Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature.
Treatment: Norditropin FlexPro 15 milligrams (mg)/ 1.5 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN).

The insurer denied coverage for Norditropin FlexPro 15 milligrams (mg)/ 1.5 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN).
The denial is overturned.

This is a male diagnosed with growth hormone deficiency (GHD). This request is for Norditropin. He had previous insurance coverage under idiopathic short stature (ISS) indication; he was started on 1 mg daily; his current dose is 1.9 mg/day (milligram per day) (0.28 mg/kg/wk) [milligram per kilogram per week]. His GH (Growth Hormone) stimulation test peaked at 0.3. His height velocity is improved from 4.8 centimeters per year (cm/yr) to 9 cm/yr. 

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 (yr) more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 yr in children) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 yr 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 (nanogram per milliliter).
	
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at less than 10 but with only one test. 

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]. United States 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 is continuing therapy for idiopathic short stature. The standard of care for continuation of therapy for idiopathic short stature is to continue treatment as long as the patient is growing at a rate greater than 2 cm per year and that the bone age does not show growth plate fusion. The patient is continuing to grow at 9 cm per year and that most recent bone age shows open growth plates. 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 in the best interest of the patient.

The insurer's denial of coverage for Norditropin FlexPro 15 milligrams (mg)/ 1.5 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN) to treat idiopathic short stature (ISS) is overturned. Medical Necessity is substantiated.