Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Endocrine/Metabolic/Nutritional/Pediatric Growth Hormone Deficiency.
Treatment:  Norditropin.
The health plan denied the requested medication, Norditropin. The health plan's determination is upheld, in whole.

This is a male diagnosed with growth hormone deficiency (GHD). This request is for Norditropin. As reported, he has an atrioventricular (AV) heart block, and the use of Clonidine is contraindicated. He also has type 1 diabetes mellitus (T1DM). His growth hormone (GH) stimulation with Arginine peaked at 2.57. His bone age was 12 years 6 months at chronological age (CA) 13 years 2 months. His height velocity is reported to be 1.8 centimeter (cm)/year. His Insulin-like Growth Factor 1 (IGF1) was 43.
The patient's weight was 37.5 kg (kilograms). His height at 12.77 years old was 143 cm (-1.50 standard deviation score (SDS)) and at 13.42 years old was 144 cm (-1.95 SDS) with height velocity over 8 months of 1.5 cm/year. The midparental target height is 66.5 inches, 168.9 cm, -1.11 standard deviation (SD). Results later were 130.8 cm. 13.2 cm over 2.45 year or 5.4 cm/year.
At issue is the medical necessity of Norditropin.

The health plan's determination of medical necessity is upheld, in whole.

No. The requested health service/treatment of Norditropin is not medically necessary for this patient.
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 below the mean; 2) height more than 1.5 SD below the midparental height SD; 3) 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 years of age; 4) 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 nanograms/milliliter (ng/ml).
The patient did not meet height and height velocity criteria, as pretreatment height and 1- and 2-year height velocity are normal or not provided. GH stimulation testing with Arginine alone peaked at less than 10ng/ml. Given the fact that the patient's height is not more than 2 SD below the mean, and the fact that the only auxological criterion being relied upon is height velocity, height velocity over less than one year is not appropriate to make the diagnosis of growth hormone deficiency. The patient's height velocity over 2.45 years is normal.
The Pediatric Endocrine Society recommends against making a diagnosis of growth hormone deficiency based solely on a failed growth hormone stimulation testing with one test. My recommendation is to uphold the denial, as the patient does not meet accepted criteria for the diagnosis of growth hormone deficiency.