Denosumab (Prolia)

Approved for: 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:

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
Failed on a bisphosphonate following at least one year of therapy, or had a non-traumatic fracture while on a bisphosphonate

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.

The drug is not covered for:

combination therapy with other agents for osteoporosis

any indication not listed in this policy


Western Health Advantage Pharmacy and Therapeutics Committee

Approved/Revised: September 2014                                         Reviewed: