Diagnosis: Idiopathic short stature (ISS)
Treatment: Genotropin
The insurer denied Genotropin.
The health plan's determination is overturned.

This is a female diagnosed with idiopathic short stature (ISS). This request is for Genotropin 12 mg/mL (milligrams/milliliter) Cartridge.

Genotropin 12 mg/mL Cartridge is medically necessary for this patient.

Growth hormone in the treatment of ISS is supported by randomized controlled trials and consensus guidelines. The 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."

This patient had a pretreatment height less than or equal to -2.25 SDS. The patient's height velocity would not allow the patient to reach a normal adult height. The request therefore met idiopathic short stature criteria at the initiation of growth hormone.

The request is for continuation of growth hormone. The patient is continuing to grow as her height velocity on growth hormone continues to be above 2 centimeter (cm) per year. Continuation is consistent with the standard of care. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.