Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature
Treatment: Humatrope Injection 
The insurer denied the Humatrope Injection.
The denial is upheld. 

The patient is a male. This request is for Humatrope. 

The patient started GH (growth hormone) therapy earlier this year. His GH (growth hormone) stimulation test several months prior to starting therapy revealed glucagon and L-dopa peaked at 12 and 3.5 respectively. His height velocity is reported to be 3 cm/yr (centimeters per year). 

Two months after starting growth hormone therapy, the patient's testes are 10-12 cc (cubic centimeter) bilaterally and pubic hair is at tanner 2-3. Prior to therapy, his IGF1 (insulin-like growth factor 1) was 182 (139-533), and his IGFBP3 (insulin-like growth factor binding protein 3) was 3654. 

The patient's height on therapy two months after starting GH (growth hormone) was 147.40 cm (centimeters) (-1.74 SDS [standard deviation score]). His pretreatment height two years prior was 134.01 cm (centimeters) (-1.58 SDS [standard deviation score]). Five months prior, his pretreatment height was 147.396 cm (centimeters) (-1.23 SDS [standard deviation score]), with height velocity over one year nine months of 7.4 cm/yr (centimeters per year).
 
The patient's mother's height is 156.21 cm (centimeters), and his father's height is 172.72 cm (centimeters). The mid-parental height is 170.965 cm (centimeters) (-0.82 SDS [standard deviation score]). 

No, the treatment with Humatrope Injection 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, 5, 6, 7, 8, 9). FDA (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."

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