Tymlos Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Tymlos will be approved when ALL of the following are met:

1. The patient has ONE of the following:
   1. Postmenopausal osteoporosis
      OR
   2. Patient’s sex is male with osteoporosis
      AND
2. BOTH of the following:
   1. 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 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
   2. 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., longterm 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 
3. 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., teriparatide) for the requested indication
   AND
4. The requested dose is within FDA labeled dosing for the requested indication   
   AND
5. The total cumulative duration of treatment with teriparatide and Tymlos (abaloparatide) has not exceeded 2 years

Length of approval:
No prior Tymlos and/or teriparatide use approve 2 years
Prior Tymlos and/or teriparatide use approve remainder of 2 years of total cumulative therapy