Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth failure
Treatment: Nutropin AQ
The insurer denied the Nutropin AQ.
The health plan's determination is upheld.

The patient is an adolescent male who is seeking growth hormone (GH) treatment for growth failure. His mother's height is 64 inches, and his father's height is 65 inches giving him mid parental height of 67 plus or minus (+/-) 2 inches. He was initially evaluated in the pediatric endocrinology clinic last year. At that time, his height was 148.3 cm (4.39 percentile: -1.71 standard deviation (SD)), and his weight was 60.6 kilograms (kg) (83 percentile: +0.9 SD). 

At a follow up visit, his height was 151.2 centimeters (cm) (2.27 percentile:-2.00 SD) while his weight was 64.5 kg. His bone age was read as 14 years 6 months at chronological age 14 years 7 months. He had normal insulin-like growth factor binding protein-3 (IGFBP-3). He underwent GH stimulation testing, and his peak GH response was 13.1 nanograms/milliliter (ng/ml) after arginine and clonidine. His other evaluation, at that time, showed normal Insulin-like growth factor 1 (IGF-1) and IGFBP-3. His height at that time was 152.2 cm (2.29 percentile: -2.00 SD).

At issue is the medical necessity for Nutropin AQ.
I uphold the health plan's determination, in whole. 

Nutropin AQ is not medically necessary.

The Food and Drug Administration (FDA) approved indications for GH treatment include growth failure due to growth hormone deficiency (GHD), short stature in children born small for gestational age without catch-up growth by age 2 to 4 years, short stature associated with Noonan syndrome, and idiopathic short stature (defined as height standard deviation score (SDS) less than or equal to (<=) -2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range). Diagnosis of GHD involves clinical history (with primary consideration given to genetic background, degree of short stature and growth velocity), physical examination, auxologic data, bone age and measurement of insulin-like growth factor I (IGF-I) and IGF binding protein 3 (IGFBP-3), provocative GH testing, and magnetic resonance imaging (MRI) of the pituitary. Growth velocity and the degree of short stature are primary considerations in the decision to pursue evaluation for GHD. Height more than 2 SD below the mean, height more than 1.5 SD below the mid-parental height, height velocity more than 2 SD below the mean for chronological age over 1 year, or a decrease in height SD of more than 0.5 over 1 year are all auxologic criteria considered for the evaluation of GHD.

This patient is quite short for his age; however, he is not from tall parents, and his mid parental height (+/-1 SD) is 67+/-2 inches. At the time of his initial evaluation, his height was 1.71 SD below the mean for his age and 0.78 SD below his mid parental height. At a follow up visit, he had grown at a rate of 3.6 cm per year in 9.5 months, and his height had dropped to 2.27 percentile (-2.0 SD). Although this patient's height was 2.0 SD below the mean for age, his IGF-1 and IGFBP-3 were normal, and his peak GH response was 13.1 ng/ml after stimulation arguing against GHD. Although this patient's growth velocity was less than expected, he was early pubertal (Tanner II-III) at the age of 14.6 years which is later than an average boy and slow growth can be explained by late puberty as at this age growth not only depends on GH but also on testosterone. Growth velocity in boys increases late in puberty and growth spurt occurs late in Tanner stage IV. Even though this patient's height prediction based on his bone age was 63.8 inches which is on the lower side, as his current height is not 2.25 SD below the mean for age, he does not qualify for GH treatment under idiopathic short stature indication. This patient has grown 1.0 cm in 2.3 months which gives him a growth velocity of 5.2 cm per year.