Tymlos (abaloparatide) — Blue Cross Blue Shield of Illinois

Initial criteria

• ONE of the following:
• 1. The patient has been treated with the requested agent within the past 90 days (samples excluded) and is at risk if therapy is changed OR
• 2. The patient has a diagnosis of osteoporosis AND ALL of the following:
• a. For males: age ≥ 50 years OR agent is medically appropriate for age and sex; for females: postmenopausal OR agent is medically appropriate for sex and menopause status
• b. Diagnosis confirmed by ONE of the following: i. Fragility fracture in the hip or spine OR ii. T-score ≤ -2.5 OR iii. T-score between -1.0 and -2.5 and either fragility fracture (proximal humerus, pelvis, distal forearm) OR FRAX 10-year probability ≥20% major osteoporotic fracture OR ≥3% hip fracture
• c. ONE of the following: i. At very high fracture risk (recent fracture ≤12 months, fractures on therapy, multiple fractures, fractures on glucocorticoids, T-score < -3.0, high fall risk, FRAX >30% or >4.5% hip) OR ii. (For metastatic cancer scenario) BOTH of the following: A. Diagnosed with stage four advanced metastatic cancer with the requested agent used to treat the cancer or associated condition [chart notes required] AND B. Use is consistent with best practices, peer-reviewed evidence, and FDA approved for that condition OR iii. Patient has tried and had inadequate response to a bisphosphonate OR intolerance/hypersensitivity to a bisphosphonate OR contraindication to bisphosphonates
• The patient will NOT use the requested agent in combination with a bisphosphonate, denosumab (Prolia, Xgeva), romosozumab-aqqg, or another parathyroid hormone analog (e.g., teriparatide) AND
• The patient does NOT have any FDA labeled contraindications to the requested agent AND
• The total duration of treatment with FORTEO (teriparatide), Bonsity, Teriparatide, and Tymlos (abaloparatide) has NOT exceeded 2 years in a lifetime

Approval duration

12 months (up to total 2 years lifetime)