Limited coverage drugs – denosumab

Generic name

Strength

subcutaneous injection

Special Authority criteria

Approval period

1. For 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

2. For primary prevention of osteoporotic fractures in women with breast cancer who are receiving aromatase inhibitor therapy