Diagnosis: Endocrine/Metabolic/Nutritional/Short Stature/idiopathic short stature
Treatment: Pharmacy/Prescription Drugs/Humatrope 12 mg cartridge 0.9 subcutaneously injected daily
The health plan denied the requested Humatrope 12 mg cartridge 0.9 subcutaneously injected daily as not medically necessary. The health plan's determination is upheld.

The patient is a male who is seeking growth hormone (GH) treatment under the indication of idiopathic short stature (ISS). His mother's height is 5 feet 3 inches and father's height is 5 feet 10 inches. His growth chart shows his height around 10% (percentile) since the age of 5 years. He is being followed in the pediatric endocrinology clinic. His initial evaluation was unremarkable (results not available).

At a follow up visit, his height was 115.1 centimeters (cm) (-1.38 standard deviation (SD)). His growth velocity was calculated as 5.9 cm per year.

Based on his bone age, his adult height prediction was calculated as 65.2 inches. He underwent GH stimulation testing and his peak GH response was 13.1 nanograms/milliliter (ng/ml) after Arginine and 17.9 ng/ml after Clonidine. Treatment with GH is requested under the indication of idiopathic short stature (ISS).
At issue is the medical necessity for the requested health service/treatment of Humatrope 12 milligram (mg) cartridge 0.9 subcutaneously injected daily.

I uphold, in whole, the health plan's determination of medical necessity.

No. This patient is seeking GH treatment under the indication of ISS. In 2003, the US Food and Drug Administration (FDA) approved injectable somatropin for the treatment of ISS, also called non-GH-deficient short stature, defined by height standard deviation score (SDS) <=-2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes of short stature that should be observed or treated by other means.
Consensus on the definition of ISS and on the management of children with ISS was published in 2008. In that statement, ISS was defined as an individual with a height more than 2 SD below the mean without findings of any disease.
This patient is relatively short for his age and genetics but growing normally. His height was 1.38 SD (not 2.25 SD) below the mean for age and 1.16 SD below his genetics (mid-parental height +/- 1 SD 69+/-2''). His growth velocity was 5.9 cm per year which is normal (56% (percentile) for age). He clearly does not meet the criteria for the diagnosis of ISS.
The Pediatric Endocrine Society Guidelines for Growth Hormone and Insulin-Like Growth Factor-1 Treatment in Children and Adolescents recommend GH treatment for idiopathic short stature (height -2.25 SD) on a case-by-case basis after assessment of physical and psychological burdens, and discussion of risks and benefits. This patient clearly does not meet the definition of ISS.
As this patient's height is not 2.25 SD below the mean for age and he is growing normally, he does not qualify for growth hormone treatment under ISS indication.