Skytrofa (lonapegsomatropin-tcgd) — CareFirst (Caremark)

Pediatric growth hormone deficiency

Initial criteria

Member is age ≥ 1 year and weighs at least 11.5 kg
EITHER of the following criteria is met:
• Member has a documented diagnosis of GH deficiency as a neonate (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, magnetic resonance imaging [MRI] results)
OR
• Member meets ALL of the following criteria:
• Member has either of the following:
• Two pretreatment pharmacologic provocative GH tests with both results demonstrating a peak GH level < 10 ng/mL
• A documented pituitary or central nervous system (CNS) disorder (see Appendix A) and a pretreatment IGF-1 level > 2 standard deviations (SD) below the mean
• For members < 2.5 years of age at initiation of treatment, the pretreatment height is > 2 SD below the mean and growth velocity is slow
• For members ≥ 2.5 years of age at initiation of treatment, member has either of the following:
• Pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean
• Pretreatment 1-year height velocity is > 2 SD below the mean
• Epiphyses are open

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

12 months