WHA

EVENITY (romosozumab-aqqg)


OFFICE ADMINISTRATION - INJECTION


Indications for Prior Authorization:
  • Treatment of osteoporosis in postmenopausal women
    • At high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, OR
    • Patients who have failed or are intolerant to other available osteoporosis therapy
Patients must meet the following criteria for the indications(s) above:
  • Patient is a postmenopausal female
  • One of the following (1, 2, or 3):
    • 1) T-score less than or equal to -2.5SD, OR
    • 2) Evidence of osteoporotic fracture or a fragility fracture, OR
    • 3) Low bone mass and the physician determines that the patient is at high risk for fracture as evident by chart notes, AND
  • One of the following (A, B, C, D, or E):
    • A)Patient had an inadequate response, as evidenced by documented worsening BMD, following at least one year of therapy with a bisphosphonate AND an additional year of treatment with Prolia, OR
    • B)Patient had a non-traumatic fracture while on bisphosphonate therapy or Prolia, OR
    • C)Patient had an intolerable side effect or contraindication to both oral and IV bisphosphonate therapy AND an intolerable side effect or contraindication to Prolia, OR
    • D)Patient has tried ibandronate injection or zoledronic acid injection, OR
    • E)Patient has severe renal impairment or chronic kidney disease, AND
  • Patient has received no more than 12 monthly doses during this therapy course, AND
  • Patient does not have hypocalcemia, AND
  • Patient did not have a myocardial infarction or stroke within the preceding year
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
  • Combination therapy with a bisphosphonate, Prolia, Forteo, Tymlos, Evista or calcitonin
Dosing:
  • Recommended dose is 210 mg (2 syringes) administered subcutaneously once every month for a duration of 12 months.
Approval:
  • Initial approval: 12 months
  • Renewal: None
     

Last review date: July 16, 2019