Increlex (mecasermin) — Highmark

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

Reauthorization criteria

• 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

Approval duration

12 months