Pharmacy Prior Authorization Criteria

Viltepso (viltolarsen) - PA, NF

Indications for Prior Authorization

Viltepso (viltolarsen)

• 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 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with Viltepso. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Criteria

Viltepso

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Both of the following:
• Diagnosis of Duchenne muscular dystrophy (DMD)
AND
• Confirmed mutation of the dystrophin gene amenable to exon 53 skipping
AND
• Patient is 4 years of age or older
AND
• Prescribed by or in consultation with a neurologist with expertise in the treatment of DMD
AND
• Dose will not exceed 80 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) [2, 3]

Viltepso

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient is tolerating therapy
AND
• Dose will not exceed 80 milligrams per kilogram of body weight infused once weekly
AND
• Prescribed by or in consultation with a neurologist with expertise in the treatment of DMD
AND
• Patient is maintaining ambulatory status without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair)

Viltepso

Non Formulary

Length of Approval: 6 Month(s)

• Submission of medical records (e.g., chart notes, laboratory values) documenting both of the following:
• Diagnosis of Duchenne muscular dystrophy (DMD)
AND
• Confirmed mutation of the dystrophin gene amenable to exon 53 skipping
AND
• Patient is 4 years of age or older
AND
• Prescribed by or in consultation with a neurologist with expertise in the treatment of DMD
AND
• Dose will not exceed 80 milligrams per kilogram of body weight infused once weekly
AND
• Submission of medical records (e.g., chart notes, laboratory values) documenting the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair) [2, 3]

P & T Revisions

2024-10-18, 2023-10-04, 2022-10-05, 2022-06-06, 2021-12-16, 2021-10-06, 2021-06-02, 2020-10-07

References

1. Viltepso Prescribing Information. NS Pharma, Inc. Paramus, NJ. January 2023.
2. ClinicalTrials.gov. Safety and Dose Finding Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD). NCT02740972. Website. Available at: https://clinicaltrials.gov/ct2/show/NCT02740972?term=NCT02740972&draw=2&rank=1. Accessed September 19, 2024.
3. Per Clinical Consultation with a Pediatrician, April 25, 2019 and January 22, 2020.

---

Revision History

• 2024-10-18: Annual review: updated prescriber requirement and background.
• 2023-10-04: Annual review: Updated criteria and background.
• 2022-10-05: Annual review: Background updates.
• 2022-06-06: Update Guideline
• 2021-12-16: Addition of NF criteria
• 2021-10-06: Annual review: Background updates.
• 2021-06-02: Updated reauthorization criteria.
• 2020-10-07: New program

---