Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth hormone deficiency
Treatment is Genotropin
The insurer denied coverage for Genotropin
The denial is upheld

This is a patient diagnosed with growth hormone (GH) deficiency. This request is for Genotropin 15 mg (milligrams) /day. As reported; he has been on GH therapy. His GH stimulation test with arginine and glucagon peaked at 8.6. His MRI (magnetic resonance imaging) of the pituitary showed T2 hyperintense (area of high intensity) non-enhancing mass within the center of pituitary gland; differential diagnosis should include pituitary adenoma and Rathke's cleft cyst. His height velocity on therapy is reported to be 5.2 cm (centimeters)/yr (year). His pretreatment height velocity is reported to be 4.4 cm/yr. His IGF1 (Insulin-like growth factor 1) was 439. His testes were at tanner 4-5 and pubic hair was at tanner 5. His IGF1 was 111 (61-252 mean 137); IGFBP3 (insulin-like growth factor binding protein) was 4.2 (2.22-5.66). 

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 (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 year 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 (nanograms)/ml (milliliter).

The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. GH stimulation testing peaked at less than 10ng/ml. IGF-I was normal.

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 [4-9]. FDA (food and drug administration) 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." [10-13]

The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet idiopathic short stature criteria. 

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

The insurer's denial of coverage for Genotropin is upheld. Medical Necessity is not substantiated.