Appeal type: Medical necessity
Decision: Upheld

Diagnosis: GHD (growth hormone deficiency) 
Treatment: Nutropin AQ Nuspin 10 

The insurer denied the Nutropin AQ Nuspin 10. The denial is upheld. 

No, the treatment with Nutropin AQ Nuspin 10 is not medically necessary.

The patient is a female diagnosed with GHD (growth hormone deficiency). This is request is for Nutropin. She started GH (growth hormone) and her height velocity is reported to be 3 cm/year. 

The patient's mid-parental target height is reported to be 64 inches, 162.56 cm, -0.12 SD. Pre-treatment height was 1.29 SD below target height SD. Predicted adult height is normal at -1.52 SD or 6th percentile. No other information was provided. 

The peer-reviewed literature, including consensus clinical guidelines and randomized controlled trials, are summarized as follows: Classic GH 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 SD below the mean; 2) Height of more than 1.5 SD below the midparental height; 3) Height of more than 2 SD below the mean, and a height velocity over one year of more than 1 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 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 or GH stimulation testing, with a peak GH of less than 10ng/ml. 
		
The patient did not meet auxological criteria, as pretreatment height and height velocity are normal. Height prediction was also normal. GH stimulation testing peaked at less than 10ng/ml. 

The pediatric endocrine society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing. 

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 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.