Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature (ISS)

Treatment Norditropin Flexpro 15 milligram per 1.5 milliliter pen injector.

The insurer denied coverage for Norditropin Flexpro 15 milligram per 1.5 milliliter pen injector.

The denial is overturned.

The patient was diagnosed with idiopathic short stature (ISS). This request is for Norditropin (1.6 milligram [mg]). Her growth hormone (GH) stimulation test peaked at 21. Her height velocity is reported to be 10.95 centimeter/year (cm/yr). Her insulin growth factor (IGF)1 was 143; insulin growth factor binding protein (IGFBP)3 was 3972. Later, her IGF1 was 182, and IGF1 was 236. 

The patient pubic hair was at tanner 1 and breast at tanner 2; very small breast budding bilaterally. Months later, her pubic hair was at tanner 2; breasts at tanner 2-3. 

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 [standard deviations] 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 (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 10ng/ml (nanograms per milliliter).
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10. 

Idiopathic Short stature. Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines  [4, [5, [6, [7, [8, [9]. FDA (Food and Drug Administration) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS (standard deviation score) 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."

The patient had a pretreatment height less than or equal to -2.25 SD.  The height velocity and bone age did not predict a normal adult height.  The patient therefore meets idiopathic short stature criteria. 

The patient had a pre-treatment height less than or equal to -2.25 SD. The height velocity and bone age did not predict a normal adult height.  The patient therefore meets idiopathic short stature criteria. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

The references provided are the most current/relevant to the case.

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Norditropin Flexpro 15 milligram per 1.5 milliliter pen injector is overturned. Medical necessity is substantiated.