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Ngenla (somatrogon-ghla subcutaneous injection - Pfizer) — Cigna

Growth hormone deficiency in a pediatric patient (age ≥ 3 years to < 18 years)

Initial criteria

  • Approve for 1 year if the patient meets ONE of the following (A or B):
  • A) Initial therapy with any growth hormone agent. Approve if the patient meets ONE of the following (i, ii, iii, iv, or v):
  • 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 any of the following agents: 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 any of the following agents: 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 (examples include decreased height-for-age percentile, low growth velocity, low IGF-1 or IGFBP-3 levels, 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 at least ONE of the following [(1) or (2)]: (1) Patient has had one growth hormone stimulation test with any of the following agents: levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon AND 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, 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):
  • a) Patient meets at least ONE of the following [(1), (2), or (3)]: (1) One growth hormone stimulation test showing peak < 10 ng/mL; OR (2) Deficiency in at least one other pituitary hormone; OR (3) Imaging triad of ectopic posterior pituitary and pituitary hypoplasia with abnormal pituitary stalk; AND
  • b) The medication has been prescribed by or in consultation with an endocrinologist; OR
  • iv. Patient has multiple pituitary hormone deficiencies AND meets BOTH of the following (a and b):
  • a) Patient meets at least ONE of the following [(1) or (2)]: (1) Three or more of the following deficiencies: somatropin (growth hormone), adrenocorticotropic hormone, thyroid-stimulating hormone, gonadotropin, and prolactin; OR (2) One stimulation test showing peak growth hormone < 10 ng/mL; AND
  • b) The medication has been prescribed by or in consultation with an endocrinologist; OR
  • v. Patient has had a hypophysectomy (surgical removal of pituitary gland); OR
  • B) Patient is currently receiving Ngenla or is switching to Ngenla from another growth hormone agent (patient has been established on either therapy for ≥ 10 months). Approve if the patient meets ONE of the following (i or ii):
  • i. Patient is < 12 years of age: Patient’s height has increased by ≥ 2 cm/year in the most recent year; OR
  • ii. Patient is ≥ 12 years of age and < 18 years of age: Patient meets BOTH of the following (a and b): (a) Patient’s height has increased by ≥ 2 cm/year in the most recent year; AND (b) Patient is still growing (epiphyseal plates not closed)

Approval duration

1 year