Denosumab (Prolia)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • Post Menopausal Osteoporosis
  • Osteopenia in breast cancer, secondary to hormone ablation therapy
  • To increase bone mass in men with osteoporosis

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee.

  • Padgett's disease
  • prevention of Osteoporosis
  • any other diagnosis not listed in the approved indications

Treatment of postmenopausal osteoporosis in women OR to increase bone mass in men with osteoporosis

  • Evidence of a non-traumatic fracture, OR
  • T-scores less than -2.5 SD AND
  • Meets the criteria in either A, B or C:
    • A)
      • Unable to take an oral bisphosphonate due to one of the following reasons:
        • 1) Patient has an intrinsic swallowing mechanism defect, OR
        • 2) Patient is unable to sit upright for 30 minutes, OR
        • 3) Patient has currently active pre-existing conditions: esophagitis, Barrett's esophagus, active gastric ulcer, active gastritis, GERD managed with a PPI, symptomatic hiatal hernia, or gastric bypass
      • AND, One of the following:
        • Intolerance to prior IV bisphosphonate therapy and request for denosumab is for no sooner than next scheduled dose of IV bisphosphonate, OR
        • Contraindication to IV bisphosphonates, OR
    • B) Patient has had intolerable gastric side effects to a monthly oral bisphosphonate regimen that would cause him/her to discontinue therapy, OR
    • C) Inadequate response to bisphosphonate therapy as evidenced by one of the following:
      • Documented worsening BMD on a bisphosphonate following at least one year of therapy, OR
      • Had a non-tramatic fracture while on a bisphosphonate
    • Covered dose: up to 60mg SC administered once every 6 months

Increase BMD in patients with hormone-response breast cacner undergoing hormone ablation therapy

  • Patient is currently taking an aromatase inhibitor, tamoxifen, or GNRH agonist, AND
  • Meets the criteria in either a, b, c or d:
    • a) Patient is unable to take an oral bisphosphonate (see bullet A in osteoporosis criteria), AND has intolerance or conraindication to an IV bisphosphonate, OR
    • b) Patient has had an inadequate respone to bisphosphonate therapy as evidenced by a documented worsening BMD while on a bisphosphonate for at least one year, OR
    • c) Patient experienced a non-traumatic fracture while on a bisphosphonate, OR
    • d) Patient has had intolerable gastric side effects to a monthly oral bisphosphonate regimen that would cause him/her to discontinue therapy.
  • Covered Dose: up to 60mg SC administered once every 6 months

This medication is Not Approvable for the following condition(s):

  • combination therapy with other agents for osteoporosis
  • any indication not listed in this policy

 

Last review date: September 1, 2014

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