Appeal type: Medical necessity
Decision: Upheld


Diagnosis: Idiopathic short stature.
Treatment: Nutropin absorptive quotient (AQ) Nuspin 10.
The insurer denied: Nutropin absorptive quotient (AQ) Nuspin 10.
The denial is: Upheld.

The patient is a male diagnosed with idiopathic short stature (ISS). This request is for Nutropin 1.0 milligrams (mg) daily. His growth hormone (GH) stimulation test peaked at 13. His testes and pubic hair were at tanner 1. He has attention deficit hyperactivity disorder (ADHD). The subject under review is the medical necessity for Nutropin absorptive quotient (AQ) Nuspin 10.

The requested treatment is not medically necessary. The peer-reviewed literature including consensus clinical guidelines and randomized controlled trials is summarized below.
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 height, height velocity, and 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 deviations (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 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 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/milliliter (ng/ml). 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]. 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 the 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.