Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature
Treatment: Humatrope (Somatropin) 72-unit cartridge, quantity of three every 30 days

The insurer denied coverage for Humatrope (Somatropin) 72-unit cartridge, quantity of three every 30 days.
The denial is upheld. 

This is a female patient diagnosed with Idiopathic short stature (ISS). She was seen by a pediatric endocrinologist for complaints of poor growth and weight gain. A request was made for Humatrope. The patient's height velocity is reported to be 5.3 centimeters (cm) per year.  The patient's magnetic resonance imaging (MRI) was normal. The patient's mother's height was 152.4 cm and father's height was 172.72 cm making the patient's mid-parental height of 156.06 cm. The height prediction was 155.3 cm.

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, the Lawson Wilkins Pediatric Endocrinology Society, and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists. 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 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 a certain 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-growth factor (IGF) 1 or IGF-binding protein 3 or GH stimulation testing with a peak GH less than 10 nanograms per milliliter (ng/mL). In this case, the patient did not meet biochemical criteria. GH stimulation testing is not reported. 

GH in the treatment of ISS is supported by randomized controlled trials and consensus guidelines. Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height standard deviation score (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." In this case, the patient had a pretreatment height less than or equal to -2.25 standard deviation (SD). The patient's height velocity and bone age would allow the patient to reach a normal adult height. 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 plan acted reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Humatrope (Somatropin) 72-unit cartridge, quantity of three every 30 days should be upheld. The medical necessity is not substantiated.