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Sogroya (somapacitan-beco subcutaneous injection) — Cigna

Growth Hormone Deficiency in a Child or Adolescent (age ≥ 2.5 years)

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 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 is < 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 such as: downward deviation across two major height percentiles, growth rate less than expected based on age and gender, low insulin-like growth factor (IGF)-1 and/or IGFBP-3 levels, very low peak GH on testing, growth velocity less than 10th percentile for age and gender, status post craniopharyngioma resection, optic nerve hypoplasia, or growth hormone gene deletion; AND
  • 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 ONE of the following [(1) or (2)]:
  • (1) 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 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], or prolactin); AND
  • b) The medication has been prescribed by or in consultation with an endocrinologist; OR
  • iii. Patient has congenital hypopituitarism AND meets BOTH of the following (a and b) (details continue in later text).

Approval duration

1 year