Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature (ISS)
Treatment: Norditropin Flexpro
The insurer denied the norditropin flexpro.
The health plan's determination is upheld. 

The patient is a female who is diagnosed with idiopathic short stature (ISS). The patient had Crohn's disease and she has not yet reached menarche. Her growth hormone (GH) stimulation test with Arginine and Clonidine peaked at 12.7. The patient's height velocity is reported to be 3.9 centimeters (cm) per year. Her breasts were at a density of 2-3 and her pubic hair was at tanner 2. The patient's Insulin-like Growth Factor 1 (IGF1) was 162 (out of 90-581); the comparison of bone density to the average values for a person of the same age and gender (Z-score) was a negative (-) 0.1 standard deviation (SD). Two years later her IGF1 was 189 (out of 90-581) and her Z-score was -0.4 SD.
Her weight was was 42.5 kilograms (kg).
Her height was 139.8 cm (-2.05 standard deviation score (SDS)), and a year later it was 144 cm (-2.15 SDS) with a height velocity over 0.85 the year (y) of 4.9 cm per y.
Her mother's height is 151.77 cm and father's height is 185.42 cm and the mid parental height is 162.09 cm (-0.19 SDS).

The requested health service and treatment of Norditropin Flexpro is not medically necessary for the patient. The peer reviewed literature including consensus clinical guidelines and 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 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 (yr) more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over one yr 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 yr or more than 1.5 SD sustained over 2 years. The biochemical criteria include low Insulin-like Growth Factor 1 (IGF1) or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms/milliliter (ng/ml).
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10.
Growth hormone in the treatment of idiopathic short stature (ISS) 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."[10-13]
The patient does not have a pre-treatment height of less than or equal to -2.25 SD. Furthermore, the patient has Crohn's disease which can be a contributor to short stature. The patient's height prediction is expected to be normal. The patient therefore does not meet idiopathic short stature criteria. The request does not meet any nationally accepted criteria for the use of growth hormone.