Teriparatide (Forteo)

JCODE: J3110

SELF ADMININISTRATION

FDA Approved Indications:

  • Treatment of osteoporosis in postmenopausal women who are at high risk for fracture
  • To increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture
  • Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture

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 facture while on bisphosphonate therapy or Prolia, OR
    • B) Patient had an inadequate respone, 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 a statistically/clinically significant (e.g. 4 – 5%) decrease in absolute bone density or occurrences of osteoporotic fractures despite therapy (documentation required). Patient is intolerant to oral or IV bisphosphonate

Coverage is NOT authorized For:

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

Dosing:

  • Twenty micrograms (20 mcg) given subcutaneously in the abdomen or thigh once a day
  • This medication should be given with calcium 1,000 mg per day and Vitamin D 400-1200 IU per day
  • The initial dose should be given under circumstances where the patient can sit or lie down if orthostatic hypotension occurs
  • If patient develops hypocalcaemia, discontinue the calcium supplementation and/or reduce Forteo dose by half

Monitoring:

  • Calcium levels should be monitored before the injection and at 4 and 6 hours after the initial injection. Repeat lab every 3 months for 24 months

Approval:

  • One year to assess patient’s response. Approve treatment for a maximum of  2 years

 

Last review date: December 2, 2013

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