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Skytrofa (lonapegsomatropin subcutaneous injection) — Cigna

Growth Hormone Deficiency in a Pediatric Patient (age ≥ 1 year)

Initial criteria

  • Approve for 1 year if ONE of the following (A or B) is met:
  • A) Initial Therapy with any Growth Hormone Agent. Approve if ONE of the following (i, ii, iii, iv, or v) is met:
  • i. Patient meets BOTH of the following (a and b):
  • a) Patient meets at least ONE of the following [(1) or (2)]:
  • (1) Patient has had at least two growth hormone stimulation tests performed with levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon AND the peak growth hormone response to both tests are < 10 ng/mL; OR
  • (2) Patient meets BOTH of the following [(a) and (b)]:
  • (a) Patient has had at least one growth hormone stimulation test performed with levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon AND the peak growth hormone response to at least one test is < 10 ng/mL; AND
  • (b) Patient has at least one risk factor for growth hormone deficiency;
  • Note: Examples of at least one risk factor for growth hormone deficiency include: the height-for-age curve has deviated downward across two major height percentiles; growth rate is less than expected for age and gender; low IGF-1 or IGFBP3 levels; very low peak GH level on provocative testing as defined by the physician; growth velocity < 10th percentile for age/gender; patient is status post craniopharyngioma resection; optic nerve hypoplasia; or GH gene deletion.
  • b) The medication has been prescribed by or in consultation with an endocrinologist; OR
  • ii. Patient has undergone brain radiation or tumor resection AND meets BOTH of the following (a and b):
  • a) Patient meets at least ONE of the following [(1) or (2)]:
  • (1) Patient meets BOTH of the following [(i) and (ii)]:
  • (i) Patient has had one growth hormone stimulation test with levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon; AND
  • (ii) The peak growth hormone response to at least one test is < 10 ng/mL; OR
  • (2) Patient has a deficiency in at least one other pituitary hormone (adrenocorticotropic hormone, thyroid-stimulating hormone, gonadotropin [luteinizing hormone and/or follicle-stimulating hormone counted as one deficiency], or prolactin).

Approval duration

1 year