Eteplirsen (Exondys 51)

OFFICE ADMINISTRATION [medical benefit]

Indications for Prior Authorization:

  • Duchene muscular dystrophy (DMD)

Patients must meet the following criteria for the indication(s) above:

  • Prescribed by or in consultation with a physician who specializes in treatment of DMD

  • Confirmed mutation of the DMD gene amenable to exon 51 skipping (lab results from genetic testing are required); AND
  • Must be initiated in childhood (before 14 years of age); AND
  • Member is able to achieve an average distance of at least 180 m while walking independently over 6 minutes
  • For continuation of use: members must have demonstrated a response to therapy as evidenced by remaining ambulatory (e.g able to walk with or without assistance, not wheelchair dependent)

The following conditions do not meet the criteria for use as established by WHA P&T committee:

  • All non-FDA approved uses not listed in the approved indications

Dosing:

  • 30mg/kg body weight IV once weekly

Approval:

  • 1 year

Last review date: March 22, 2017