Nutropin AQ — Cigna

Initial criteria

• Approve for 1 year if ONE of the following (A or B) is met:
• A) Initial therapy. Approve if ONE of the following (i, ii, iii, iv, or v):
• i. Patient meets BOTH of the following (a and b):
• a) Patient meets ONE of the following (1 or 2):
• (1) Two growth hormone stimulation tests performed with levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon AND both tests show a peak growth hormone response < 10 ng/mL; OR
• (2) Has at least one growth hormone stimulation test with any of the above agents AND peak growth hormone response < 10 ng/mL AND has at least one risk factor for growth hormone deficiency (e.g., downward deviation on growth curve, low growth velocity, low IGF-1 or IGFBP-3, optic nerve hypoplasia, GH gene deletion, etc.); AND
• b) Medication prescribed by or in consultation with an endocrinologist; OR
• ii. Patient has undergone brain radiation or tumor resection AND BOTH of the following:
• a) One growth hormone stimulation test with a peak GH response < 10 ng/mL OR deficiency in at least one other pituitary hormone (adrenocorticotropic hormone, thyroid-stimulating hormone, gonadotropin deficiency, prolactin); AND
• b) Medication prescribed by or in consultation with an endocrinologist; OR
• iii. Patient has congenital hypopituitarism AND meets BOTH (a and b):
• a) ONE of the following (1, 2, or 3):
• (1) One growth hormone stimulation test with any of the above agents and peak GH response < 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) Medication prescribed by or in consultation with an endocrinologist; OR
• iv. Patient has multiple pituitary hormone deficiencies AND BOTH (a and b):
• a) ONE of the following (1 or 2):
• (1) Three or more pituitary hormone deficiencies (somatropin, adrenocorticotropic hormone, thyroid-stimulating hormone, gonadotropin deficiency, prolactin); OR
• (2) One growth hormone stimulation test with any of the above agents and peak GH response < 10 ng/mL; AND
• b) Medication prescribed by or in consultation with an endocrinologist; OR
• v. Patient has had a hypophysectomy (surgical removal of pituitary gland).

Reauthorization criteria

• B) Patient is continuing somatropin therapy (established on somatropin for ≥ 10 months). Approve if ONE of the following (i, ii, or iii):
• i. Patient is < 12 years of age AND height has increased by ≥ 2 cm/year in the most recent year; OR
• ii. Patient is ≥ 12 years and < 18 years AND BOTH:
• a) Height increased by ≥ 2 cm/year in the most recent year; AND
• b) Epiphyses are open; OR
• iii. Patient is ≥ 18 years AND ALL:
• a) Height increased by ≥ 2 cm/year in the most recent year; AND
• b) Epiphyses are open; AND
• c) Mid-parental height has not been attained.

Approval duration

1 year