Ngenla (somatrogon-ghla) — Medica

Initial criteria

• age ≥ 3 years AND < 18 years
• Prescribed by or in consultation with an endocrinologist
• AND ONE of the following:
• A) Initial therapy with any growth hormone agent AND ONE of:
• i. BOTH of the following: (a) at least two growth hormone stimulation tests (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with peak GH < 10 ng/mL; OR one such test with peak GH < 10 ng/mL AND at least one risk factor for GH deficiency (e.g., downward crossing height percentiles, low growth rate, low IGF-1/IGFBP-3, post craniopharyngioma resection, optic nerve hypoplasia, GH gene deletion, growth velocity <10th percentile); AND medication prescribed by or in consultation with an endocrinologist
• ii. Underwent brain radiation or tumor resection AND ONE of: (1) one GH stimulation test (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with peak GH < 10 ng/mL; OR (2) deficiency in at least one other pituitary hormone (ACTH, TSH, gonadotropin, prolactin); AND medication prescribed by or in consultation with an endocrinologist
• iii. Congenital hypopituitarism AND ONE of: (1) one GH stimulation test (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with peak GH < 10 ng/mL; OR (2) deficiency in at least one other pituitary hormone (ACTH, TSH, gonadotropin, prolactin); OR (3) imaging triad of ectopic posterior pituitary and pituitary hypoplasia with abnormal pituitary stalk; AND medication prescribed by or in consultation with an endocrinologist
• iv. Multiple pituitary hormone deficiencies (hypopituitarism): (1) three or more of GH, ACTH, TSH, gonadotropin, or prolactin deficiencies; OR (2) one GH stimulation test (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with peak GH < 10 ng/mL; AND medication prescribed by or in consultation with an endocrinologist
• v. Patient has had a hypophysectomy (surgical removal of the pituitary gland)
• B) Patient currently receiving or switching to Ngenla from another growth hormone agent (≥ 10 months of therapy) AND ONE of:
• i. If age < 12 years: height increased ≥ 2 cm/year in the most recent year
• ii. If age ≥ 12 years and < 18 years: height increased ≥ 2 cm/year in the most recent year AND epiphyses open

Reauthorization criteria

• If patient continues on therapy, the same criteria for ongoing response apply:
• age < 12 years: height increased ≥ 2 cm/year in most recent year
• age ≥ 12 years and < 18 years: height increased ≥ 2 cm/year in most recent year AND epiphyses open
• Prescribed by or in consultation with an endocrinologist

Approval duration

1 year