Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature (ISS)

Treatment growth hormone therapy with Norditropin injection 10/1.5 mL (milliliter) #3/30 day

The insurer denied coverage for growth hormone therapy with Norditropin injection 10/1.5 mL #3/30 day

The denial is upheld

This is the case of a male diagnosed with idiopathic short stature (ISS). This request is for Norditropin. His magnetic resonance imaging (MRI) scan was normal. His bone age was of middle childhood at chronological age (CA). His testes were 2cc (cubic centimeter) bilaterally and pubic hair was at Tanner 1. The patient's height at middle childhood age was 127.8 cm [centimeters] (-2.12 standard deviation score [SDS]) and  was 131.1 cm (-2.05 SDS) with height velocity over months of 4.8 cm/yr (centimeter per year). His mother's height is 162.56 cm and father's height is 170.18 cm and mid-parental height is 172.87 cm (-0.56 SDS). 

Classic growth hormone (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 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 (standard deviation) 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 years 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 insulin-like growth factor 1 (IGF-1) or insulin-like growth factor binding protein 3 (IGFBP-3) or GH stimulation testing with a peak GH less than 10ng/ml (nanogram per milliliter).
		
The patient did not meet biochemical criteria. GH stimulation testing is not reported.
GH [growth hormone] in the treatment of ISS [idiopathic short stature] is supported by randomized controlled trials and consensus guidelines (4-9). Food and Drug Administration (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 has a delayed bone age and a normal height prediction. The patient therefore does not meet ISS criteria. 

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient is the request is not medically necessary as described below.

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

The insurer's denial of coverage for the growth hormone therapy with Norditropin injection 10/1.5 milliliter (mL) #3/30 day is upheld. Medical necessity is not substantiated.