ABALOPARATIDE INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- History of hypersensitivity reaction or contraindication to abaloparatide (including Paget’s disease, hyper or hypocalcemia, hypercalciuria, bone cancer, bone metastases, radiation treatment to the skeleton, and hyperparathyroidism)
- Pregnancy or lactating status
- Lifetime receipt of 2 years of treatment with abaloparatide
Inclusion Criteria (All must be met)
- Diagnosis of osteoporosis or at risk for glucocorticoid-induced osteoporosis
- Prescriber is a VA/Community Care endocrinologist, rheumatologist, nephrologist, geriatrician, or locally designated expert
- Total daily dietary and supplemental calcium intake of 1000 to 1200 mg/day
- 25-hydroxyvitamin D concentration >30 ng/mL or >20 ng/mL with appropriate intake (e.g., cholecalciferol >800 international units per day)
Additional Inclusion Criteria (One must be met)
- Osteoporotic fracture and a T-score at the hip or spine of < -2.5
- Very high fracture probability by Fracture Risk Assessment Tool (FRAX) (e.g., major osteoporosis fracture >30%, hip fracture >4.5%)
- T-score < -3.0
- More than 2 osteoporotic fractures
- Continued loss of bone mineral density or sustained osteoporotic fracture despite treatment with an approved osteoporosis therapy (e.g., bisphosphonate or denosumab)
Post-Treatment Requirement
- Following a 2-year course of abaloparatide, initiate antiresorptive therapy to maintain bone density gains.