Limited coverage criteria – raloxifene

 

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Generic name		raloxifene
Strength & form		all strengths and forms

Special Authority criteria	Approval period
Clinical1 or radiographically2 documented fracture due to osteoporosis AND Demonstrated intolerable side effects3 to a minimum 1 month trial of oral bisphosphonates, alendronate or risedronate OR   Unsatisfactory clinical response, defined as a new fragility fracture4 after 1-year adherence to alendronate or alendronate plus cholecalciferol or risedronate therapy	Indefinite

Practitioner exemptions

• None

Special notes

• ¹Clinical fracture is defined as a symptomatic (painful) fracture
• ²Radiographically documented fracture is defined as a fracture identified by x-ray (e.g., vertebral compression fracture) and may be asymptomatic
• ³Intolerable side effects are defined as esophageal ulceration, erosion or stricture, or lower gastrointestinal symptoms severe enough to cause discontinuation of bisphosphonates
• ⁴Fragility fracture is a fracture that occurs as a result of minimal trauma (e.g., a fall from a standing height or less)

Special Authority request form(s)

• Log in to eForms​
• HLTH 5328 – General Special Authority request (PDF, 656KB)