Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature.

Treatment: Growth hormone therapy.

The insurer denied coverage for growth hormone therapy.

The denial is upheld. 

This male patient was diagnosed with growth hormone deficiency (GHD). The request is for Norditropin. The patient's growth hormone (GH) stimulation test with arginine and glucagon peaked at 6.8. His height velocity is reported to be 9.2 cm/year. The bone age between 11 and 13 years at chronological age (CA) of 14s and was 14 years between th chronological age (CA) 14 years and a few months.  Magnetic resonance imaging (MRI) was normal. His testes are 12-15 ml bilaterally and pubic hair is at tanner 2-3. His IGF1 was 314 (page 34); IGFBP3 was 4.71.  Later testing showed his insulin-like growth factor 1 (IGF1) was 450 (156-554 mean 318); insulin-like growth factor-binding protein 3 (IGFBP3) was 4.86 (2.58-6.27). 

His mother's height is 157.48 cm and father's height is 180.34 cm and mid parental height is 175.41 cm (-0.20 SDS[standard deviations]).  His height at 14.86 years-old was 157.5 cm (-1.44 SDS).

The peer reviewed literature including consensus clinical guidelines, randomize controlled trials are summarized below:

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 above 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 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 10ng/ml.
		
The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal.  Growth factor levels were normal. GH stimulation testing peaked at less than 10ng/ml.

The Pediatric Endocrine Society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing.

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4, 5, 6, 7, 8, 9].  The 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 pre-treatment height less than or equal to -2.25 SD.  The patient therefore does not meet idiopathic short stature criteria. The patient does not meet any nationally accepted criteria for use of growth hormone.  

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

The carrier's denial of coverage for Norditropin for Pediatric Growth Hormone Deficiency (GHD) is upheld. The medical necessity is not substantiated.