Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature

Treatment: Nutropin AQ Nuspin 10 Injector

The insurer denied coverage for Nutropin AQ Nuspin 10 Injector

The denial is overturned

This is a patient diagnosed with Idiopathic Short Stature (ISS). This request is for Nutropin. As reported the patient started growth hormone (GH) therapy over a year ago. The patient's GH stimulation peaked at 15.6. The patient's bone age was 10years (y)-11y at calculated age (CA) 13y7months (m); later it was 12y6m at CA 14y8m. The patient's testes were 12-15 centimeters cubed (cc) bilaterally and pubic hair was at tanner 3-4. The patient's weight was 45 kg.

The patient's pretreatment height 13.84 y was 143.4 centimeters (cm) (-2.35 standard deviations (SDS)) and at 14.478y was 145 cm (-2.58 SDS) with height velocity over 7 months of 2.5 cm/y.
The patient's height on therapy at 15.42 y/o was 157.4 cm (-1.79 SDS).  The patient's predicted adult height is 172.72 cm (-0.58 SDS). The patient's mother's height is 162.56 cm and father's height is 167.64 and mid parental height is 171.6 cm (-0.73 SDS)

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 patient met both height and height velocity criteria (Documented: The patient's pretreatment height at 13.84y was 143.4 cm (-2.35 SDS) and at 14.478y was 145 cm (-2.58 SDS) and height velocity over 7 months of 2.5 cm/y). GH stimulating hormone peaked more than 10 (the patient's GH stimulation peaked at 15.6).

The patient does not meet criteria for growth hormone deficiency as the patient's 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 had a pretreatment height less than or equal to -2.25 SD. The patient's height velocity and bone age would not allow the patient to reach a normal adult height. The request therefore meets idiopathic short stature criteria.

The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Nutropin AQ Nuspin 10 Injector is substantiated.