Agamree (vamorolone oral suspension – Santhera/Catalyst) — Cigna

Duchenne Muscular Dystrophy

Initial criteria

Patient is age ≥ 2 years; AND
Patient’s diagnosis of Duchenne Muscular Dystrophy is confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene [documentation required]; AND
Patient meets ONE of the following (a or b):
a) Patient has tried prednisone or prednisolone for ≥ 6 months [documentation required] AND according to the prescriber, the patient has had at least ONE of the following significant intolerable adverse effects [1, 2, 3, or 4]:
1) Cushingoid appearance [documentation required]; OR
2) Central (truncal) obesity [documentation required]; OR
3) Undesirable weight gain defined as ≥ 10% body weight increase over a 6‑month period [documentation required]; OR
4) Diabetes and/or hypertension that is difficult to manage according to the prescriber [documentation required]; OR
b) According to the prescriber, the patient has experienced a severe behavioral adverse event while on prednisone or prednisolone therapy that has or would require a prednisone or prednisolone dose reduction [documentation required]; AND
The medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders.

Patient is age ≥ 2 years; AND
Patient has tried prednisone or prednisolone [documentation required]; AND
According to the prescriber, the patient has responded to or continues to have improvement or benefit from Agamree therapy [documentation required]; AND
The medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders.
Note: Examples of improvement or benefit from Agamree therapy include improvements in motor function (e.g., time from supine to standing, time to climb four stairs, time to run or walk 10 meters, 6‑minute walk test), improvement in muscle strength, and improved pulmonary function.

1 year