Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature

Treatment: Nutropin AQ 10 milligram (mg)/2 milliliter (ml), (4ml per month)

The insurer denied coverage for Nutropin AQ 10 milligram (mg)/2 milliliter (ml), (4ml per month)

The denial is upheld.

 
This is a child diagnosed with idiopathic short stature (ISS). This request is for Nutropin 1 mg daily. His growth hormone (GH) stimulation test with clonidine and arginine peaked at 13.3. His height velocity is reported to be 3.84 centimeters per year (cm/yr). His insulin-like growth factor 1 (IGF1) was 172 (37-459); Z-score was 0; insulin-like growth factor binding protein 3 (IGFBP3) was 5010 (1828-6592). 

His weight was 34.4 kilograms (kg). His height was 129.5 cm (-2.08 SDS) with a height velocity over 7 months of 5.7 cm/yr. His mother's height is 152.40 cm and father's height is 167.64 cm and mid parental height is 166.52 cm (-1.44 SDS). 

The health plan acted reasonably and with sound medical judgment and in the best interest of the patient as the request is not medically necessary as described below. The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:

Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH deficiency published by the GH research society, the Lawson Wilkins Pediatric Endocrinology Society, and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists. 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 Deviation (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 (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 years 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 years. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10 nanograms per milliliter (ng/ml). The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10. 

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials (RCT) and consensus guidelines [4-9]. Food & Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SD 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 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.

The health plan acted reasonably, with sound medical judgment and in the best interest of the patient.

The insurer's denial of coverage for the Nutropin; Nutropin AQ 10 milligram (mg)/2 milliliter (ml), (4ml per month) is upheld. Medical necessity is not substantiated.