Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth hormone deficiency
Treatment: Genotropin (Pre-service)
The insurer denied the Genotropin (Pre-service).
The denial is overturned. 

The patient is a male diagnosed with GHD (growth hormone deficiency). This request is for Genotropin.

The patient's GH (growth hormone) stimulation test earlier this year with arginine and clonidine peaked at 4.25 and 7.63 respectively. His height velocity is reported to be 2.2 cm (centimeters)/year. Two months ago, his testes were 1-2 cc (cubic centimeters) bilaterally, and pubic hair was at tanner 1. His MRI (magnetic resonance imaging) showed 4.5 x 3 mm (millimeters) area of decreased enhancement within the mid-portion of the inferior aspect of pituitary gland, which is a non-specific finding, however may reflect a pars intermedia cyst.

The patient's height eight months ago was 116.1 cm (-1.97 SDS [standard deviation score]). Three months ago it was 117 cm (-2.28 SDS). This gives a height velocity over five months of 1.8 cm/year.

The patient's mid-parental height is 178.562 cm (+0.24 SDS).

Yes, the requested Genotropin is medically necessary.

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

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 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 below the midparental height; 3) Height of more than 2 SD below the mean, and a height velocity over one year of more than 1 SD below the mean for chronological age, or a decrease in height SD 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 below the mean over one year, or more than 1.5 SD 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 stimulation testing, with a peak GH of less than 10 ng/ml (nanograms per milliliter).

This patient met biochemical criteria. GH stimulation testing peaked at less than 10 ng/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 2, as his height is more than 2 SD below the mean, and height velocity is more than 1 SD below the mean. The patient met height, height velocity, and biochemical criteria for the diagnosis of GH deficiency. GH in the treatment of GH deficiency is medically necessary.

Therefore, given the above, the Genotropin is medically necessary.