Diagnosis: Idiopathic Short Stature (ISS).
Treatment: Norditropin 10 milligrams (MG) /1.5 milliliters (mL).

The insurer denied the Norditropin 10 milligrams (MG) /1.5 milliliters (mL). The denial is overturned.

This patient is a female diagnosed with idiopathic short stature (ISS). This request is for Norditropin.

The patient is on growth hormone (GH) therapy Norditropin; her height velocity has increased from 2.73 centimeters per year (cm/yr) to 7.7 cm/yr. The patient's insulin-like growth factor one (IGF1) was 87 (67-349). Her pretreatment height was 108 centimeters (cm) (-3.38 standard deviations [SDS]) and was 111.7 cm (-3.72 SDS with height velocity over one year four months of 2.7 cm/yr. The patient's height on therapy after a year was 120.2 cm (-2.91 SDS). The patient's mother's height is 158.4 cm and father's height is 171.3 cm and mid parental is 158.35 cm (-0.77 SDS).

Yes, the proposed Norditropin is medically necessary.

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

Classic growth hormone (GH) deficiency:
Classic growth hormone (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 3.0 standard deviations (SD) below the mean; 2) height more than 1.5 SD below the mid parental height SD; 3) height more than 2.0 SD below the mean and a height velocity over one year more than 1.0 SD below the mean for chronological age, or a decrease in height SD 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 SD below the mean over one year or more than 1.5 SD sustained over two years. The biochemical criteria include low insulin-like growth factor one (IGF1) or insulin-like growth factor binding protein three (IGFBP3) or GH stimulation testing with a peak GH less than ten nanograms per milliliter (ng/mL)

The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported and the IGF1 was 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]. 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."

The patient had a pretreatment height less than or equal to -2.25 SD. The patient's height velocity and bone age would not allow the patient to reach a normal adult height. The request therefore meets idiopathic short stature criteria.

The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.