Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature
Treatment: Norditropin Injection 10/1.5ML (milliliter)
The insurer denied: Norditropin Injection 10/1.5ML (milliliter)
The denial is upheld

This is an adolescent female diagnosed with idiopathic short stature (ISS). This request is for Norditropin. 

The patient's growth hormone (GH) stimulation this past summer with arginine and glucagon peaked at 20. The patient's bone age on earlier this year was ten years at chronological age (CA) ten years eight months. The patient's insulin-like growth factor one (IGF1) was 151; insulin-like growth factor binding protein three (IGFBP3) was 4.01. Three months previously, the patient's insulin-like growth factor one (IGF1) was 131; insulin-like growth factor binding protein three (IGFBP3) was 4.4. The patient's pubic hair was at tanner-one.  The patient's weight was 27.5 kilograms (kg).  Her height at 9.67 years old was 121.9 centimeters (cm) (-[minus] 2.33 standard deviations [SDS]) and at 10.67 years old was 129.5 centimeters (-1.80 standard deviations) with height velocity over one year of 7.6 centimeters per year.  The patient's mid parental height is 166.2 centimeters (+[plus]0.44 standard deviations).

The proposed treatment is not medically necessary.

The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:
Classic Growth Hormone Deficiency
Classic growth hormone deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of growth hormone deficiency published by the GH Research Society [1], the Lawson Wilkins Pediatric Endocrinology Society [2, 3], and the medical guidelines for 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 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 3.0 standard deviations below the mean; 2) height more than 1.5 standard deviations below the mid parental height standard deviation; 3) height more than 2.0 standard deviations below the mean and a height velocity over one year more than 1.0 standard deviations below the mean for chronological age, or a decrease in height standard deviations 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 more than 2.0 standard deviations below the mean over one year or more than 1.5 SD sustained over two years. The biochemical criteria include low insulin-like growth factor one (IGF1) or insulin-like growth factor binding protein (IGFBP3) or growth hormone stimulation testing with a peak growth hormone less than ten nanograms per milliliter (ng/mL).

The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than ten. 

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." [10-13]

The patient's most recent pretreatment height is not less than or equal to -2.25 standard deviations. 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.