Tymlos (abaloparatide) — Blue Cross Blue Shield of Montana

Initial criteria

• 1. ONE of the following: (A) patient has been treated with Tymlos within the past 90 days (samples not acceptable) and is at risk if therapy is changed OR (B) patient has a diagnosis of osteoporosis meeting all of the following:
• a. For males: age ≥50 years OR therapy is medically appropriate for age/sex; for females: postmenopausal OR therapy appropriate for sex/menopause status
• b. Diagnosis confirmed by ONE of: (1) fragility fracture in hip or spine OR (2) T‑score ≤‑2.5 OR (3) T‑score between ‑1.0 and ‑2.5 plus (i) fragility fracture of proximal humerus, pelvis, or distal forearm OR (ii) FRAX 10‑year major osteoporotic fracture probability ≥20% OR (iii) FRAX 10‑year hip fracture probability ≥3%
• c. ONE of: (1) patient is at very high fracture risk defined by recent fracture (within 12 months), fractures while on therapy, multiple fractures, fractures on drugs causing skeletal harm (e.g., long‑term glucocorticoids), very low T‑score (<‑3.0), high fall risk, or very high FRAX risk (major fracture >30% or hip fracture >4.5%) OR
• (2) stage four advanced metastatic cancer criteria similar to FORTEO section (documentation of cancer and appropriate evidential support) OR inadequate response/intolerance/contraindication to bisphosphonates noted above.
• 2. The patient will NOT use Tymlos in combination with a bisphosphonate, denosumab (e.g., Prolia, Xgeva), romosozumab‑aqqg, or another parathyroid hormone analog (e.g., teriparatide).
• 3. The patient does NOT have any FDA labeled contraindications to Tymlos.
• 4. Total lifetime use of parathyroid hormone analogs (FORTEO, Bonsity, Teriparatide, Tymlos) has NOT exceeded 2 years.

Reauthorization criteria

• Continuation may be approved if patient remains stable on therapy, no contraindications, no concurrent therapy with bisphosphonate/denosumab/romosozumab/other PTH analog, and total treatment time ≤2 years lifetime.

Approval duration

12 months (up to lifetime total 2 years)