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    Amondys 45

    Drug - Amondys 45 (casimersen) [Sarepta Therapeutics, Inc.]

    February 2022

    Therapeutic Area - Duchenne muscular dystrophy (DMD)

    Initial approval criteria

    • Patients have a diagnosis of Duchenne muscular dystrophy (DMD) AND
    • Patient must have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping AND
    • Patient serum cystatin C, urine dipstick, and urine protein-tocreatinine ratio (UPCR) are measured prior to starting therapy and periodically during treatment AND
    • Patient is not receiving concomitant therapy with other DMD-directed antisense oligonucleotides (e.g., eteplirsen, golodirsen, viltolarsen) AND
    • Patient has been on a stable dose of corticosteroids, unless contraindicated or intolerance, for at least 6 months AND
    • Patient retains meaningful voluntary motor function (e.g., patient is able to speak, manipulate objects using upper extremities, ambulate) AND
    • Patient should be receiving physical and/or occupational therapy AND
    • There is baseline documentation of ≥ 1 of the following:
      • 6-minute walk test (6MWT) or other timed function tests (e.g., time to stand [TTSTAND], time to run/walk 10 meters [TTRW], time to climb 4 stairs [TTCLIMB]) OR
      • Upper limb function (ULM) test OR
      • North Star Ambulatory Assessment (NSAA) OR
      • Forced Vital Capacity (FVC) percent predicted
    • Initial approval is for 6 months

    Renewal criteria

    • Patient continues to meet the above criteria AND
    • Patient has not experienced any treatment-restricting adverse effects (e.g., severe hypersensitivity reactions, renal toxicity/proteinuria) AND
    • Patient has responded to therapy compared to pretreatment baseline ≥ 1 of the following measures (not all-inclusive):
      • Stability, improvement, or slowed rate of decline in 6MWT or other timed function tests (e.g., time to stand [TTSTAND], time to run/walk 10 meters [TTRW], time to climb 4 stairs [TTCLIMB]) OR
      • Stability, improvement, or slowed rate of decline in ULM test OR
      • Stability, improvement, or slowed rate of decline in NSAA OR
      • Stability, improvement, or slowed rate of decline in FVC percent predicted OR
      • Improvement in quality of life based on prescriber attestation
    • Renewal approval is for 6 months

    Quantity limits

    • 30 mg/kg once weekly
    • Patient’s body weight (in kg) must be submitted at time of request

    Billing for Amondys 45

    Amondys 45 must be billed as a medical claim.

    Background

    Amondys 45 is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with Amondys 45. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials

    Questions?

    MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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