Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth hormone deficiency, Idiopathic short stature
Treatment: Norditropin Flexpro

The insurer denied coverage for Norditropin Flexpro.
The denial is overturned. 

This is a male child diagnosed with idiopathic short stature (ISS). This request is for Norditropin. His growth hormone (GH) stimulation test peaked at 17.8. His height velocity is reported to be 3.31 centimeters (cm) per year. His mother's height is 162.9 cm and father's height is 177.8 cm and so the mid-parental height is 176.85 cm. 

Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH deficiency published by the GH research society, the Lawson Wilkins Pediatric Endocrinology Society, and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists. 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: severe short stature, defined as a height more than 3 standard deviations (SD) below the mean; height more than 1.5 SD below the mid parental height SD; 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 above a certain age; 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 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. The patient did not meet biochemical criteria. GH stimulation testing peaked at greater than 10. 

In addition, GH is indicated for the treatment of GH deficiency in certain patients who do not fail GH stimulation tests based on the Lawson Wilkins Pediatric Endocrine Society (LWPES) alternate criteria which state, "No gold standard exists for the diagnosis of GHD [growth hormone deficiency]. Although children severely affected by GHD fail GH stimulation tests, there is no doubt that some children with GHD achieve stimulated GH concentrations above the arbitrary cutoffs that have been applied. A trial of GH therapy should be approved for children with otherwise unexplained short stature who pass GH stimulation tests, but who meet most of the following criteria: (1) height greater than 2.25 SD below the mean for age or greater than 2 SD below the mid parental height percentile; (2) growth velocity less than 25th percentile for bone age; (3) bone age greater than 2 SD below the mean for age; (4) low serum insulin-like growth factor 1 (IGF-I) and/or insulin-like growth factor binding protein 3 (IGFBP3); and/or (5) other clinical features suggestive of GHD." This patient's pre-treatment height was -2.37 SD; his IGF1 was low; his bone age was delayed; and his height velocity was less than the 25th percentile. He therefore met 4 of the above criteria. The patient meets accepted criteria for the diagnosis of GH deficiency.

GH in the treatment of ISS is supported by randomized controlled trials and consensus guidelines. The patient had a pretreatment height less than or equal to -2.25 SD. His height velocity and bone age would not allow him to reach a normal adult height. The request does not meet ISS criteria only because the patient meets criteria for GH deficiency.

The request is consistent with generally accepted standards of medical practice and is therefore medically necessary. The Health plan did not act reasonably, with sound judgment, or in the best interest of the patient.

The carrier's denial of coverage for Norditropin Flexpro is overturned. The medical necessity is substantiated.