Prolia (Preservative Free)

Only for a patient who is established on Prolia (denosumab) therapy prior to November 29, 2024 and who is or becomes palliative requiring end-of-life care during the biosimilar transition period between November 29, 2024 to August 29, 2025.

Patient must also meet the following criteria:

- The patient is a postmenopausal female or male with osteoporosis and Prolia (denosumab) is being used to increase the bone mass in the patient;

- The patient is at high risk* for fracture; and

- One of the following applies to the patient:

- The patient has failed other available osteoporosis therapy (i.e., fragility fracture or evidence of a decline in bone mineral density below pre-treatment baseline levels) despite adherence to the therapy for one year;

or

- bisphosphonates are contraindicated for the patient due to hypersensitivity, abnormalities of the esophagus (e.g., esophageal stricture or achalasia), or inability to stand or sit upright for at least 30 minutes.

*High risk of fracture is defined as one of the following:

- a prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool;

- a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; or

- where a patient's 10-year fracture risk based on the CAROC or FRAX tool is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture.

Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors.

Funded duration: One period of up to 12 months beginning on the date of the first prescription with RFU code 690 is dispensed for the patient.