Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth hormone deficiency
Treatment: Norditropin
The insurer denied Norditropin.
The denial is upheld.

This is a female child diagnosed with growth hormone deficiency (GHD). This request is for Norditropin 1.5 milligrams per week / 0.3 milligrams per kilograms per week. As reported; the patient experienced an adverse reaction of Genotropin (local pain/ burning painful). She is autistic. Her growth hormone stimulation test with glucagon and clonidine peaked at 4.0 and 5.1 respectively. Her breasts and pubic hair were at tanner-one. Her magnetic resonance image was normal.  The patient was started on Genotropin.  The patient's insulin like growth factor one was 134 (58-367); her Z-score was -0.5 standard deviations (SD).

The patient's weight was 31.8 kilograms. The patient's mother's height is 149.225 centimeters and father's height is 170.18 centimeters and mid parental height is 153.2 centimeters (-1.56 standard deviation scores).

No, the proposed treatment with Norditropin is not medically necessary.
The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below.

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 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 3.0 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 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 2.0 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 hormone factor one or insulin-like growth factor binding protein three or growth hormone stimulation testing with a peak GH less than 10.0 nanograms per milliliter.

This patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. Growth hormone stimulation testing peaked at less than ten nanograms per milliliter.

The Pediatric Endocrine Society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing.

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 standard deviation (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]

This patient does not have a pretreatment height 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.