Increlex (mecasermin) — Highmark

Severe primary insulin-like growth factor-1 (IGF-1) deficiency

Initial criteria

Diagnosis of severe primary IGF-1 deficiency (ICD-10 code: E34.321)
Normal or elevated response (> 10 ng/mL) to two of the following growth hormone stimulation tests: arginine, clonidine, glucagon, insulin, levodopa, or propranolol
Serum IGF-1 concentration ≤ 3 standard deviations below the normal value based on laboratory reference range
Height ≤ 3 standard deviations below normal (at or below the third percentile for gender and age)
Bone age limits: if female, bone age ≤ 14 years; if male, bone age ≤ 16 years
OR
Diagnosis of growth hormone deficiency caused by gene deletion
Clinical documentation showing either growth velocity ≥ 2 SD below the mean OR height ≥ 2.25 SD below the mean
Subnormal response (< 10 ng/mL) to two of the following growth hormone stimulation tests: arginine, clonidine, glucagon, insulin, levodopa, or propranolol
Development of neutralizing antibodies to growth hormone product(s)
Bone age limits: if female, bone age ≤ 14 years; if male, bone age ≤ 16 years

Clinical documentation showing growth velocity of at least 2 cm/year
For males: chronological age > 16 years and bone age ≤ 16 years OR chronological age ≤ 16 years
For females: chronological age > 14 years and bone age ≤ 14 years OR chronological age ≤ 14 years

12 months