Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature
Treatment: Nutropin AQ
The insurer denied Nutropin AQ.
The determination is upheld. 

This is a female patient diagnosed with idiopathic short stature (ISS). Her provider has recommended Nutropin. Her growth hormone (GH) stimulation test with glucagon and levodopa (L-dopa) peaked at 23. Her height velocity is reported to be 3.5 centimeter (cm)/year (yr).  Her mother's height is 160.02 cm and father's height is 190.5 cm and mid parental height is 169.26 cm (plus [+]0.92 SDS).
At issue is the medical necessity of Nutropin aqueous (AQ).

The health plan's determination of medical necessity is upheld in whole.

The requested health service/treatment of Nutropin AQ is not medically necessary for this patient. 
Per the peer reviewed literature including consensus clinical guidelines and randomized controlled trials the requested treatment is not medically necessary.  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) These guidelines are the latest available guidelines from these respective societies. The diagnosis is based on height, height velocity, biochemical and sometimes radiological findings. The height and height velocity criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are 1) severe short stature, defined as a height more than 3 standard deviation (SD) below the mean; 2) height more than 1.5 SD below the mid parental height SD; 3) height more than 2 SD below the mean and a height velocity over 1 year more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year in children over 2 year of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 year or more than 1.5 SD sustained over 2 years. The biochemical criteria include low Insulin-like Growth Factor 1 (IGF1) or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms (ng)/milliliters (ml).
The patient did not meet pretreatment height criterion. GH stimulation testing peaked greater than 10ng/ml. Her GH stimulation test with glucagon and L-dopa peaked at 23. The patient does not meet the growth hormone deficiency criteria.
Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines. (4-9) United States Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS less than or equal to negative [-] 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. The patient does not meet idiopathic short stature criteria.
The request does not meet nationally accepted criteria for use of growth hormone. Therefore, the requested health service/treatment of Nutropin AQ is not medically necessary.