Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Idiopathic Short Stature.
Treatment:  Genotropin.

The insurer denied Genotropin.  The denial is upheld.

The patient is a teenage male diagnosed with Idiopathic Short Stature. This request is for Genotropin. The patient's GH (growth hormone) stimulation test four months ago with arginine and clonidine peaked at 16.7. His MRI (magnetic resonance imaging) was normal. His bone age eight months ago was 12 years 6 months, which is less than his CA (chronological age). Five years ago, his IGF1 (insulin-like growth factor 1) was 102; IGFBP3 (insulin-like growth factor binding protein 3) was 3446. Eight months ago, his testes were 10-12 ml (milliliters) at right and 12 to 15 ml (milliliters) at left, and pubic hair was at tanner 2. His height velocity is reported to be 4.4 centimeters per year. His weight was 73.60 pounds. The patient's height was previously 139.7 centimeters (-1.52 SDS [standard deviation score]), and eight months ago it was 144.4 centimeters (-1.90 SDS [standard deviation score]) with height velocity over 1.210 year of 3.9 centimeters per year. His 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 (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. Therefore, the request is not medically necessary.