Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Short Stature. 
Treatment: Norditropin Flexpro 15mg (milligrams)/1.5ml (milliliters)/ pen injector 1.8mg injected subcutaneously once daily for 1 year. 

The insurer denied the Norditropin Flexpro 15mg/1.5ml/ pen injector 1.8mg injected subcutaneously once daily for 1 year.  The denial is overturned. 

The patient is a female diagnosed with GHD (growth hormone deficiency). This request is for Norditropin. 

The patient's GH (growth hormone) stimulation test with clonidine and arginine peaked at 4.15. Her MRI (magnetic resonance image) was normal.  Her IGF1 (insulin-like growth factor 1) was 213. A few months later, her IGF1 (insulin-like growth factor 1) was 255 (90-581); Z-score was +0.2 SD (standard deviations). 

The patient's height was 134.874 cm (centimeters) (-0.56 SDS [standard deviation score]). Approximately 2 years later, it was 145.896 cm (centimeters) (-1.44 SDS [standard deviation score]). This was a height velocity over two years four months of 4.1 centimeters per year. 

The patient's mother's height is 162.56 cm (centimeters). The patient's father's height is 165.1 cm (centimeters). The mid-parental height is 157.33 cm (centimeters) (-0.93 SDS [standard deviation score]). 

Yes, the treatment with Norditropin Flexpro is medically necessary. 

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

Classic GH (growth hormone) deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH (growth hormone) deficiency published by the GH (growth hormone) 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 auxological, biochemical and sometimes radiological findings. 

The auxological criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are: 1) Severe short stature, defined as a height of more than 3 SD (standard deviation) below the mean; 2) Height of more than 1.5 SD (standard deviation) below the midparental height; 3) Height of more than 2 SD (standard deviation) below the mean, and a height velocity over one year of more than 1 SD (standard deviation) below the mean for chronological age, or a decrease in height SD (standard deviation) of more than 0.5 over one year in children over two years of age; or 4) In the absence of short stature, a height velocity of more than 2 SD (standard deviation) below the mean over one year, or more than 1.5 SD (standard deviation) sustained over two years. 

The biochemical criteria include low IGF1 (insulin-like growth factor 1) or IGFBP3 (insulin-like growth factor binding protein 3) or GH (growth hormone) stimulation testing, with a peak GH (growth hormone) of less than 10 ng/ml (nanograms per milliliter). 

This patient met biochemical criteria. Her GH (growth hormone) stimulation testing peaked at less than 10ng/ml (nanograms per milliliter). The patient met height criterion 4, as her height velocity is more than 1.5 SD (standard deviations) below the mean over more than two years. The patient met both height and height velocity and biochemical criteria for the diagnosis of GH (growth hormone) deficiency. GH (growth hormone) in the treatment of GH (growth hormone) deficiency is medically necessary.