Tymlos (abaloparatide subcutaneous injection – Radius) — Cigna

Initial criteria

• Patient meets ONE of the following (i, ii, or iii):
• i. Patient has had a T-score (current or at any time in the past) at or below -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist); OR
• ii. Patient has had an osteoporotic fracture or a fragility fracture; OR
• iii. Patient meets BOTH of the following (a and b):
• a) Patient has low bone mass (example: T-score between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip, or 33% radius); AND
• b) According to the prescriber, patient is at high risk for fracture; AND
• Patient meets ONE of the following (i, ii, iii, or iv):
• i. Patient has tried zoledronic acid intravenous infusion (Reclast); OR
• ii. Patient has tried at least one oral bisphosphonate or bisphosphonate-containing product and meets ONE of the following (a or b):
• a) According to the prescriber, patient has experienced inadequate efficacy after a trial duration of 12 months; OR
• b) Patient has experienced significant intolerance to an oral bisphosphonate; OR
• iii. Patient cannot take an oral bisphosphonate due to ONE of the following (a, b, or c):
• a) Patient cannot swallow or has difficulty swallowing; OR
• b) Patient cannot remain in an upright position post administration; OR
• c) Patient has a pre-existing gastrointestinal medical condition such as esophageal lesions, ulcers, or esophageal abnormalities; OR
• iv. Patient meets ONE of the following (a or b):
• a) According to the prescriber, patient has severe renal impairment or chronic kidney disease (e.g., creatinine clearance < 35 mL/minute); OR
• b) Patient has had an osteoporotic or fragility fracture.

Approval duration

up to 2 years (total lifetime)