Diagnosis: Short Stature
Treatment: Humatrope 12 Mg Cartridge
The health plan denied: Humatrope 12 Mg Cartridge
The determination is: Overturned

The patient is a male diagnosed with idiopathic short stature (ISS). This request is for Humatrope 12 milligram (mg) Cartridge (0.37 milligrams per kilogram per week). As reported, he has been doing very well on growth hormone (GH) Norditropin therapy. However, due to nationwide shortages, he is unable to gain access to GH previously approved by his insurance. His bone age was 5 years at chronological age (CA) 5 years and 3 months. His Insulin-like Growth Factor 1 (IGF1) was 24 ( 31-214), 40, and 76. His magnetic resonance imaging (MRI) was normal. The patient's height velocity improved from 3-4 centimeters per year to 10-12 centimeters per year. His pretreatment height at 4.67 years old (y/o) was 95.5 centimeters (cm), -2.52 standard deviation score (SDS), and at 5.197 y/o was 97.8 cm (-2.60 SDS) with height velocity over 6 months of 4.4 centimeters per year. His height on therapy at 6.3656 y/o was 107 cm (-2.08 SDS). His predicted adult height is 160.02 cm (-2.34 SDS). His mid parental height is 178 cm (+0.16 SDS). His most recent documented weight is 17.4 kilograms (kg).
At issue is the medical necessity of Humatrope 12 mg cartridge.
The health plan's determination of medical necessity is overturned in whole.
The requested health service/treatment of Humatrope 12 Mg cartridge is medically necessary for this patient. The peer reviewed literature is 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 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 over 2 yr of 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 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. Growth hormone stimulation testing is not reported and growth factors are normal.
Growth hormone 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 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 patient is continuing therapy and has benefited from treatment. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.