Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth hormone deficiency (GHD)

Treatment: Norditropin injection 10 milligrams (mg)/ 1.5 milliliter (ml), quantity of 6 every 30 days

The insurer denied coverage for Norditropin injection 10 mg/ 1.5 ml, quantity of 6 every 30 days.  The denial is upheld.

This is a male with a history of growth hormone deficiency (GHD). The patient was seen by Pediatric Endocrinologist for a follow up for GHD. Height was in the 12th percentile. Mid parental height (MPH) was 68 inches. Recent growth hormone (GH) peak on a stimulation test was 9.9 nanograms (ng)/ deciliter (dl). The treating physician recommended treatment with Norditropin.

His bone age was 4 months less than his chronological age (CA) on the most recent labs; prior bone age revealed 11 months less than his CA. Prior labs showed his insulin-like growth factor-1 (IGF-1) was 325 and a recent value noted his IGF1 was 356. Magnetic resonance imaging (MRI) of the brain showed no evidence of a pituitary lesion. He was at Tanner 4-5, with a weight of 54.52 kilograms (kg).  

His height was 151.13 centimeters (cm) [-1.44 standard deviation score (SDS)] and almost two years later was 161 cm (-1.40 SDS) with height velocity over 1.6 years of 6.2 cm/year. His MPH is 173 cm (-0.54 SDS).

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 standard deviations (SD) 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 more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year in children over 2 year of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 year or more than 1.5 SD sustained over 2 years. The biochemical criteria include low IGF1 or insulin-like growth factor binding protein 3 (IGFBP-3) or GH stimulation testing with a peak GH less than 10ng/ml.

The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. GH stimulation testing peaked at less than 10ng/ml.

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 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]

The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet ISS criteria. The request 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.

The insurer's denial of coverage for Norditropin injection 10 mg/ 1.5 ml, quantity of 6 every 30 days is upheld. Medical Necessity is not substantiated.