Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature
Treatment: Norditropin Flexpro 10MG (milligrams)/1.5
The insurer denied the Norditropin Flexpro 10MG/1.5.
The denial is overturned.

The patient is a female diagnosed with ISS (idiopathic short stature). This request is for Norditropin 0.9 mg (milligrams) daily (0.3 milligrams x [times] kilogram x week). Her GH (growth hormone) stimulation test with arginine and clonidine peaked at 13.2. Her height velocity is reported to be 5 centimeters (cm)/year. Approximately a year ago, bilateral breast buds were noted. Approximately five months ago her breasts were at tanner 2. Her IGF1 (insulin-like growth factor 1) was 214 (49-451). Height prediction is reported to be 58 inches.

The patient's weight was 22.5 kilograms. The patient's height approximately a year ago was 118.2 cm (- [minus] 2.47 SDS [standard deviation score]) and approximately five months ago was 122.5 cm (-2.28 SDS) with height velocity over 0.79 years of 5.4 cm/year.

Yes, the requested Norditropin is medically necessary.

The peer-reviewed literature, including consensus clinical guidelines and 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 auxological, biochemical and sometimes radiological findings.

The auxological criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are
1) Severe short stature, defined as a height of more than 3 SD (standard deviations) below the mean; 2) Height of more than 1.5 SD below the midparental height; 3) Height of more than 2 SD below the mean, and a height velocity over one year of more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over one year in children over two years of age; 4) In the absence of short stature, a height velocity of more than 2 SD below the mean over one year, or more than 1.5 SD sustained over two years.

The biochemical criteria include low IGF1 or IGFBP3 (insulin-like growth factor binding protein 3) or GH stimulation testing, with a peak GH of less than 10 ng/ml (nanograms per milliliter).

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

GH in the treatment of ISS is supported by randomized controlled trials and consensus guidelines (4-9). FDA (Food and Drug Administration) 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 ISS criteria.

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

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient, as the request is medically necessary, as described above.