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Ngenla (somatrogon-ghla)CareFirst (Caremark)

Pediatric growth hormone deficiency (pediatric patients aged ≥ 3 years with growth failure due to inadequate secretion of endogenous growth hormone)

Initial criteria

  • Member is pediatric (age ≥ 3 years)
  • Member has a documented diagnosis of growth hormone deficiency as a neonate (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or magnetic resonance imaging [MRI] results) OR Member meets ALL of the following:
  • • Member has either of the following: (a) Two pretreatment pharmacologic provocative GH tests with both results demonstrating a peak GH level < 10 ng/mL OR (b) A documented pituitary or central nervous system (CNS) disorder (see Appendix) AND a pretreatment IGF‑1 level > 2 SD below the mean
  • • Member meets either of the following: (a) Pretreatment height is > 2 SD below the mean and 1‑year height velocity is > 1 SD below the mean OR (b) Pretreatment 1‑year height velocity is > 2 SD below the mean
  • • Epiphyses are open

Reauthorization criteria

  • Member is currently receiving the requested medication or another growth hormone product indicated for pediatric GH deficiency (e.g., Norditropin)
  • Epiphyses are open (confirmed by X‑ray or X‑ray not available)
  • Member’s growth rate is > 2 cm/year unless there is a documented clinical reason for lack of efficacy (e.g., treatment < 1 year, nearing final adult height, or late stages of puberty)

Approval duration

12 months