Limited coverage drugs – denosumab

 

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Biosimilar transition initiative

PharmaCare is changing coverage of denosumab for osteoporosis. To maintain PharmaCare coverage, patients currently covered for the originator demosumab biologic product, Prolia^®, must, in consultation with their prescriber, switch to the approved biosimilar product, Jubbonti^®.

Prescribers may request a list of their patients prescribed Prolia brand of denosumab, so they can contact them to start the switch to Jubbonti^®. 

• HLTH 5860 – Denosumab patient list request (PDF, 968KB)

August 29, 2024

All new Special Authority (SA) requests, including renewals, for denosumab will only be approved for Jubbonti.

August 29, 2024 to March 3, 2025

During the six-month transition period, patients with PharmaCare coverage for the originator denosumab (Prolia) who wish to maintain their coverage must transition to the biosimilar denosumab (Jubbonti). A new SA request is not required until the next scheduled renewal date (if applicable). To maintain patients' coverage, prescribers must write a new prescription for their patients on the originator denosumab (Prolia), indicating the transition to biosimilar denosumab (Jubbonti). 

March 4, 2025

The  originator denosumab (Prolia) is no longer an eligible PharmaCare benefit and only biosimilar denosumab (Jubbonti) is authorized for continued coverage. 

SA requests for patients who are unable to transition to biosimilar denosumab will be considered on an exceptional case-by-case basis. 

 

Generic name: denosumab
Strength & form	60 mg/ mL pre-filled syringe

Special Authority criteria	Approval period
For the treatment of women with postmenopausal osteoporosis or men with osteoporosis AND With clinical or radiographically documented fracture due to osteoporosis AND For whom oral bisphosphonates are contraindicated for one of the following reasons: Immune-mediated hypersensitivity reaction to oral bisphosphonates, or Abnormalities of the esophagus that delay esophageal emptying such as stricture or achalasia	Indefinite
For primary prevention of osteoporotic fractures in women with breast cancer who are receiving aromatase inhibitor therapy	5 years

Practitioner exemptions

• None

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, such as a vertebral compression fracture. This may be asymptomatic

Special Authority requests

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