Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature (ISS)

Treatment: Norditropin

The insurer denied coverage for Norditropin.

The denial is upheld.

This is a male diagnosed with ISS. This request is for Norditropin. His growth hormone (GH) stimulation test with arginine and glucagon peaked at 44. His insulin-like growth factor binding protein 3 (IGFBP-3) was 4.39; insulin-like growth factor 1 (IGF-1) was 442.

His height velocity is 5.8 centimeters (cm)/year. His bone age is approximately 1 year less than his chronological age. His testes were close to 15 milliliters (ml) and pubic hair was at tanner 3 to 4. His weight was 54.4 kilograms (kg).

His height approximately 1 year ago was 155 cm [-1.12 standard deviation score (SDS)] and approximately 5 months ago was 159.7 cm (-1.13 SDS) with height velocity over 0.83 years of 5.7 cm/year. His mid-parental height is 168.7 cm (-1.14 SDS).

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 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 standard deviations (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 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 IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10.
		
The patient did not meet biochemical criteria. GH stimulation testing peaked at greater than 10. 

GH 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 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 therefore does not meet ISS criteria. The patient has a normal height and a normal speed of growth.

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

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

The insurer's denial of coverage for Norditropin is upheld. Medical necessity is not substantiated.