Evenity (romosozumab-aqqg) — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years
• Patient is receiving calcium and Vitamin D supplementation if dietary intake is inadequate
• Patient must not have hypocalcemia
• Patient has not had a myocardial infarction or stroke within the preceding year
• Will not be used in combination with bisphosphonates, denosumab, or parathyroid hormone analogs/related peptides
• Patient must be at a high risk for fracture
• Patient has a documented diagnosis of osteoporosis indicated by one or more of the following: T-score by DXA of ≤ -2.5 in the lumbar spine, femoral neck, total hip or forearm at the 33% radius site OR history of fragility fracture to the hip or spine regardless of T-score OR T-score between -1.0 and -2.5 along with history of fracture of proximal humerus, pelvis, or distal forearm OR FRAX 10-year probability for major fracture ≥ 20% or hip fracture ≥ 3%
• Patient has documented treatment failure or ineffective response to a minimum 12-month trial on previous therapy with bisphosphonates (oral or IV) OR documented contraindication or intolerance to BOTH oral bisphosphonates AND IV bisphosphonates
• Patient has documented treatment failure or ineffective response to a minimum 12-month trial on previous therapy with RANKL-blocking agents (e.g., denosumab) OR documented contraindication or intolerance to RANKL-blocking agents
• Patients with very high risk for fracture defined as T-score ≤ -3.0, or T-score ≤ -2.5 with a history of fragility fractures, or severe or multiple vertebral fractures are not subject to prior trial and failure requirements with bisphosphonates and/or denosumab

Reauthorization criteria

• Duration of authorization has not been exceeded (maximum 12 months total)

Approval duration

12 months (non-renewable)