Product Details
Prolia (Preservative Free)
Denosumab60 mg/mL
Solution for Injection
Prefilled Syringe
DIN/PIN/NPN
02343541
Manufacturer
Amgen Canada Inc.
Formulary Listing Date
2012-02-29
Unit Price
440.1000
Amount MOH Pays
440.1000
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
M05BX04
Interchangeable Products
NOLU Clinical Criteria
| LU Code | Auth. Period | Clinical Criteria |
|---|---|---|
| Note: In all cases, patients receiving Prolia must not be receiving concomitant bisphosphonate therapy. The recommended dose of PROLIA (denosumab) is a single SC injection of 60 mg, once every 6 months. | ||
| 428 | Indefinite | Only for patients established on Prolia (denosumab) therapy. To increase bone mass in postmenopausal females with osteoporosis who meet the following criteria: - High risk* for fracture; and - 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 for one year. *High fracture risk is defined as either: - 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; OR - 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. |
| 429 | Indefinite | Only for patients established on Prolia (denosumab) therapy. To increase bone mass in postmenopausal females with osteoporosis who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to hypersensitivity OR abnormalities of the esophagus (e.g., esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - 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; OR - 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. |
| 515 | Indefinite | Only for patients established on Prolia (denosumab) therapy. To increase bone mass in males with osteoporosis who meet the following criteria: - High risk* for fracture; and - 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 for one year. *High fracture risk is defined as either: - 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; OR - 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. |
| 516 | Indefinite | Only for patients established on Prolia (denosumab) therapy. To increase bone mass in males with osteoporosis who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to hypersensitivity OR abnormalities of the esophagus (e.g., esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - 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; OR - 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. |