Increlex

Patient is 2 to 18 years of age; AND 

Patient is at least 2 years of age at the time of treatment initiation; AND 

Epiphyseal growth plates have not closed; AND 

SPIGFD diagnosis is confirmed as defined by
a) having a known genetic mutation that causes SPIGFD (e.g., mutations in the GH receptor (GHR) gene/Laron’s syndrome, post-GHR signaling pathway, and IGF-1 gene defects) (See Note 1)
AND/OR
b) having clinical and biochemical features of SPIGFD:
i) height standard deviation score ≤ –3.0 AND
ii) basal IGF-1 levels below the 2.5th percentile for age and gender AND
iii) GH sufficiency (i.e., patient is not GH deficient; random or stimulated GH level of > 10 ng/mL and failure to increase IGF-1 by 50 ng/mL in response to exogenous GH during an IGF-1 generation test)
iv) exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

AND

Patient is under the care of, or in consultation with a pediatric endocrinologist; AND

Mecasermin is not being used in combination with recombinant growth hormone (GH) treatment.