Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Short Stature
Treatment: Genotropin
The insurer denied: Genotropin
The denial is upheld.

The patient is an adolescent male diagnosed with Idiopathic Short Stature. This request is for Genotropin. His GH (growth hormone) stimulation test with arginine and clonidine peaked at 18.2. His MRI (magnetic resonance imaging) was normal. The patient's weight was 62.80. His height was 130 centimeters (-1.68 SDS [standard deviation score]). The patient's mid-parental height is 173.355 centimeters (-0.49 SDS [standard deviation score]). 

The requested Genotropin is not medically necessary. 

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

Classic GH (growth hormone) deficiency.
Classic GH (growth hormone) deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH (growth hormone) deficiency published by the GH (growth hormone) research society (1), the Lawson Wilkins Pediatric Endocrinology Society (2, 3), and the medical guidelines for GH (growth hormone) 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 SD (standard deviation) below the mean; 
2) Height of more than 1.5 SD (standard deviation) below the midparental height; 
3) Height of more than 2 SD (standard deviation) below the mean, and a height velocity over one year of more than 1 SD (standard deviation) below the mean for chronological age, or a decrease in height SD (standard deviation) 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 SD (standard deviation) below the mean over one year, or more than 1.5 SD (standard deviation) sustained over two years. 
The biochemical criteria include low IGF1 (insulin-like growth factor 1) or IGFBP3 (insulin-like growth factor binding protein 3) or GH (growth hormone) stimulation testing, with a peak GH (growth hormone) of less than 10 ng/ml (nanograms per milliliter). 

The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10. 

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 (United States Food and Drug Administration) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS [standard deviation score] 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."[10-13]

The patient does not have a pretreatment height less than or equal to -2.25 SD (standard deviation). 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.