or inability to use rituximab, and the patient has not achieved adequate symptom control despite receiving at least 1 cumulative year of treatment, either in combination or as a monotherapy, with 2 or more of the following therapies: azathioprine, mycophenolate, cyclosporine, cyclophosphamide, methotrexate, tacrolimus, corticosteroids for gMG, or other immunosuppressive therapies (ISTs)

b. AChR antibody positive:

• 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)

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 rozanolixizumab treatment, documented as:

• On initial renewal after 6 months of treatment with rozanolixizumab, patient must demonstrate an improvement of at least 2 points in the 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 rozanolixizumab therapy