Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature
Treatment: Nutropin AQ NuSpin 20 milligrams (mg)/2 milliliters (ml) injection
The insurer denied coverage for Nutropin AQ NuSpin 20 mg/2 ml injection.
The denial is upheld.

This is a teenager diagnosed with idiopathic short stature (ISS). This request is for Nutropin. As reported, he was initiated on growth hormone (GH) several years ago which he has had significant improvement in growth velocity and increasing height percentiles. He is taking Nutropin 2.4 milligrams (mg) daily. 

His GH stimulation test with clonidine and arginine peaked at 24.10. His testes were 15-18 cubic centimeters bilaterally and pubic hair at tanner 3. His insulin like growth factor 1 (IGF1) was 145 (49-487).

His weight was 134.5 pounds. His pretreatment height was 134.62 centimeters (cm) (-1.90 (standard deviations) SDS). His height on therapy was 171.3 cm (-0.65 SDS)
His mother's height is 157.48 cm and father's height is 176.53 cm and mid parental height is 173.505 cm (-0.47 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 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 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 years 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 insulin-like growth factor binding protein 3 or GH stimulation testing with a peak GH less than 10.

The patient did not meet biochemical criteria. GH stimulation testing peaked at greater than 10. 

GH in the treatment of 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 ISS 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, with sound medical judgment, and in the best interest of the patient. 

The medical necessity for Nutropin AQ NuSpin 20 milligrams (mg)/2 milliliters (ml) injection is not substantiated.