Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth hormone deficiency.
Treatment: Genotropin.
The insurer denied: Genotropin.
The denial is: Upheld.

The patient is a male who is seeking growth hormone (GH) treatment. Apparently, he is being followed by pediatric endocrinology for short stature and poor weight gain and the presumptive diagnosis was constitutional delay in growth and pubertal development.

His height was 143.8 centimeters (cm) (-1.76 standard deviation [SD]), 150.7 cm (-1.69 SD), and 158.4 cm (-1.63 SD). His evaluation showed unremarkable complete blood count (CBC), normal thyroid function tests (TFTs), negative celiac screen and normal insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3).
When seen for follow up, his height was 160.6 cm (-1.53 SD), and weight was 48.3 kilograms (kg) (-1.3 SD).  Based on his bone age, his predicted adult height was calculated as 63-64 inches. He was started on aromatase inhibitor to delay bone age advancement and treatment with GH was requested under the indication of idiopathic short stature (ISS). However, the health plan denied the coverage of GH for ISS. He subsequently underwent GH stimulation testing and his peak GH response after arginine and clonidine was 7.79 nanograms/milliliter (ng/ml), and treatment with GH was requested for GH deficiency.

The health plan's determination is upheld.

Treatment with Genotropin is not medically necessary for this patient.
The Food and Drug Administration (FDA) approved injectable somatropin (Humatrope) for the treatment of ISS, also called non-GH-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 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 but as the heights of his parents are not known it is not known how short he is for his genetics. His initial height was 1.76 SD below the mean for age and most recent height was 1.53 SD below the mean for age. As this patient's height has never been 2.25 SD below the mean for age, he does not meet the criteria for the diagnosis of ISS set forth by FDA for growth hormone treatment.
Apparently, his bone has advanced in a short period of time before allowing catch up growth, likely from rapid pubertal progression which limits his adult height prognosis. However, height prediction based on bone age is not the criterion used in the definition of ISS.
Diagnosis of growth hormone deficiency (GHD) involves clinical history (with primary consideration given to genetic background, degree of short stature and growth velocity), physical examination, auxologic data, bone age determination, measurement of IGF-1 and IGFBP-3, provocative GH testing and a magnetic resonance imaging (MRI) of the pituitary.
In the literature, near final height has been defined for females and males and used it as one of the criteria for discontinuing GH. This patient's bone age is already at the defined age for males, suggesting that he has finished most of his growth and GH treatment at this point is unlikely to improve his final adult height.
Genotropin is not medically necessary for this patient.