Limited Coverage Drugs - Denosumab

Generic Name

denosumab

Strength

60 mg
Form subcutaneous injection

Special Authority Criteria

Approval Period

For women with postmenopausal osteoporosis or men with osteoporosis

AND

with clinical or radiographically-documented fracture due to osteoporosis

AND

contraindication to oral bisphosphonates for one of the following reasons:

  • immune-mediated hypersensitivity reaction to oral bisphosphonates

OR

  • abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
Indefinite

Practitioner Exemptions

  • No practitioner exceptions.

Special Notes

  • The Special Authority Request must include details regarding a patient's contraindication to oral bisphosphonates.
  • Clinical fracture is defined as a symptomatic (painful) fracture.
  • Radiographically-documented fracture is defined as a fracture identified by X-ray (e.g., vertebral compression fracture). This may be asymptomatic.

Special Authority Request Form(s)