Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature (ISS).

Treatment: Norditropin FlexPro 15milligrams/1.5 milliliters pen injector to inject 1.6 milligrams subcutaneously once daily for one year for diagnosis code R62.52 [short stature, child]. 

The insurer denied coverage for Norditropin FlexPro 15milligrams/1.5 milliliters pen injector to inject 1.6 milligrams subcutaneously once daily for one year for diagnosis code R62.52.

The denial is upheld. 

This patient is a male child who was diagnosed with Idiopathic Short Stature (ISS). This request is for Norditropin. He has been receiving Growth Hormone (GH) therapy. His pretreatment height velocity is reported to be 5.5 centimeters (cm)/year. 

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

Classic GH 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 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 [insulin-like growth factor 1] or IGFBP3 [insulin-like growth factor binding protein-3] or GH stimulation testing with a peak GH less than 10ng/ml [nanograms per milliliter].
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported.

Idiopathic Short stature
Growth hormone in the treatment of ISS is supported by randomized controlled trials and consensus guidelines [4, 5, 6, 7, 8, 9]. Food and Drug Administration (FDA) 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 request does not meet any nationally accepted criteria for use of GH. The request is therefore not medically necessary.

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

The carrier's denial of coverage for Norditropin FlexPro 15milligrams/1.5 milliliters pen injector to inject 1.6 milligrams subcutaneously once daily for one year for diagnosis code R62.52 [short stature, child] is upheld. The medical necessity is not substantiated.