Growth Hormone Deficiency in a Child or Adolescent (≥ 2.5 years) — Initial and Ongoing Therapy
Approve for 1 year if the patient meets ONE of the following (A or B).
A or B: A) Initial therapy with any growth hormone agent OR B) Currently receiving Sogroya or switching from another GH agent (established on therapy ≥ 10 months).
See children/adolescent-specific subcriteria
A — Initial Therapy pathway (one of i-v): i) Patient meets BOTH of the following (a and b) OR ii) Brain radiation or tumor resection with testing or other pituitary hormone deficiency OR iii) Congenital hypopituitarism with testing or characteristic imaging or other pituitary hormone deficiency OR iv) Multiple pituitary hormone deficiencies OR v) Hypophysectomy
Each subpath requires medication prescribed by or in consultation with an endocrinologist
A.i — Details for subcriteria (i)
a: (a) Patient meets ONE of the following: (1) At least two GH stimulation tests (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) with peak GH response to both tests < 10 ng/mL; OR (2) At least one GH stimulation test with peak GH response < 10 ng/mL;< 10 ng/mL
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b: (b) Patient has at least one risk factor for growth hormone deficiency (examples: downward deviation across two major height percentiles, growth rate less than expected for age/gender, low IGF-1 and/or IGFBP-3, very low peak GH on provocative testing per prescriber, height velocity < 10th percentile, status post craniopharyngioma resection, optic nerve hypoplasia, GH gene deletion).
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A.ii — Brain radiation or tumor resection pathway: Patient has undergone brain radiation or tumor resection AND meets BOTH of the following: (a) either (1) at least one GH stimulation test with peak GH < 10 ng/mL OR (2) deficiency in at least one other pituitary hormone; AND (b) medication prescribed by or in consultation with an endocrinologist.< 10 ng/mL when testing used
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A.iii — Congenital hypopituitarism pathway: Patient has congenital hypopituitarism AND meets BOTH of the following: (a) one of: (1) at least one GH stimulation test with peak GH < 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.< 10 ng/mL when testing used
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A.iv — Multiple pituitary hormone deficiencies pathway: Patient has multiple pituitary hormone deficiencies (hypopituitarism/panhypopituitarism) and meets BOTH of the following: (a) three or more pituitary hormone deficiencies OR (b) at least one GH stimulation test with peak GH < 10 ng/mL; AND (c) medication prescribed by or in consultation with an endocrinologist.< 10 ng/mL when testing used
Examples include deficiencies of GH, ACTH, TSH, gonadotropins, or prolactin. [chunk 13]
A.v — Hypophysectomy pathway: Patient has had a hypophysectomy (surgical removal of the pituitary gland); medication must be prescribed by or in consultation with an endocrinologist.
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B — Continuation or switch (established on therapy ≥ 10 months): Approve if the patient meets ONE of the following age-based criteria:height increase ≥2 cm/year
Patient must have been established on Sogroya or another GH agent for ≥ 10 months.
B.i — Age < 12 years: Patient is < 12 years of age and height has increased by ≥ 2 cm/year in the most recent year.height increase ≥2 cm/year
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B.ii — Age ≥ 12 and < 18 years: Patient is ≥ 12 and < 18 years of age AND (a) height has increased by ≥ 2 cm/year in the most recent year AND (b) epiphyses are open.height increase ≥2 cm/year
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B.iii — Age ≥ 18 years: Patient is ≥ 18 years of age AND (a) height has increased by ≥ 2 cm/year in the most recent year AND (b) epiphyses are open AND (c) midparental height has not been attained.height increase ≥2 cm/year
Midparental height formula provided in policy. [chunk 11],[chunk 14]