Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Growth hormone (GH) deficiency.
Treatment:  Nutropin AQ 20 mg (milligrams) /2 ml (milliliters) (6 per month).

The insurer denied coverage for Nutropin AQ 20 mg/2 ml (6 per month).  The denial is upheld/overturned.

This is a teenaged male diagnosed with growth hormone (GH) deficiency. This request is for Nutropin 2 milligram (mg) [0.33 mg/ kilogram (kg)/ week]. As reported, he started GH therapy. His GH stimulation test with glucagon and levodopa peaked at 4.6 and 3.7 respectively. His magnetic resonance imaging (MRI) was normal. His testes were 4-5 cubic centimeters (cc), and his pubic hair was at tanner 2. His weight was 41.305 kg. His pretreatment height was 121.589 centimeters (cm) [-2.43 standard deviation score (SDS)]. His height on therapy was 145.11 cm (-2.02 SDS).

Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH deficiency published by the GH research society the Lawson Wilkins Pediatric Endocrinology Society, and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists. The 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 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 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 insulin-like growth factor 1 (IGF1) or insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms/ milliliters (ng/ml).
		
This patient met biochemical criteria. GH stimulation testing peaked at less than 10ng/ml. The patient met height criterion 3 as his height prior to treatment was more than 2 SD below the mean and a 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 denial was based on the dose being 0.33 mg/kg/week which exceeds the policy's maximum dose of 0.3 mg/kg/week.
The patient is in puberty. Pubertal dosing can sometimes exceed 0.3 mg/kg/week up to 0.45 mg/kg/week at the discretion of the physician and depending on the patient's height velocity, target height, predicted adult height. The patient's dose is not excessive. The request is consistent with generally accepted standards of medical practice. The request is therefore medically necessary.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Nutropin AQ 20 mg/2 ml (6 per month) is substantiated.