Natpara (parathyroid hormone) — Blue Cross Blue Shield of Alabama
Hypocalcemia associated with hypoparathyroidism
Initial criteria
- Diagnosis of hypocalcemia associated with hypoparathyroidism AND ALL of the following:
- - Baseline (prior to therapy) vitamin D levels above the lower limit of normal
- - Baseline serum calcium level above 7.5 mg/dL
- - Tried and had inadequate response to maximally tolerated calcium AND vitamin D supplements (e.g., calcitriol, ergocalciferol, cholecalciferol)
- - Will continue calcium and vitamin D supplementation with the requested agent
- - Does NOT have hypoparathyroidism caused by calcium-sensing receptor (CaSR) mutations
- - Does NOT have acute post-surgical hypoparathyroidism
- - Does NOT have pseudohypoparathyroidism
- OR has another FDA approved indication for the requested agent
- AND does NOT have increased risk for osteosarcoma (e.g., Paget’s disease of bone, unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, history of external beam or implant radiation of the skeleton, pediatric or young adult with open epiphyses)
- AND will NOT use the requested agent in combination with alendronate
- AND prescriber is a specialist (e.g., endocrinologist, nephrologist) or has consulted with a specialist in the area of diagnosis
- AND patient does NOT have FDA labeled contraindications to the requested agent.
Reauthorization criteria
- Previously approved for the requested agent through plan’s Prior Authorization process AND ONE of the following:
- If diagnosis is hypocalcemia associated with hypoparathyroidism, then ALL of the following:
- - At least 50% reduction from baseline in calcium supplementation dose
- - At least 50% reduction from baseline in vitamin D supplementation dose
- - Albumin-corrected total serum calcium concentration between 8 mg/dL and 9 mg/dL
- - Will continue calcium supplementation with the requested agent
- OR
- If another FDA approved indication, patient has had clinical benefit with requested agent
- AND
- Does NOT have increased risk for osteosarcoma (same risk factors as above)
- AND will NOT use requested agent in combination with alendronate
- AND prescriber is a specialist (e.g., endocrinologist, nephrologist) or has consulted with one
- AND patient does NOT have any FDA labeled contraindications to the requested agent.
Approval duration
initial 6 months; renewal 12 months