Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pediatric Growth Hormone Deficiency.
Treatment: Norditropin.
The insurer denied the Norditropin.
The denial is overturned.

This patient is a male diagnosed with growth hormone deficiency (GHD). This request is for Norditropin. His growth hormone stimulation test with clonidine and again approximately three months later with glucagon peaked at 4.5 and less than (<) 0.1 respectively. His testes were three cubic centimeters (cc) bilaterally with tanner I as well as pubic hair. His magnetic resonance image (MRI) was normal. His insulin-like growth factor one (IGF1) was 160 (80-398 page 28); z-score was - (minus) 0.5 standard deviations (SD). 

His weight was 66 pounds.  His height was 123 centimeters (cm) (- [minus] 2.09 standard deviation scores [SDS]).  The patient's mother's height is 172.72 centimeters (cm) and father's height is 180.34 centimeters and mid parental height is 183.03 centimeters (+ [plus] 0.87 standard deviations scored [SDS]).

Yes, the proposed Norditropin is medically necessary.
The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:

Classic growth hormone deficiency:
Classic growth hormone deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of growth hormone deficiency published by the GH Research Society [1], the Lawson Wilkins Pediatric Endocrinology Society [2, [3], and the medical guidelines for GH (growth hormone) 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 3.0 standard deviations below the mean; 2) height more than 1.5 standard deviations below the mid parental height SD; 3) height more than 2.0 standard deviations below the mean and a height velocity over one year more than 1.0 standard deviations below the mean for chronological age, or a decrease in height standard deviation 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 more than 2.0 standard deviations below the mean over one year or more than 1.5 standard deviations sustained over two years. The biochemical criteria include low insulin like growth factor one (IGF1) or insulin binding protein three (IGFBP3) or growth hormone stimulation testing with a peak growth hormone less than ten nanograms per milliliter (ng/ml).

This patient met biochemical criteria. Growth hormone stimulation testing peaked at less than ten nanograms per milliliter (ng/ml). The patient met height criterion #2 as his height is more than 1.5 standard deviations (SD) below target height standard deviation. The patient met both height and height velocity and biochemical criteria for the diagnosis of growth hormone deficiency. Growth hormone in the treatment of growth hormone deficiency is medically necessary.

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