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Tymlos (abaloparatide) — Medica

Osteoporosis treatment for postmenopausal patients

Preferred products

  • Boniva (ibandronate) intravenous injection
  • Reclast (zoledronic acid) intravenous infusion
  • Fosamax (alendronate)
  • Fosamax Plus D (alendronate/cholecalciferol)
  • Actonel (risedronate)
  • Atelvia (risedronate)
  • Boniva (ibandronate) tablets

Initial criteria

  • Approve for up to 2 years (total) during a patient’s lifetime if ALL of the following (A and B) are met:
  • A) Patient meets ONE of the following conditions (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% radius (wrist); OR
  • ii. Patient has had an osteoporotic fracture or a fragility fracture; OR
  • iii. Patient has low bone mass (T-score between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% radius [wrist]) AND according to the prescriber, patient is at high risk for fracture; AND
  • B) Patient meets ONE of the following (i, ii, iii, or iv):
  • i. Patient has tried ibandronate intravenous injection (Boniva) or zoledronic acid intravenous infusion (Reclast); OR
  • ii. Patient has tried at least one oral bisphosphonate (Fosamax, Fosamax Plus D, Actonel, Atelvia, or Boniva) AND either (a) has experienced inadequate efficacy after a 12-month trial (e.g., ongoing bone mineral density loss, lack of increase, or new osteoporotic/fragility fracture) OR (b) has experienced significant intolerance (e.g., severe gastrointestinal or musculoskeletal adverse events); OR
  • iii. Patient cannot take an oral bisphosphonate due to one of the following: cannot swallow or difficulty swallowing, cannot remain upright post dose, or has a pre-existing gastrointestinal medical condition (e.g., esophageal lesion, ulcer, or motility abnormality); OR
  • iv. Patient has severe renal impairment (creatinine clearance <35 mL/min), chronic kidney disease, or has had an osteoporotic or fragility fracture.

Reauthorization criteria

  • Reauthorization up to lifetime total of 2 years permitted if cumulative use (including previous Tymlos therapy) does not exceed 2 years.

Approval duration

up to 2 years (lifetime total)