Increlex — United Healthcare

Growth Hormone Gene Deletion

Initial criteria

Submission of medical records documenting all of the following: diagnosis of severe primary IGF-1 deficiency (PIGFD); documentation of height below -3.0 SD mean for age and gender; documentation of IGF-1 below -3.0 SD mean for age and gender; documentation of growth charts for length/height and weight for age and gender with evidence of growth velocity deceleration over time; calculated growth velocity
One of the following: patient is unresponsive to a trial of growth hormone therapy OR documentation of one of the following: very low or undetectable level of GHBP, very low or undetectable level of GHR mutations known to cause Laron syndrome/GH insensitivity syndrome, GH1 gene deletion (GHD type 1A), GH-neutralizing antibodies, STT5b gene mutation, IGF-1 gene deletion or mutation
Other causes of low IGF-I levels have been ruled out (e.g., growth hormone deficiency, undernutrition, hepatic disease)
Patient will not be treated with concurrent growth hormone therapy
Prescribed by an endocrinologist

Submission of medical records documenting a height increase of at least 2 cm/year over the previous year of treatment as confirmed by all of the following: previous length/height and date obtained, current length/height and date obtained, calculated growth velocity, growth chart for height for age and gender
Submission of medical records documenting both of the following: expected adult height not obtained, expected adult height goal
Patient is not treated with concurrent growth hormone therapy
Prescribed by an endocrinologist

12 months