Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Hypopituitarism (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. 

The patient's GH (growth hormone) simulation test with arginine and clonidine peaked at 6.09.  His IGFBP3 (insulin-like growth factor binding protein 3) was 6.2 (2.7-8.9); IGF1 (insulin-like growth factor 1) was 203 (146-541).  His testes were 12-15 ml (milliliters), and pubic hair was at tanner 1.  A few months later, his testes were 10 cc (cubic centimeters) and pubic hair was at tanner 3.  His MRI (magnetic resonance image) was normal. 

The patient is adopted.  His mother's height was 172.72 cm (centimeters), and his father was shorter.  His height velocity is reported to be 7.5 cm/year (centimeters per year).
 
The patient's height was 138.43 cm (centimeters) (+0.07 SDS [standard deviation score]).  A few months later his height was 153 cm (centimeters) (-0.68 SDS [standard deviation score]) with height velocity of 4.38 cm (centimeters) per year, -2.5 SD (standard deviation) over several years with a steady decline that is ongoing despite the onset of puberty. 

Yes, the treatment with Humatrope is medically necessary.

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

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 mid-parental 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; or 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.  GH (growth hormone) stimulation testing peaked at less than 10 ng/ml (nanograms per milliliter).  The patient met height criterion 4, as he had a height velocity of more than 1.5 cm (centimeters) per year sustained over two years.  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. 

Therefore, the treatment with the treatment with Humatrope is medically necessary.