Abaloparatide (Tymlos)

SELF ADMINISTRATION

FDA Approved Indications:

Indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have falied or are intolerant to other available osteopororis therapy

Indications for Prior Authorization:

  • One of the following (1, 2 or 3):
    • 1) One or more non-traumatic fractures as evident by chart notes, OR
    • 2) Evidence of radiographic fractures, OR
    • 3) T-score less than or equal to -2.5SD, AND
  • One of the following (A, B or C):
    • A) Patient had a non-traumatic fracture while on bisphosphonate therapy or Prolia, OR
    • B) Patient had an inadequate response, as evidenced by documented worsening BMD, following at least one year of therapy with a bisphosphonate AND an additional year of treatment with Prolia, OR
    • C) Patient had an intolerable side effect or contraindication to both oral and IV bisphosphonate therapy AND an intolerable side effect or contraindication to Prolia
  • Treatment failure* to a bisphosphonate in patients with either a history of vertebral fracture, a low or atraumatic non-vertebral fracture, or a BMD t-score worse than -2.5 SD (baseline DEXA is required for all approvals)
  • *Treatment failure is defined as statistically/clinically significant (e.g. 4-5%) decrease in absolute bone denisty or occurrences of osteoporotic fractures despite therapy (documentation required).  Patient is intolerant to oral or IV bisphosphonate.

Coverage is NOT authorized for:

  • Comination therapy with bisphosphonate, Evista, calcitonin, Prolia or Forteo
  • Treatment of Hypoparathyroidism
  • Non-FDA approved indications unless there is a sufficient documentation of efficiacy and safety in the published literature

Dosing:

  • 80 mcg subcutaneously once daily
  • Cumulative use of Tymlos and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended
  • This medication should be given with supplemental calcium and vitamin D if dietary intake is inadequate
  • The initial dose should be given under circumstances where the patient can sit or lie down if orthostatic hypotension occurs

Approval:

  • One year to assess patient's response.  Approve treatment of all parathyroid hormone analogs to a combined maximum of 2 years.