Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth Hormone Deficiency. 
Treatment: Norditropin, Pre-service. 

The insurer denied the Norditropin, Pre-service. 
The denial is overturned. 

This patient is an young male diagnosed with idiopathic short stature (ISS). This request is for Norditropin. 

The patient's growth hormone (GH) stimulation test last year with arginine and clonidine peaked at 10.9 and 8.62 respectively. His height velocity is reported to be 4.5 centimeters per year (cm/yr). Last year, his insulin growth factor one (IGF1) was 101 (50-243).  His height last year was 107.5 centimeters (-2.81 standard deviations [SDS]) and earlier this year was 111.3 centimeters (-2.78 standard deviations [SDS]) with height velocity over seven months of 6.4 centimeters per year.   His mother's height is 152.4 centimeters and father's height is 167.64 centimeters and mid parental height is 166.52 centimeters (-1.44 standard deviations). 

Yes, the proposed Norditropin is 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 GH (growth hormone) deficiency published by the GH 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 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 below the mean; 2) height more than 1.5 standard deviations below the mid parental height standard deviation; 3) height more than 2 standard deviations below the mean and a height velocity over one year more than 1 standard deviations below the mean for chronological age, or a decrease in height 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 more than 2 standard deviations below the mean over one year or more than 1.5 standard deviations sustained over two years. The biochemical criteria include low insulin-like growth factor one (IGF1) or insulin-like growth factor binding protein three (IGFBP3) or growth hormone stimulation testing with a peak GH (growth hormone) less than ten nanograms per milliliter. 

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], [5], [6], [7], [8], [9]. Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS (standard deviations) 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 standard deviations. 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. The request is therefore medically necessary.