PROLIA (denosumab)

PROLIA (denosumab)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Postmenopausal 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 intolerance to prior oral and IV bisphosphonate therapy that would cause discontinuation, 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-traumatic fracture while on a bisphosphonate
  • Covered dose: up to 60mg SC administered once every 6 months

Increase BMD in patients with hormone-response breast cancer 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 contraindication to an IV bisphosphonate, OR
  • b) Patient has had an inadequate response 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