Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth hormone deficiency
Treatment: Nutropin AQ Injection 20 mg/2ml
The insurer denied Nutropin AQ Injection 20 mg/2ml.
The determination is overturned.

The patient was diagnosed with growth hormone deficiency (GHD). This request is for Nutropin. As reported, he was approved and started growth hormone (GH) treatment (Nutropin); he is taking Nutropin 1.8 milligrams (mg) daily, 2 missed doses, (0.37 milligrams per kilogram per week [mg/kg/wk]). He has been on attention deficit hyperactivity disorder (ADHD) medications. His growth charts revealed his height went from 32 % (percentile) to 17 % and weight from 24 % (percentile) to 8 %. His GH stimulation test with glucagon and L-dopa (l-3,4-dihydroxyphenylalanine) peaked at 7.6 and 5 respectively. His magnetic resonance imaging (MRI) was normal. His height velocity is improved from 3 centimeters per year (cm/yr) to 7 cm/yr. His testes were 6 cubic centimeters (ccs) bilaterally and pubic hair was at Tanner 2. His weight was 33.934 kilograms (kg).
His pretreatment height was 138.41 cm (-1.49 standard deviation score (SDS)) and then 140.69 cm (-2.02 SDS) with height velocity over 1y of 2.1 cm/year.
His height on therapy was 149.10 cm (-1.81 SDS).
His mother's height is 162.56 cm and father's height is 176.53 cm and mid parental height is 176.045 cm (-0.11 SDS).
At issue is the medical necessity of Nutropin AQ Injection 20 mg/2ml, use as directed (6 milliliters (ml) per month).

Yes. The requested Nutropin is medically necessary.
The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:
Classic GH deficiency
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 1) severe short stature, defined as a height more than 3 standard deviations (SD) 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 yr more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year (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 Insulin-like Growth Factor-1 (IGF1) or Insulin-like growth factor binding protein-3 (IGFBP3) or growth hormone (GH) stimulation testing with a peak GH less than 10 nanograms per milliliter (ng/ml).
This patient met biochemical criteria. GH stimulation testing peaked at less than 10ng/ml. The patient met height criterion 2 as his height is more than 1.5 SD below target height SD. The patient also met auxological criterion 3 as pretreatment height was more than 2 SD below the mean and pretreatment height velocity was more than 1 SD below the mean. The patient met both height and height velocity and biochemical criteria for the diagnosis of GH deficiency. GH in the treatment of GH deficiency is medically necessary.
The patient is a continuing therapy patient. Pubertal dosing can exceed 0.3 mg/kg/week. The requested dose of 0.38 mg/kg/week is appropriate for pubertal dosing. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.