Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature
Treatment: Norditropin FlexPro 10 milligram (mg)/1.5 milliliter (ml) SC SOPN (subcutaneous solution pen injector)
The insurer denied coverage for Norditropin FlexPro 10 milligram (mg)/1.5 milliliter (ml) SC SOPN
The denial is upheld

This is a teenager diagnosed with idiopathic short stature (ISS). This request is for Norditropin. His height velocity is reported to be 6.7 centimeters per year (cm/yr). He is at tanner 3. His insulin like growth factor 1 (IGF1) was 297 and insulin like growth factor binding protein 3 (IGFBP3) was 3.62.

His weight was 41.50 kilograms.
His height 150.5 cm (-2.24 standard deviation (SDS))
His mother's height is 160.02 cm and father's height is 162.56 cm and mid parental height is 167.8 cm (-1.26 SDS)
His predicted adult height is 171 cm, -0.81 SD.  

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

Classic growth hormone (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; 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 10.

The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported and growth factors are normal.

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 had a pretreatment height of -2.24 SD. The patient's height velocity and bone age would allow the patient to reach a normal adult height. 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.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Norditropin FlexPro 10 milligram (mg)/1.5 milliliter (ml) SC SOPN is not substantiated.