Tymlos — Blue Cross Blue Shield of Texas

Initial criteria

• Patient has been treated with requested agent (not samples) within past 90 days and is at risk if therapy changed OR patient has diagnosis of osteoporosis meeting all: (a) male ≥50 years or medically appropriate for age/sex or female postmenopausal or medically appropriate for sex/menopause status; (b) diagnosis confirmed by fragility fracture hip/spine OR T-score ≤ -2.5 OR T-score -1.0 to -2.5 plus fragility fracture of proximal humerus/pelvis/distal forearm OR FRAX 10-year probability major osteoporotic fracture ≥20% OR hip fracture ≥3%; and (c) at very high fracture risk defined by recent ≤12 month fracture, fractures while on therapy, multiple fractures, fractures while on skeletal-harm drugs, very low T-score (<-3.0), high risk for falls, or very high FRAX (major >30% or hip >4.5%)
• Alternatively, prescriber has stated/documented metastatic stage four cancer and requested agent used to treat cancer or associated condition [chart notes required] AND is consistent with best practices supported by evidence-based literature and FDA approval OR inadequate response, intolerance, or contraindication to bisphosphonates
• Patient will NOT be using requested agent in combination with a bisphosphonate, denosumab (Prolia, Xgeva), romosozumab-aqqg, or another parathyroid hormone analog (e.g., teriparatide)
• Patient does NOT have any FDA labeled contraindications
• Total lifetime treatment with FORTEO (teriparatide), Bonsity, Teriparatide, and Tymlos has NOT exceeded 2 years
• Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND patient has no contraindications AND has FDA labeled or compendia supported indication OR prescriber submitted 2 peer-reviewed journal articles supporting proposed use

Approval duration

12 months (up to total 2 years lifetime)