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Tymlos (abaloparatide) — Blue Cross Blue Shield of Oklahoma

osteoporosis

Initial criteria

  • 1. ONE of the following: A. The patient has been treated with the requested agent (not samples) within past 90 days and is at risk if therapy is changed OR B. The patient has a diagnosis of osteoporosis meeting all of the following diagnostic and demographic criteria.
  • 2. The patient’s sex and age criteria: For males, age ≥50 years or requested agent medically appropriate; For females, postmenopausal or medically appropriate based on menopause status.
  • 3. Osteoporosis diagnosis confirmed by fragility fracture of hip/spine OR T-score ≤ -2.5 OR T-score between -1.0 and -2.5 plus a fragility fracture (proximal humerus, pelvis, distal forearm) OR FRAX 10-year major fracture risk ≥20% OR FRAX 10-year hip fracture risk ≥3%.
  • 4. ONE of the following risk profiles: A. Very high fracture risk (fracture within 12 months, multiple fractures, fractures while on therapy, on skeletal-harming drugs, very low T-score < -3.0, high fall risk, or very high FRAX probability) OR B. Stage four advanced metastatic cancer criteria as documented and FDA approved.
  • 5. The patient has tried and had an inadequate response to a bisphosphonate OR has intolerance/hypersensitivity OR FDA-labeled contraindication to ALL bisphosphonates.
  • 6. The patient will NOT be using the requested agent with bisphosphonate, denosumab, romosozumab-aqqg, or another parathyroid hormone analog (e.g., teriparatide).
  • 7. The patient has no FDA labeled contraindications to the requested agent.
  • 8. Total duration of treatment with FORTEO (teriparatide), Bonsity, Teriparatide, and Tymlos (abaloparatide) has NOT exceeded 2 years lifetime.
  • 9. For Ohio Fully Insured/HIM Shop members: no FDA contraindications AND either FDA-labeled, compendia-supported, or two peer-reviewed articles supporting off-label use.

Reauthorization criteria

  • 1. The patient continues to meet the initial criteria and remains within the 2-year lifetime limit, unless extension is justified by persistent high fracture risk.

Approval duration

12 months (up to total 2 years lifetime)