Diagnosis: Growth Hormone Deficiency (GHD).
Treatment: Norditropin Flexpro 10/1.5mL (milliliter) injection.

The insurer denied coverage for Norditropin Flexpro 10/1.5mL injection.

The denial is upheld.

This is a pediatric patient diagnosed with growth hormone deficiency (GHD). This request is for Norditropin. His growth hormone (GH) stimulation test with insulin and clonidine peaked at 2.2 and 5.7 respectively. His IGF1 (insulin-like growth factor 1) was 110 (59-275) and IGFBP3 (insulin-like growth factor binding protein (IGFBP) )was 2.6 (1.6-6.5). Magnetic Resonance Imaging (MRI) was normal. Genitalia was at tanner 1.

Height was 110 cm (centimeters) (-1.41 SDS [standard deviation score]) and later it was 121.92 cm (-1.55 SDS) with height velocity of 5.3 centimeters (cm)/year (yr) over 2.25 years. His mother's height is 160.02 cm and father's height is 182.88 cm and mid parental height is 177.95 cm (+0.15 SDS).

The peer reviewed literature including consensus clinical guidelines, randomized 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 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 yr more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 yr in children over 2 yr of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 yr or more than 1.5 SD sustained over 2 yr. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10ng/ml [nanogram per deciliter].

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 IGFBP-3 was normal predicted adult height is normal. The pediatric endocrine society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing.

Idiopathic Short stature:

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]. 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."

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

The insurer's denial of coverage for Norditropin Flexpro 10/1.5mL injection is upheld. Medical necessity is not substantiated.