Tymlos (abaloparatide subcutaneous injection – Radius) — Medical Mutual

Initial criteria

• Patient has T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or 33% radius OR patient has had an osteoporotic or fragility fracture OR patient has low bone mass (T-score between -1.0 and -2.5) and physician determines high risk for fracture AND
• Patient has tried one oral bisphosphonate or bisphosphonate-containing product with inadequate response after ≥ 12 months OR osteoporotic fracture during therapy OR intolerability (e.g. severe GI or musculoskeletal adverse effects, femoral fracture) OR
• Patient cannot take oral bisphosphonate due to inability to swallow, inability to remain upright, or pre-existing GI condition (esophageal lesions/ulcers/stricture/achalasia) OR
• Patient has tried ibandronate injection (Boniva) or zoledronic acid injection (Reclast) OR
• Patient has severe renal impairment (CrCl < 35 mL/min) OR chronic kidney disease OR osteoporotic/fragility fracture AND
• Use of teriparatide and/or Tymlos does not exceed 2 years during lifetime

Approval duration

1 year (initial and reauth); total max 2 years lifetime