Ngenla — United Healthcare

Initial criteria

• Diagnosis of pediatric GH deficiency
• Evidence of growth failure confirmed by ALL of the following: (a) Growth charts for length/height and weight for age and gender with evidence of growth velocity deceleration over time; (b) Documentation of length/height and weight for age and gender including percentile and/or standard deviation scores; (c) Calculated growth velocity
• Documentation of open epiphyses in the last 12 months
• Tanner stage ≤ 4
• Documentation of BOTH: (a) Patient has undergone two of the following provocative GH stimulation tests: Arginine, Clonidine, Glucagon, Insulin, Levodopa AND (b) Peak GH responses to each agent is < 10 mcg/L
• If history of malignancy, documentation that patient is in remission OR patient stable for ≥12 months

Reauthorization criteria

• Height increase of at least 2 cm/year over the previous year documented by ALL of: (a) Previous length/height and date obtained; (b) Current length/height and date obtained; (c) Calculated growth velocity; (d) Growth chart for length/height for age and gender
• BOTH: (a) Expected adult height not attained AND (b) Documentation of expected adult height goal (e.g., genetic potential)

Approval duration

12 months