Tymlos — Blue Cross Blue Shield of New Mexico

Initial criteria

• Diagnosis of osteoporosis AND all of the following: (a) if male: age ≥ 50 years OR requested agent medically appropriate for age and sex; (b) if female: postmenopausal OR requested agent medically appropriate for sex and menopause status;
• Diagnosis confirmed by ONE of the following: (a) fragility fracture in hip or spine OR (b) T-score ≤ -2.5 OR (c) T-score between -1.0 and -2.5 AND (1) fragility fracture of proximal humerus, pelvis, or distal forearm OR (2) FRAX 10-year major osteoporotic fracture probability ≥ 20% OR (3) FRAX 10-year hip fracture probability ≥ 3%;
• ONE of the following: (a) patient at very high fracture risk defined by ONE of: recent fracture (within 12 months) OR fractures while on FDA-labeled osteoporosis therapy OR multiple fractures OR fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR T-score < -3.0 OR at high risk for falls or history of injurious falls OR very high fracture probability by FRAX (major osteoporotic fracture >30% or hip fracture >4.5%) or other validated algorithm; OR (b) patient meets ONE of the following: (1) diagnosis of stage 4 advanced metastatic cancer and agent used to treat the cancer or related condition per supporting literature and FDA labeling; OR (2) tried and inadequate response to bisphosphonate; OR (3) intolerance or hypersensitivity to bisphosphonate; OR (4) FDA labeled contraindication to all bisphosphonates.
• Diagnosis of glucocorticoid-induced osteoporosis AND all of the following: (a) initiating or currently taking glucocorticoids ≥5 mg prednisone equivalent daily AND (b) expected course ≥3 months AND (c) ONE of: (1) if <40 years: prior fracture OR glucocorticoids ≥30 mg/day prednisone equivalent OR cumulative ≥5 g/year; OR (2) if ≥40 years: prior osteoporotic fracture OR T-score ≤ -2.5 OR FRAX 10-year major osteoporotic fracture ≥20% OR FRAX 10-year hip fracture ≥3% OR glucocorticoids ≥30 mg/day for >30 days OR cumulative ≥5 g/year; OR (3) tried and inadequate response to bisphosphonate OR (4) intolerance/hypersensitivity to bisphosphonate OR (5) contraindication to all bisphosphonates.
• If brand agent requested when generic equivalent available, ONE of the following: (a) intolerance/hypersensitivity to generic equivalent not expected with brand; OR (b) FDA labeled contraindication to generic equivalent not expected with brand; OR (c) support for brand agent use AND patient currently stable on brand; OR (d) tried and inadequate response to generic; OR (e) generic discontinued due to lack of efficacy, diminished effect, or adverse event; OR (f) intolerance/hypersensitivity to generic not expected with requested agent; OR (g) FDA labeled contraindication to generic not expected with requested agent; OR (h) generic expected to be ineffective, cause adherence barrier, worsen comorbid condition, decrease functional ability, or cause adverse reaction or harm.