Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth failure.
Treatment: Nutropin AQ Nuspin 10.
The insurer denied the Nutropin AQ Nuspin 10.
The denial is upheld. 

No, the treatment with Nutropin AQ Nuspin 10 is not medically necessary.

The patient is a male diagnosed with growth failure secondary to Crohn's disease. This request is for Nutropin. As reported, he does not have growth hormone deficiency but growth has been significantly been affected due to chronic disease and inflammation. He was on Remicade in the past, which was effective for some time. He was on oral Budesonide, and he had approximately three months in total of Prednisone therapy.  He was also on methotrexate with adverse effects. Most recently, he started Stelara without improvement at this time.   

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

Classic GH deficiency
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 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 10ng/ml.
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported.

Idiopathic short stature
Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines ([4, 5, 6, 7, 8, 9). FDA approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means."

The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet idiopathic short stature criteria. 

There are no studies showing efficacy of growth hormone in Crohn's disease with improvement in final adult height. The pediatric endocrine society does not recommend use of growth hormone in Crohn's disease.

The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.


The patient height was initially at the 50 % and in line with the mid parental height. However, his height is now at the 8 %, and hence quite a bit below his genetic potential.  His testes are 12-15 ml bilaterally and pubic hair is at tanner 3. His pretreatment height velocity is reported to be 4.2 cm/year.

The patient's mother's height is 167.64 cm, and his father's height is 175.26 cm. His mid-parental height is 177.95 cm (0.15 SDS [standard deviation score]). His height was 162.1 cm (-1.38 SDS). The note from this visit it reports that the patient is not on growth hormone (GH). It reports a height velocity of 14.61 cm per year.