Teriparatide Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Teriparatide 620 mcg/2.48 mL will be approved when ALL of the following are met:

1. The patient has ONE of the following:

   1. Postmenopausal osteoporosis
      OR
   2. The patient’s sex is male with primary or hypogonadal osteoporosis
      OR
   3. Osteoporosis with sustained systemic glucocorticoid therapy
      AND

2. The patient’s diagnosis was confirmed by ONE of the following:

   1. A fragility fracture in the hip or spine
      OR

   2. A T-score of -2.5 or lower
      OR

   3. A T-score of -1.0 to -2.5 AND ONE of the following:

      1. A fragility fracture of the proximal humerus, pelvis, or distal forearm
         OR
      2. A FRAX 10-year probability for major osteoporotic fracture of 20% or greater
         OR
      3. A FRAX 10-year probability of hip fracture of 3% or greater
         AND

3. ONE of the following:

   1. The patient is at a very high fracture risk as defined by ONE of the following:

      1. Patient had a recent fracture (within the past 12 months)
         OR
      2. Patient had fractures while on FDA approved osteoporosis therapy
         OR
      3. Patient has had multiple fractures
         OR
      4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids)
         OR
      5. Patient has a very low T-score (less than -3.0)
         OR
      6. Patient is at high risk for falls or has a history of injurious falls
         OR
      7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm
         OR

   2. ONE of the following:

      1. The patient has tried and had an inadequate response to a bisphosphonate
         OR
      2. The patient has an intolerance or hypersensitivity to a bisphosphonate
         OR
      3. The patient has an FDA labeled contraindication to a bisphosphonate
         AND

4. The patient will NOT be using the requested medication in combination with a bisphosphonate, denosumab (e.g., Prolia, Xgeva), Evenity (romosozumab-aqqg), or another parathyroid hormone analog (e.g., abaloparatide) for the requested indication
   AND

5. The requested dose is within FDA labeled dosing for the requested indication
   AND

6. ONE of the following:

   1. The patient has never received treatment with teriparatide or Tymlos (abaloparatide)
      OR

   2. The patient has been previously treated with teriparatide or Tymlos (abaloparatide) AND ONE of the following:

      1. The total cumulative duration of treatment with teriparatide and Tymlos (abaloparatide) has NOT exceeded 2 years
         OR
      2. The patient has received 2 years or more of treatment with teriparatide, or a combination of teriparatide and Tymlos (abaloparatide), and remains at or has returned to having a high risk for fracture

Length of Approval:

No prior Forteo or teriparatide and/or Tymlos use - approve 2 years

Prior Forteo or teriparatide and/or Tymlos (abaloparatide) use - approve remainder of 2 years of total cumulative therapy

Two years or more of Forteo or teriparatide (or teriparatide + Tymlos) use – approve 1 year