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Limited coverage criteria – romosozumab

Last updated on March 26, 2025

 

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Generic name

romosozumab

Strength & form

105 mg/1.17 mL pre-filled syringe

Special Authority criteria

Approval period

For the treatment of osteoporosis in postmenopausal women who:

  • Have sustained an osteoporotic fracture

    AND
     
  • Are at high risk for future fracture, defined as 10-year fracture-risk ≥ 20% as defined by the Fracture Risk Assessment (FRAX) tool

    AND
     
  • Are treatment naive to osteoporosis medications, except for calcium and/or vitamin D

    AND
     
  • Will not be prescribed other osteoporosis medications concurrently with romosozumab, except for calcium and/or vitamin D

Up to 12 months1

Practitioner exemptions

  • None

Special notes

  • The maximum duration of coverage is 12 months. Coverage for retreatment with romosozumab will not be provided
  • If patient has had any romosozumab therapy prior to being approved for coverage by PharmaCare, it is expected that the total duration of therapy does not exceed 12 months
  • PharmaCare covers a maximum of 30 days of romosozumab per fill
  • PharmaCare coverage is limited to 210 mg of romosozumab monthly

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