Diagnosis: Idiopathic Short Stature (ISS)

Treatment growth hormone Humatrope (somatropin) 12 mg (milligrams) injections

The insurer denied coverage for growth hormone Humatrope (somatropin) 12 mg injections

The denial is upheld

This is the case of a female diagnosed with idiopathic short stature (ISS). This request is for Humatrope. As reported; she started growth hormone (GH) therapy in. Her GH stimulation test, she peaked at 11.9. Her bone age was young adolescence at chronological age (CA); her insulin-like growth factor 1 (IGF1) was 219 (152-593 page 10); Z (standard score)-score was -1.0 standard deviation (SD). Her breasts were at Tanner 3. Her weight on was 38.46 kilograms (kg).

Her pretreatment height at young adolescence was 140 centimeters (cm) (-1.05 SD) and 144.907 cm (-1.36 SD) with height velocity over 1 year of 4.8 cm/year (centimeter per year).

Her height on therapy progress was 149.9 cm (-1.13 SD). Her mother's height is 163.83 cm and father's height is 171.45 cm and mid parental height is 161.14 cm (-0.34 SD).

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

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 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 or insulin-like growth factor binding protein-3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms/milliliters (ng/ml).

The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10.

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

The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet ISS criteria.

The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.

The insurer's denial of coverage for growth hormone Humatrope (somatropin) 12 milligrams (mg) injections is upheld. Medical necessity is not substantiated