Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature
Treatment: Omnitrope (Somatropin) 0.29 milligrams (mg)/kilograms (kg) per week.
The insurer denied the request for Omnitrope (Somatropin) 0.29 milligrams (mg)/kilograms (kg) per week.
The health plan's determination is upheld.

The patient is a male who is diagnosed with idiopathic short stature (ISS). This request is for Omnitrope 1.9 mg daily. As reported, he was started on Humatrope. He is taking 1.8 mg daily.
His growth hormone (GH) stimulation with Arginine and Clonidine peaked. His magnetic resonance imaging (MRI) was normal. His height velocity is reported to have improved from 4.6 centimeters per year (cm/yr) to 10.6 cm/yr. 

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

The requested health service/treatment of Omnitrope (Somatropin) 0.29 milligrams mg/kg per week is not medically necessary.
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 (standard deviation) below the mid parental height SD (standard deviation); 3) height more than 2 SD (standard deviation) below the mean and a height velocity over 1 year more than 1 SD (standard deviation) below the mean for chronological age, or a decrease in height SD (standard deviation) of more than 0.5 over 1 year 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 year or more than 1.5 SD sustained over 2 years. The biochemical criteria include low Insulin-like Growth Factor 1 (IGF1) or Insulin-like growth factor binding protein 3 (IGFBP3) or GH (growth hormone) stimulation testing with a peak GH less than 10 nanograms/milliliter (ng/ml).
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10.

Idiopathic Short stature:
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 (standard deviation score) less than or equal to minus (-)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 (standard deviation). The patient therefore does not meet idiopathic short stature criteria.
The request does not meet any nationally accepted criteria for use of the requested growth hormone. The request is therefore not medically necessary.

The health plan's determination of medical necessity is upheld in whole.