Agamree (vamorolone) — Medica

Duchenne Muscular Dystrophy

Initial criteria

Patient is age ≥ 2 years
Diagnosis of Duchenne Muscular Dystrophy confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene [documentation required]
Patient meets ONE of the following:
- Patient has tried prednisone or prednisolone for ≥ 6 months [documentation required] AND has had ≥ 1 intolerable adverse effect (Cushingoid appearance OR central/truncal obesity OR undesirable weight gain ≥10% over 6 months OR diabetes and/or hypertension that is difficult to manage) [documentation required]
- OR patient has experienced a severe behavioral adverse event while on prednisone or prednisolone therapy that has or would require a prednisone/prednisolone dose reduction [documentation required]
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
Patient has tried prednisone or prednisolone [documentation required]
According to the prescriber, the patient has responded to or continues to have improvement or benefit from Agamree therapy [documentation required]
Examples of improvement or benefit include improvements in motor function, muscle strength, or pulmonary function
Medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders

1 year