Pharmacy Prior Authorization Criteria

Amondys 45 (casimersen) - PA, NF

Indications for Prior Authorization

Amondys 45 (casimersen)

• For diagnosis of Duchenne muscular dystrophy (DMD)
  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.

Criteria

Amondys 45

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of Duchenne muscular dystrophy (DMD)
AND
• Patient has a mutation of the dystrophin gene amenable to exon 45 skipping
AND
• Patient is 7 years of age or older
AND
• Prescribed by or in consultation with a neurologist who has experience treating children
AND
• Dose will not exceed 30 milligrams per kilogram of body weight infused once weekly
AND
• Patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)

Amondys 45

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient is tolerating therapy
AND
• Prescribed by or in consultation with a neurologist who has experience treating children
AND
• Dose will not exceed 30 milligrams per kilogram of body weight infused once weekly
AND
• Patient is maintaining ambulatory status without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)

Amondys 45

Non Formulary

Length of Approval: 6 Month(s)

• Submission of medical records (e.g., chart notes, laboratory values) confirming both of the following:
• Diagnosis of Duchenne muscular dystrophy (DMD)
AND
• Patient has a mutation of the dystrophin gene amenable to exon 45 skipping
AND
• Patient is 7 years of age or older
AND
• Prescribed by or in consultation with a neurologist who has experience treating children
AND
• Dose will not exceed 30 milligrams per kilogram of body weight infused once weekly
AND
• Submission of medical records (e.g., chart notes, laboratory values) confirming the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)

P & T Revisions

2024-05-03, 2023-12-11, 2023-10-25, 2023-05-04, 2022-06-02, 2022-05-05, 2021-12-16, 2021-05-28

References

1. Amondys 45 Prescribing Information. Sarepta Therapeutics, Inc. Cambridge, MA. March 2023..

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Revision History

• 2024-05-03: Annual review: Updated criteria and background.
• 2023-12-11: Update to reauth language.
• 2023-10-25: Program Update
• 2023-05-04: Annual review: Background and formatting updates.
• 2022-06-02: Removed submission of medical records and/or paid claims requirement from prior authorization criteria.
• 2022-05-05: Annual review: No updates required.
• 2021-12-16: Addition of Non-form criteria
• 2021-05-28: New program

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