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

 

Last review date: June 10, 2019

Rite Aid Pharmacy Patients: All Rite Aid pharmacies nationwide are closing! Please be on the lookout for information from Rite Aid pharmacies about their bankruptcy and store closures. Call your Rite Aid pharmacy for questions about your prescriptions and new pharmacy options. WHA is here to help as well. Contact Us via Phone