Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth Hormone Deficiency (GHD)

Treatment: Norditropin 15 milligrams /1.5 milliliter (15 mg/1.5 ml) pen injector

The insurer denied coverage for Norditropin 15 milligrams /1.5 milliliter (15 mg/1.5 ml) pen injector.

The denial is upheld.

This child had a history of short status, juvenile idiopathic arthritis (JIA), hypothyroidism, and attention deficit hyperactivity disorder (ADHD). Pediatric Endocrinologist's office notes indicate annualized growth velocity is stabilized at 5.3 centimeters per year (cm/yr). He had a growth deceleration from 10% (percent) to 5% and a weight deceleration from 13% to 5%. Short-stature homeobox gene (SHOX) genetic testing was negative. Bone ages have been one year delayed compared with his chronological age. Mid-parental height (MPH) is 69 inches and the patient is 65.8 inches. The physician recommended administering Norditropin 15 milligrams/ 1.5 milliliter (15 mg/1.5 ml) to treat short stature.   

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

Classic GH [growth hormone] deficiency
Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH 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 SD [standard deviation] below the mean; 2) height more than 1.5 SD below the mid parental height SD; 3) height more than 2 SD below the mean and a height velocity over 1 year [yr] more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 yr in children over 2 yr of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 yr or more than 1.5 SD sustained over 2 yr. The biochemical criteria include low IGF1 [insulin like growth factor] or IGFBP3 [Insulin Like Growth Factor Binding Protein 3] or GH stimulation testing with a peak GH less than 10.
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10. IGF-I was normal.

The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. 

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]. 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. The patient therefore does not meet idiopathic short stature criteria. 

The patient does not meet any nationally accepted criteria for use of growth hormone. The health plan acted reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for the Norditropin 15 milligrams /1.5 milliliter (15 mg/1.5 ml) pen injector to treat Growth Hormone Deficiency (GHD) is not substantiated. The insurer's denial is upheld.