Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature
Treatment: Nutropin AQ Nuspin 20
The Nutropin AQ Nuspin 20 is not medically necessary.

The patient is a female diagnosed with ISS (idiopathic short stature) and delayed puberty. This request is for Nutropin. As reported in the provided records, she was treated with a Supprelin for CPP (central precocious puberty); stopped two years ago. Her bone age was 13 years at CA (chronological age) 12 years four months. It was 12 years six months - 13 years at CA 12 years one month. It was 12 years six months-13 years at CA 11 years ten months. It was 12 years six months - 13 years at CA 11 years eight months. 

The patient's pubic hair started at age ten. Her IGF1 (insulin like growth factor one) was 246. Her breasts are ~ six to eight cm (centimeters) bilaterally with tanner two to three and pubic hair is at tanner three. Her height at 11.67 y/o (years old) was 141.6 cm (-1.00 SDS). At 12.33 years old it was 145.3 cm (-1.08 SDS), with a height velocity over nine months of 5.6 cm/year. Her mother's height is 162.56 cm. Her father's height is 172.72 cm. Mid-parental height is 161.14 cm (-0.34 SDS). 

The peer-reviewed literature, including consensus clinical guidelines and randomized controlled trials, are summarized below:

Classic GH (growth hormone) deficiency
Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH deficiency published by the GH research society (1), the Lawson Wilkins Pediatric Endocrinology Society (2, 3), and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists (4). The above-referenced guidelines are the latest available guidelines from these respective societies. The diagnosis is based on auxological, biochemical and sometimes radiological findings. 

The auxological criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are 
1)	Severe short stature, defined as a height of more than 3.0 SD below the mean; 
2)	Height of more than 1.5 SD below the midparental height; 
3)	Height of more than 2.0 SD below the mean, and a height velocity over one year of more than 1.0 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over one year in children over two years of age; 
4)	In the absence of short stature, a height velocity of more than 2.0 SD below the mean over one year, or more than 1.5 SD sustained over two years. 

The biochemical criteria include low IGF1 or IGFBP3 (insulin-like growth factor binding protein three) or GH stimulation testing, with a peak GH of less than ten nanograms per milliliter (ng/ml). 
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported.

Idiopathic Short stature
Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines (4-9). FDA approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means."

The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet idiopathic short stature criteria. 

The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.