Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Short Stature. 
Treatment:  Norditropin Flexpro 15mg/1.5ml Pen Injector To Inject 1.7mg Subcutaneously. 

The insurer denied the  Norditropin Flexpro 15mg/1.5ml Pen Injector To Inject 1.7mg Subcutaneously. 

The denial is upheld. 

The patient is a male diagnosed with GHD (growth hormone deficiency). This request is for Norditropin. As reported, he has been on GH (growth hormone) therapy (1.7 mg [milligrams] seven days a week). His GH (growth hormone) stimulation test with arginine and clonidine peaked at 7.25. 

His pretreatment IGF1 (insulin-like growth factor 1) was 265 (83-519); Z-score was + [plus] 0.4 SD [standard deviations]; IGFBP3 (insulin-like growth factor binding protein 3) was 4.2. His MRI (magnetic resonance imaging) was normal. 

The patient's pretreatment height was 143.51 cm (centimeters) (-0.79 SDS [standard deviation score]) and was 155.29 cm (centimeters) (-1.47 SDS [standard deviation score]) with height velocity over 2 years 6 months of 4.7 cm/year (centimeters per year). 

The patient's height most recently was 158.597 cm (centimeters) (-1.42 SDS [standard deviation score]). 

The patient's mother's height is 165.1 cm (centimeters), and father's height is 165.1 cm (centimeters)/ His mid-parental height is 171.6 cm (centimeters) (-0.73 SDS [standard deviation score]). 

No, the treatment with Norditropin is not medically necessary. 

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

Classic GH (growth hormone) deficiency -
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; 
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). 

The patient did not meet height and height velocity criteria, as his pretreatment height and height velocity are normal. GH (growth hormone) stimulation testing peaked at less than 10 ng/ml (nanograms per milliliter).  His IGF-I (insulin-like growth factor 1) was normal. The pediatric endocrine society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing. 

Idiopathic Short stature - 
Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines (4-9). FDA (Food and Drug Administration) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS (standard deviation score) 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." 

The patient does not have a pretreatment height less than or equal to -2.25 SD (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. 

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient, as the request is not medically necessary as described above.