Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth hormone deficiency
Treatment: Humatrope
The insurer denied the Humatrope.
The denial is overturned. 

The patient is a male diagnosed with GHD (growth hormone deficiency). This request is for Humatrope. As reported; he also has positive Celiac antibodies and he was treated. His MRI (magnetic resonance image) was normal. His GH (growth hormone) stimulation test with arginine and clonidine peaked at 9.21. His testes are 2 ml (milliliters) bilaterally, and pubic hair is at tanner 1. His height velocity is reported to be 4.37 cm/yr (centimeters per year).

The patient's IGF1 (insulin-like growth factor 1) was 45 (108-293). His IGFBP3 (insulin-like growth factor binding protein 3) was 1.99 (2.04-5.38). Three months prior his IGF1 (insulin-like growth factor 1) was 50 (108-293). His IGFBP3 (insulin-like growth factor binding protein 3) was 1.66 (2.10-5.47).

He had height velocity over 11 months of 4.5 cm/yr (centimeters per year).

The patient's mother's height is 166.37 cm (centimeters). His father's height is 177.8 cm (centimeters). His mid-parental height is 178.585 cm (centimeters) (+0.24 SDS [standard deviation score]).

Yes, the treatment with Humatrope is medically necessary.

The peer-reviewed literature, including consensus clinical guidelines and randomized controlled trials, are summarized below:

Classic GH (growth hormone) deficiency
Classic GH (growth hormone) deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH (growth hormone) deficiency published by the GH (growth hormone) 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 auxological, biochemical and sometimes radiological findings.

The auxological criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are
1)	Severe short stature, defined as a height of more than 3 SD (standard deviation) below the mean;
2)	Height of more than 1.5 SD (standard deviation) below the midparental height;
3)	Height of more than 2 SD (standard deviation) below the mean, and a height velocity over one year of more than 1 SD (standard deviation) below the mean for chronological age, or a decrease in height SD (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 of more than 2 SD (standard deviation) below the mean over one year, or more than 1.5 SD (standard deviation) sustained over two years.

The biochemical criteria include low IGF1 (insulin-like growth factor 1) or IGFBP3 (insulin-like growth factor binding protein 3) or GH (growth hormone) stimulation testing, with a peak GH (growth hormone) of less than 10 ng/ml (nanograms per milliliter).

This patient met biochemical criteria. His GH (growth hormone) stimulation testing peaked at less than 10 ng/ml (nanograms per milliliter). The patient had a low IGF1 (insulin-like growth factor 1). The patient met height criterion 2, as his height is more than 1.5 SD (standard deviations) below target height SD (standard deviations). The patient met both height and height velocity and biochemical criteria for the diagnosis of GH (growth hormone) deficiency. GH (growth hormone) in the treatment of GH (growth hormone) deficiency is medically necessary.