Tymlos — Blue Cross Blue Shield of Texas

Initial criteria

• Diagnosis of osteoporosis AND all of the following:
• - For males: age ≥ 50 years OR requested agent medically appropriate for patient’s age and sex
• - For females: postmenopausal OR requested agent medically appropriate for sex and menopause status
• - Diagnosis confirmed by ONE of: fragility fracture in hip or spine OR T-score ≤ -2.5 OR T-score between -1.0 and -2.5 PLUS (fragility fracture of proximal humerus, pelvis, or distal forearm OR FRAX 10-year probability major osteoporotic fracture ≥ 20% OR FRAX 10-year probability hip fracture ≥ 3%)
• - ONE of the following fracture risk criteria:
• • Patient at very high fracture risk defined by at least ONE of: recent fracture within past 12 months OR fractures while on osteoporosis therapy OR multiple fractures OR fractures while on skeletal-harm drugs (e.g., long-term glucocorticoids) OR very low T-score (< -3.0) OR high risk/history of injurious falls OR very high fracture probability by FRAX (major >30%, hip >4.5%) OR other validated risk algorithm
• • OR BOTH: (1) documentation or prescriber statement of stage 4 advanced metastatic cancer with use to treat cancer or associated condition [chart notes required]; AND (2) use consistent with best practices, peer-reviewed evidence, and FDA approval
• - OR Patient has tried and inadequate response to a bisphosphonate (records required)
• - OR intolerance or hypersensitivity to bisphosphonate (records required)
• - OR FDA-labeled contraindication to ALL bisphosphonates (records required)
• Diagnosis of glucocorticoid-induced osteoporosis AND all of the following:
• - Currently initiating or taking glucocorticoids ≥ prednisone 5 mg/day AND expected course ≥ 3 months
• - AND ONE of the following:
• • Patient age < 40 years AND (prior fracture OR glucocorticoids ≥ prednisone 30 mg/day OR cumulative prednisone ≥ 5 g/year)
• • Patient age ≥ 40 years AND (prior osteoporotic fracture OR T-score ≤ -2.5 OR FRAX major ≥ 20% OR FRAX hip ≥ 3% OR glucocorticoids ≥ prednisone 30 mg/day >30 days OR cumulative prednisone ≥ 5 g/year)
• • Tried and inadequate response to a bisphosphonate (records required)
• • Intolerance or hypersensitivity to bisphosphonate (records required)
• • FDA labeled contraindication to all bisphosphonates (records required)
• If request is for brand when generic exists:
• - ONE of the following:
• • Intolerance or hypersensitivity to generic equivalent OR
• • FDA labeled contraindication to generic equivalent OR
• • Support for use of brand over generic AND patient currently stable on brand [chart notes required] OR
• • Tried and inadequate response to generic equivalent OR
• • Generic discontinued due to lack of efficacy, diminished effect, or AE [chart notes required] OR
• • Intolerance, hypersensitivity, contraindication, expected ineffectiveness, significant adherence barrier, worsening comorbidity, decreased function, or adverse reaction/harm from generic [chart notes required]