FORTEO — Blue Cross Blue Shield of Oklahoma

Preferred products

• FORTEO generic equivalent
• Tymlos (abaloparatide)

Initial criteria

• The patient will NOT be using the requested agent in combination with a bisphosphonate, denosumab (e.g., Prolia, Xgeva), romosozumab-aqqg, or another parathyroid hormone analog for osteoporosis (e.g., abaloparatide)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• ONE of the following: (A) Total duration of parathyroid hormone analog therapy for osteoporosis has NOT exceeded 2 years in a lifetime OR (B) Duration has exceeded 2 years AND patient is at high risk of fracture (e.g., T-score, FRAX score, or glucocorticoid use ≥ 5 mg prednisone daily)
• For non-preferred teriparatide products: ALL of the following must be met:
• 1. Osteoporosis diagnosis confirmed by ONE of the following: fragility fracture of hip or spine; T-score ≤ -2.5; or T-score between -1.0 and -2.5 plus either a fragility fracture of proximal humerus, pelvis, or distal forearm OR FRAX 10-year fracture probability ≥ 20% (major) or ≥ 3% (hip)
• 2. Patient sex/menopause/age criteria as applicable: male ≥ 50 years or medically appropriate for age; postmenopausal female or medically appropriate for sex/menopause status
• 3. ONE of the following: (A) Patient at very high fracture risk (e.g., recent fracture ≤ 12 months, fractures while on therapy, multiple fractures, T-score < -3.0, high fall risk, very high FRAX probability) OR (B) Patient meets alternative condition such as advanced metastatic cancer with appropriate documentation OR (C) Has tried and had inadequate response, intolerance, hypersensitivity, or contraindication to bisphosphonates
• 4. For step therapy: ONE of the following: (A) Requested agent is FORTEO generic equivalent OR (B) Patient currently stable on requested agent OR (C) Tried and failed BOTH preferred agents (FORTEO generic equivalent AND Tymlos (abaloparatide)) OR (D) BOTH preferred agents discontinued due to diminished effect or adverse event OR (E) Intolerance/hypersensitivity to BOTH preferred agents OR (F) Contraindication to BOTH preferred agents OR (G) BOTH preferred agents expected to be ineffective or not in best interest of patient OR (H) Tried another drug in same pharmacologic class discontinued for poor response or adverse event
• For glucocorticoid-induced osteoporosis: (A) Patient initiating or currently taking glucocorticoids at ≥ 5 mg/day prednisone equivalent for ≥ 3 months AND (B) For age < 40 years: prior fracture, or prednisone ≥ 30 mg/day, or ≥ 5 g/year cumulative; OR For age ≥ 40 years: prior osteoporotic fracture, T-score ≤ -2.5, FRAX 10-year major fracture ≥ 20% or hip fracture ≥ 3%, or glucocorticoid exposure ≥ 30 mg/day > 30 days or ≥ 5 g/year cumulative

Approval duration

12 months (≤ 2 years lifetime total or 1 year if exceeded 2 years)