Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollees parent is requesting authorization and coverage for the medication, Nutropin AQ NuSpin. The enrollee has type 1 diabetes mellitus and poor growth. His growth velocity is below normal. His current height places him in the tenth percentile. His endocrinologist placed him on growth hormone (GH) therapy and indicates the enrollees growth velocity is 2.76 centimeters over a nine month span, which is below the tenth percentile for growth velocity for gender, age and pubertal status. Insulin-like growth factor (IGF-1) level is greater than -2 standard deviation scores (SDS) from the mean for age and pubertal status, which is low. He has a current height on the tenth percentile, while his midparental height (MPH) is 62 or 97th percentile. He has a final height prediction of 68.5 inches, which is greater than 2 SDS below his MPH. He has a pituitary gland without discreet tumor, but with abnormal enhancement. Other sources of poor growth have been ruled out. Classic growth hormone deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of growth hormone deficiency, and the medical guidelines for growth hormone use. The diagnosis of growth hormone deficiency 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  severe short stature, defined as a height more than three standard deviation scores (SDS) below the mean; a height more than one and a half SDS below the midparental height; a height more than two SDS below the mean and a height velocity over one year more than one SDS below the mean for chronological age; or a decrease in height SDS of more than one half over one year in children over two years of age; in the absence of short stature, a height velocity more than two SDS below the mean over one year or more than one and a half SDS sustained over two years. The biochemical criteria include low insulin-like growth factor (IGF)1,low insulin-like-growth-factor-binding-protein-3 (IGFBP-3) or growth hormone stimulation testing with a peak growth hormone less than 10ng/ml. Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines. Approval for this indication is for non-growth hormone-deficient short stature, defined by a 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 enrollees 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. This enrollee had a pre-treatment height of -1.01 SDS.  Growth hormone treatment for a pretreatment height that is not less than or equal to -2.25 SDS is not medically indicated. The request does not meet any nationally accepted criteria for use of growth hormone. Final Result: The reviewer determined that the requested service is not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in endocrinology, diabetes & metabolism and pediatric endocrinology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or similar medical condition.