Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth Hormone Deficiency. 
Treatment: Norditropin Flexpro 10/1.5ML INJ Pre-service. 

The insurer denied the Treatment: Norditropin Flexpro 10/1.5ML INJ.  
The denial is overturned. 

The patient is a male diagnosed with GHD (growth hormone deficiency). This request is for Norditropin. As reported; he has congenital hypothyroidism. He had an elevated TSH (thyroid stimulating hormone) initially detected on newborn screen. He is on 12.5 mcg (micrograms) (four days/week) of Synthroid. He has history for hypotonia and gross motor delay; his growth trends normally above the third percentile. His SNP (Single Nucleotide Polymorphism)-microarray was normal. His GH (growth hormone) stimulation test with glucagon peaked at 3.31. His morning cortisol was 6.5. His MRI (magnetic resonance imaging) was normal. His GU (genitourinary) status was at Tanner 1. 

The patient's FT4 (free thyroxin) was 1.2; TSH (thyroid stimulating hormone) was 3.62; IGF1 (insulin like growth factor 1) was < 10 (12-134); IGFBP3 (insulin like growth factor binding protein 3) was 1.3 (0.7-3.6) earlier this year. Four months prior, the patient IGF1 (insulin like growth factor 1) was 30 (12-134) and eight months after the patient's IGF1 (insulin like growth factor 1) was 14 (12-134); Z-score was -1.8 SD (standard deviations); IGFBP3 (insulin-like growth factor binding protein 3) was 1.7 (0.7-3.6).  His length was 75.6 cm (centimeters), between the 5th and 10th percentile. 

The patient had a decline in IGF1 (insulin like growth factor 1) to an undetectable level, which prompted growth hormone stimulation testing with glucagon. 

Yes, the requested Norditropin Flexpro 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). 

The diagnosis in infants can be based on low growth factors and failed growth hormone stimulation testing in the setting of other pituitary abnormalities or other physical findings suggestive of growth hormone deficiency, such as hypoglycemia or hypotonia. 

The patient has hypotonia, a low cortisol, an undetectable IGF1 (insulin-like growth factor 1), and a failed growth hormone stimulation test with glucagon. The request is consistent with generally accepted standards of medical practice, and it is therefore medically necessary.