TYMLOS (abaloparatide) — Blue Cross Blue Shield of Kansas

Initial criteria

• A. Patient has osteoporosis diagnosis confirmed by ONE of the following: A fragility fracture in the hip or spine OR a T-score of -2.5 or lower OR a T-score of -1.0 to -2.5 AND ONE of the following: fragility fracture of proximal humerus, pelvis, or distal forearm OR FRAX 10-year probability for major osteoporotic fracture ≥ 20% OR FRAX 10-year probability of hip fracture ≥ 3%
• AND ONE of the following: patient is at very high fracture risk (recent fracture within 12 months OR fractures while on FDA labeled osteoporosis therapy OR multiple fractures OR fractures while on drugs causing skeletal harm OR T-score < -3.0 OR high risk for falls OR very high FRAX probability ≥ 30% major or ≥ 4.5% hip) OR patient has tried and had inadequate response to a bisphosphonate OR intolerance/hypersensitivity to a bisphosphonate OR FDA labeled contraindication to all bisphosphonates
• AND BOTH of the following: patient has tried/failed, intolerant, or has contraindication to FORTEO generic equivalent that is not expected to occur with requested agent AND tried/failed, intolerant, or contraindicated to TYMLOS (abaloparatide)
• OR patient has diagnosis of glucocorticoid-induced osteoporosis AND ALL of the following: currently taking or initiating glucocorticoid dose ≥ 5 mg prednisone daily AND expected course ≥ 3 months AND ONE of: (A) patient < age 40 years AND either prior fracture OR prednisone ≥ 30 mg/day OR cumulative ≥ 5 g/year, OR (B) patient age ≥ 40 years AND one of: prior osteoporotic fracture OR T-score ≤ -2.5 OR FRAX major osteoporotic fracture ≥ 20% OR FRAX hip ≥ 3% OR prednisone ≥ 30 mg/day for >30 days OR cumulative ≥ 5 g/year) AND patient has tried/failed, intolerant, or contraindicated to bisphosphonates AND to FORTEO generic equivalent
• AND patient will NOT use requested agent in combination with bisphosphonate, denosumab (Prolia, Xgeva), romosozumab-aqqg, or another parathyroid hormone analog (e.g., abaloparatide)
• AND patient does NOT have FDA labeled contraindications to requested agent
• AND ONE of the following: total duration of parathyroid hormone analog use ≤ 2 years lifetime OR >2 years lifetime AND patient at high risk of fracture (e.g., low T-score, high FRAX, or continued glucocorticoid use)

Approval duration

remainder of 2 years lifetime if total <2 years; 1 year if ≥2 years and high risk