Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature
Treatment: Nutropin AQ NuSpin
The insurer denied the Nutropin AQ NuSpin. The health plan's determination is upheld.

This is a young male diagnosed with idiopathic short stature (ISS). As reported, he had attention deficit hyperactivity disorder (ADHD). His height velocity is reported to be 4 centimeters per year (cm/yr). His bone age was 10 years at chronological age (CA) 11 years 1 month. Subsequently, his bone age was 12 years 6 months at CA 12 years 2 months. He is at tanner 1. His Insulin-like growth factor binding protein 3 (IGFBP3) was 3.45, and his Insulin-like Growth Factor 1 (IGF1) was 168.

His height at 11.67 years old was 137.8 centimeters (cm) (-1.32 standard deviation score (SDS)), and at 12.35 years old it was 140.2 cm (-1.52 SDS) with height velocity over 8 months of 3.5 cm/yr (centimeter/year). His mid parental height is 172.9 cm (-0.55 SDS) His predicted adult height is 162.7 cm (-1.97 SDS) The patient had a growth hormone stimulation test with Arginine and Glucagon; the results are not reported.

At issue is the medical necessity for Nutropin AQ NuSpin.
I uphold, in whole, the health plan's determination of medical necessity.

Nutropin AQ NuSpin is not medically necessary.

The peer reviewed literature, including consensus clinical guidelines and randomized controlled trials, are summarized below.

Classic growth hormone (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 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 SD (standard deviation) 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 years 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 IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10 nanograms per milliliter (ng/ml).

The patient does not meet biochemical criteria. Growth hormone stimulation testing is not reported, and the patient's growth factors are normal.

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4-9]. Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height standard deviation score (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."[10-13]

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.