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201906-118009

2019

Oxford

PPO

Endocrine/ Metabolic/ Nutritional

Pharmacy/ Prescription Drugs

Medical necessity

Overturned

Case Summary

Diagnosis: Growth hormone deficiency

Treatment: Nutropin

The insurer denied growth hormone therapy. This denial was reversed.

This child has a history of mild autism. Per the early 2019 office visit note with the Pediatric Endocrinologist, the patient was there for follow up on his growth. He had been receiving growth hormone since the Fall 2018, but ran out. There was a family history of short stature. The patient's height was 126.5 cm and his weight was 28 kg. His bone age had been recently interpreted to be between the 8 and 9 year old standards. Given his current height, using the tables in Greulich and Pyle, his predicted adult height was 62.5". The patient was noted to qualify for growth hormone with a diagnosis of idiopathic short stature.

The 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 more than 3 standard deviations (SD) below the mean; 2) height more than 1.5 SD below the midparental height; 3) height more than 2 SD below the mean and a height velocity over 1 year more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year in children over 2 years of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 year or more than 1.5 SD sustained over 2 years. The biochemical criteria include low insulin like growth factor 1 [IGF1] or insulin like growth factor binding protein 3 [IGFBP3] or GH stimulation testing with a peak GH less than 10ng/ml. The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported.

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines. Food and Drug Administration [FDA] approval for this indication is for "non-growth hormone-deficient short stature, defined by height standard deviation score [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 has a pretreatment height less than or equal to -2.25 standard deviation [SD]. The patient's height velocity and bone age are reported to a predicted adult height of 62.5 inches. The patient therefore met idiopathic short stature criteria. The patient is a continuing therapy patient. Continuation of growth hormone is indicated until the patient reaches final adult height. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

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