Somatropin — United Healthcare
Transition Phase Adolescent Growth Hormone Deficiency
Initial criteria
- One of the following: (a) Genetic mutation OR (b) Deficiency of three of the following anterior pituitary hormones: ACTH, TSH, Prolactin, FSH/LH OR (c) Irreversible structural hypothalamic-pituitary disease OR (d) Panhypopituitarism
- AND one of the following: (a) IGF-1 level below the age and gender adjusted normal range per physician lab OR (b) BOTH: (i) Patient has undergone one of the following GH stimulation tests after discontinuation of therapy ≥1 month: Insulin tolerance test (ITT), GH-releasing hormone-arginine test, Glucagon stimulation test, Macimorelin AND (ii) Peak GH values meeting criteria: ITT ≤5.1 µg/L, GHRH+ARG ≤11 µg/L, Glucagon ≤3 µg/L, or Macimorelin ≤2.8 ng/mL
Reauthorization criteria
- Documentation of positive response to therapy (e.g., increase in total lean body mass, exercise capacity or IGF-1 and IGFBP-3 levels)
Approval duration
12 months