Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature
Treatment: Norditropin FlexPro
The insurer denied Norditropin FlexPro.
The determination is upheld.

The patient was diagnosed with idiopathic short stature (ISS). This request is for Norditropin. His growth hormone (GH) stimulation test with arginine and clonidine peaked at 12.10. His Insulin-like Growth Factor 1 (IGF1) was 132 (range 49-487 ); Z-score was -0.7 standard deviations (SD); insulin-like growth factor binding protein 3 (IGFBP3) was 5880 (range 2134-6598 ). His testes were less than (<) 3.5 cubic centimeters (cc) and pubic hair was at Tanner 1.

His weight was 32.66 kilograms (kg). His height was 132.7 centimeters (cm) (-2.00 standard deviation score (SDS)) and then 139.1 cm (-1.95 SDS) with a height velocity over 1.1 years (y) of 5.8 cm/yr. His mother's height is 154.94 cm and his father's height is 170.18 and mid parental height is 169.06 cm (-1.09 SDS).
At issue is the medical necessity of Norditropin FlexPro.

No. the Norditropin FlexPro is not medically necessary for this patient.
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 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 year (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 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 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.