Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature
Treatment: Nutropin AQ Nuspin 
The insurer denied the Nutropin AQ Nuspin.
The determination is overturned.


The patient was diagnosed with idiopathic short stature (ISS). His growth hormone (GH) stimulation test with arginine and clonidine peaked at 14.1. His height velocity is reported to be 4.35 centimeters per year (cm/yr). His testes were at Tanner 4. His Insulin-like Growth Factor 1 (IGF1) was 176 (range 29-424 ).

His height was 129 cm (-2.96 standard deviation score (SDS)) and then 132.7 cm (-3.00 SDS) with height velocity of 4.6 cm/yr. His mother's height is 152.4 cm and father's height is 167.64 cm and mid parental height is 166.52 cm (-1.44 SDS).

The medical necessity of the Nutropin AQ Nuspin is under review. 

The Nutropin AQ Nuspin is medically necessary for this patient.

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

Classic GH deficiency:

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, 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 IGF1 or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 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]. 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 -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."

This patient had a pretreatment height less than or equal to -2.25 SD. The patient's height velocity and bone age would not allow the patient to reach a normal adult height. The request therefore meets idiopathic short stature criteria. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.