Evenity™

Drug - Evenity™ (romosozumab-aqqg) [Amgen Inc.]

July 2019

Therapeutic area - Osteoporosis

Approval criteria

Patient is at least 18 years of age AND
Patient has a documented diagnosis of osteoporosis indicated by 1 or more of the following:
- Hip dual-energy x-ray absorptiometry (DXA) (femoral neck or total hip) or lumbar spine T-score of ≤ -2.5 and/or forearm DXA 33% (one-third) radius OR
- T-score ≤ -1 or low bone mass AND a history of fragility fracture to the hip or spine OR
- T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥ 20% or hip fracture ≥3% AND
Patient must be at a high risk for fracture, which is defined as having at least ONE of the following:
- History of an osteoporotic fracture as an adult
- Parental history of hip fracture
- Low BMI
- Rheumatoid arthritis
- Alcohol intake (3 or more drinks per day)
- Current smoking
- History of oral glucocorticoids ≥ 5 mg/day of prednisone (or equivalent) for > 3 months

AND

Patient must be post-menopausal AND
Documented treatment failure or ineffective response to a minimum 12-month trial on previous therapy with bisphosphonates (oral or intravenous [IV]) such as alendronate, risedronate, ibandronate, or zoledronic acid OR
- Patient has a documented contraindication or intolerance to BOTH oral bisphosphonates AND IV bisphosphonates OR
- Patient has extremely low bone mineral density (BMD) defined as a T-score < -3.5 or a T-score < -2.5 with a history of fragility fractures AND
Documented treatment failure or ineffective response to a minimum 12-month trial on previous therapy with RANKL-blocking agents such as denosumab OR
- Patient has a documented contraindication or intolerance to RANKL-blocking agents OR
- Patient has extremely low bone mineral density (BMD) defined as a T-score < -3.5 or a T-score < -2.5 with a history of fragility fractures AND
Patient must be supplementing with 1,000 mg of calcium and at least 400 IU of vitamin D daily AND
Patient must not have hypocalcemia AND
Patient has not had a myocardial infarction or stroke within the preceding year
Approval is for 12 months; may not renew

MHCP Provider Call Center 651-431-2700 or 800-366-5411