Denosumab (Prolia)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • Post Menopausal Osteoporosis
  • Bone metastasis in breast cancer and multiple myeloma
  • Osteopenia in breast cancer, secondary to hormone ablation therapy
  • To increase bone mass in men with osteoporosis
  • Osteopenia in prostate cancer, secondary to androgen deprivation therapy

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

All of the following must be met as a condition of coverage:

Post-Menopausal Osteoporosis or to Increase Bone Mass in Men with Osteoporosis

  • Treatment of osteoporosis in postmenopausal woman
  • T-score is more than -2.5 SD below the young normal or the presence or history of osteoporotic fracture AND
  • Intolerable side effects with two of the following oral bisphosphanates: Fosamax or Actonel and Boniva OR
  • For patients with intrinsic swallowing mechanism defect who cannot take any oral medication AND
  • Patient is not hypocalcemic AND
  • Intolerant to zoledronic acid yearly AND
  • Must be prescribed by a rheumatologist or endocrinologist or for patients with breast cancer, an oncologist

Osteopenia in breast cancer

  • Must be prescribed by an oncologist
  • Patient is currently taking an aromatase inhibitor, tamoxifen, or GNRH agonist AND
  • ONE of the following:
    • Patient is unable to take oral AND has intolerance or contraindication to an IV bisphosphonate OR
    • Failed on a bisphosphonate as evidenced by a documented worsening BMD on a bisphosphonate following at least one year of therapy, or had a non-traumatic fracture while on a bisphosphonate

Osteopenia in prostate cancer

  • Patient is currently taking androgen deprivation therapy [e.g. gonadotropin-releasing hormone GnRH agonists such as leuprolide(Lupron)] or has had surgical castration AND
  • ONE of the following:
    • Patient is unable to take oral bisphosphonate AND has intolerance or contraindication to an IV bisphosphonate OR
    • Failed on a bisphosphonate following at least one year of therapy, or had a non-traumatic fracture while on a bisphosphonate

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

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

Dosing:

  • The recommended dose is 60 mg every six months
  • All patients should receive one gram of calcium and 400 IU of vitamin D daily

 

Last review date: September 1, 2014