ROMOSOZUMAB-AQQG INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Patient had a myocardial infarction or stroke within the past year
- Pregnancy (known pregnancy or positive pregnancy test), or lactating
- Hypocalcemia or pre-existing disturbance of mineral metabolism that has not been effectively corrected or treated (e.g., hypoparathyroidism, thyroid or parathyroid surgery, vitamin D deficiency, malabsorption syndromes, excision of small intestine)
- Exception: Patients with secondary or tertiary hyperparathyroidism due to chronic kidney disease and low bone mineral density who are nonsurgical candidates
- Documentation of the need for an invasive dental procedure (e.g., tooth extraction, dental implant, and/or dental infection treatment) or recent procedure that has not fully healed
- Acute dental issue identified by history or clinician mouth examination
- Previous cumulative 12-month exposure to romosozumab
Inclusion Criteria
- Patient has a diagnosis of osteoporosis
- Prescriber is a VA or VA Community Care endocrinologist, rheumatologist, nephrologist, geriatrician, or locally designated expert
- Patient’s total daily dietary and supplemental calcium intake is 1000 to 1200 mg/day
- Has a 25-hydroxyvitamin D concentration >30 ng/mL or > 20 ng/ml with appropriate intake (e.g., cholecalciferol >800 international units per day)
- Following a one-year course of romosozumab, start antiresorptive therapy to maintain bone density gains
- Additional Inclusion Criteria (One of the following must be met)
- Osteoporotic fracture and a T-score at the hip or spine of < -2.5
- Very high fracture probability by the Fracture Risk Assessment Tool (FRAX) (e.g., major osteoporosis fracture >30%, hip fracture >4.5%)
- Patient has a T-score < -3.0
- More than 2 osteoporotic fractures
- Continuing to lose bone mineral density or sustained an osteoporotic fracture while on approved osteoporosis therapy