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palopegteriparatide — Blue Cross Blue Shield of Texas

hypoparathyroidism

Initial criteria

  • 1. ONE of the following: A. ALL of the following: 1. The patient has a diagnosis of hypoparathyroidism AND 2. The patient does NOT have acute post-surgical hypoparathyroidism AND 3. The patient does NOT have pseudohypoparathyroidism AND 4. If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. There is support for using the requested agent for the patient’s age for the requested indication AND 5. The patient has baseline albumin-corrected serum calcium ≥ 7.8 mg/dL using calcium and active vitamin D treatment AND 6. The patient has baseline vitamin D levels above the lower limit of normal AND 7. The patient has tried and had an inadequate response to maximally tolerated calcium AND vitamin D supplements (e.g., calcitriol, ergocalciferol, cholecalciferol)
  • 2. The patient will continue calcium and vitamin D supplementation while titrating to an appropriate dose of the requested agent
  • 3. The patient will NOT use the requested agent in combination with denosumab, estrogen, raloxifene, or Sensipar (cinacalcet)
  • 4. The prescriber is a specialist in, or has consulted with, an endocrinologist or nephrologist
  • 5. The patient does NOT have any FDA labeled contraindications to the requested agent
  • Alternate approval: The member resides in Ohio AND The plan is Fully Insured or HIM Shop (SG) AND The patient does not have FDA labeled contraindications AND ONE of the following: (A) patient has another FDA labeled indication and route of administration OR (B) indication supported by compendia OR (C) prescriber submitted two peer-reviewed journal articles supporting proposed use

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • 2. The patient has an albumin-corrected total serum calcium concentration between 8.3 and 10.6 mg/dL
  • 3. The patient has had clinical benefit with the requested agent
  • 4. The patient will NOT use the requested agent in combination with denosumab, estrogen, raloxifene, or Sensipar (cinacalcet)
  • 5. The prescriber is a specialist in, or has consulted with, an endocrinologist or nephrologist
  • 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSOK: 36 months; BCBSIL/BCBSMT: 12 months; All other plans: 6 months (initial) / BCBSOK: 36 months; All other plans: 12 months (renewal)