Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Short Stature (growth failure).
Treatment: Norditropin Flexpro.
The insurer denied: Norditropin Flexpro.
The denial is upheld.

The patient is an adolescent male diagnosed with ISS (idiopathic short stature). This request is for Norditropin. As reported, he also has ADHD (attention deficit hyperactivity disorder). Per the encounter note, the start date of Norditropin was this past summer. His GH (growth hormone) stimulation test peaked at 13. His bone age at CA (chronological age) 11 years six months was 12 years six months. His pubic hair and testes were noted at tanner 1. His weight was 35.30 kg (kilograms). His height at 10.32 years old was 131.4 cm (centimeters), which is - (minus) 1.31 SDS (standard deviation score). At 11.65 years old, it was 134.5 cm (centimeters), which is - (minus) 1.74 SDS (standard deviation score). His height velocity over three months was 2.3 centimeters per year. His mid parental height is 163.3 cm (centimeters), which is - (minus) 1.89 SDS (standard deviation score).

The requested Norditropin is not medically necessary.

The peer-reviewed literature, including consensus clinical guidelines and randomized controlled trials, is summarized below:
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 mid-parental 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.

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 - (minus) 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 - (minus) 2.25 SD (standard deviations). The patient, therefore, does not meet the idiopathic short stature criteria.

The request does not meet any nationally accepted criteria for use of growth hormones. Therefore, the request is not medically necessary.