Limited coverage drugs – raloxifene

Generic name / strength / form

raloxifene - all strengths and forms
Criteria Approval period

Clinical or radiographically documented fracture due to osteoporosis

AND

  1. demonstrated intolerable side effects to a minimum 1 month trial of oral bisphosphonates, alendronate or risedronate

OR

  1. unsatisfactory clinical response, defined as a new fragility fracture after 1-year adherence to alendronate or alendronate plus cholecalciferol or risedronate therapy

Indefinite

Practitioner exemptions

  • No practitioner exemptions

Special notes

Definitions for the above criteria:

  • Clinical fracture: a symptomatic (painful) fracture
  • Radiographically documented fracture: a fracture identified by x-ray (e.g., vertebral compression fracture) and may be asymptomatic
  • Intolerable side effects: esophageal ulceration, erosion or stricture, or lower gastrointestinal symptoms severe enough to cause discontinuation of bisphosphonates
  • Fragility fracture: a fracture that occurs as a result of minimal trauma (e.g., a fall from a standing height or less)

Special Authority requests