Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature (ISS).

Treatment Norditropin, 2.8 milligrams (mg) daily, 3 syringes for 28 days.

The insurer denied coverage for Norditropin, 2.8 milligrams daily, 3 syringes for 28 days.

The denial is overturned.

This is a female diagnosed with ISS. This request is for Norditropin. As reported; she started on GH (growth hormone) therapy) and grew well.  At that time, the provider lowered her GH dose to 1 mg then she was off the drug.  Later, the provider noted that she had been growing quite poorly so she started on GH therapy again. Her height velocity is reported to be 6.2 cm/yr (centimeter per year).  Her pubic hair and breasts were at tanner 3.  Her pubic hair and breasts were at tanner 1. 

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient as the request is medically necessary as described 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 height, height velocity, biochemical and sometimes radiological findings. The height and height velocity 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 SD (standard deviation) below the mean; 2) height more than 1.5 SD below the mid parental height SD; 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 year 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 yr. 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 less than 10ng/ml(Nanograms per milliliter).
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported. The IGF-I was normal.

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 (Food and Drug Administration) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS (standard deviation score) 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 SD. 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. The patient is a continuing therapy patient who has benefited from the requested medication. Continuation is consistent with generally accepted standards medical practice and is therefore medically necessary.

Norditropin, 2.8 milligrams(mg) daily, 3 syringes for 28 days is considered medically necessary for this patient.

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

The insurer's denial of coverage for Norditropin, 2.8 milligrams daily, 3 syringes for 28 days is overturned. Medical Necessity is substantiated.