Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Small for Gestational.
Treatment: Norditropin.
The insurer denied coverage for Norditropin.
The denial is overturned.

The patient is a female diagnosed with small for gestational. She was born at 35 week gestation with birth weight 4 pounds 2 ounces/1871 grams (twin B). The cut off for small for gestational is 1717 grams. The patient was therefore not small for gestational at birth. Her bone age in her preteen was younger at chronologic age. Her breasts and pubic hair were at Tanner 1. A few months later, her breasts and pubic hair were at Tanner 2. Next, her insulin-like growth factor 1 (IGF1) was 102. Insulin like growth faector binding protein 3 (IGFBP3) was 3580. Her IGF1 was 175; IGFBP3 was 4640. Her height one year was 122 centimeters.  A year later her height was 137.7 centimeter. Her mother's height is 161.29 centimeter and father's height is 182.88 centimeters.  

Growth hormone for the treatment of children who are small for gestational and who fail to exhibit catch-up growth is standard of care. This indication has approval from the Food and Drug Administration [1] support from consensus guidelines [2, [3, [4] and randomized controlled trial evidence to support its use. [5, [6, [7, [8, [9] The most recent and most relevant consensus guidelines are those of the combined meeting of the International Societies of Pediatric Endocrinology and the Growth Hormone Research Society.[2] Here it is recommended that if a patient fails to exhibit catch-up growth by either two or four years, that growth hormone be initiated.  The diagnosis of small for gestational with failure to catch up is made after a growth point at age of 2. This diagnosis can be made at any time after age 2 assuming that the patient has not had catch up growth.  For example if a patient is found at age 8 has still not caught up, then this patient would qualify for the small for gestational indication. This patient was not small for gestational at birth. The request does not meet small for gestational criteria.

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines.[4, [12, [13, [14, [15, [16]  Food and Drug Administration approval for this indication is for "non-growth hormone-deficient short stature, defined by height small for gestational 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 had a pretreatment height less than or equal to -2.25 standard deviations. The patient's height velocity and bone age would not allow the patient to reach a normal adult height. The request therefore meets idiopathic short stature criteria. Given the patient's growth failure, the request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

The health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

The insurer's denial of coverage for Norditropin to treat growth failure is reversed. Medical necessity is substantiated.