Diagnosis: Idiopathic short stature
Treatment: Humatrope 72-unit cartridge (two every 30 days) (Pre-Service)
The insurer denied the Humatrope 72-unit cartridge (two every 30 days) (PreService).
The denial is upheld.

This patient is a female diagnosed with idiopathic short stature (ISS). This request
is for Humatrope. The patient is on growth hormone (GH) therapy per chart. Her GH
stimulation test on with glucagon and L-dopa peaked at 12.

No, the proposed treatment with Humatrope 72 unit cartridge (two every 30 days) is
not medically necessary.

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 3.0 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 IGF1 or 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 peaked at greater than ten.

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]. 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 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.