Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature

Treatment: continuation of the medication Norditropin 15 mg (milligrams)/1.5 ml (milliliter) FlexPro injection pen, quantity of 22.5 every 93 days.

The insurer denied coverage for continuation of the medication Norditropin 15 mg/1.5 ml (milligram/ml) FlexPro injection pen, quantity of 22.5 every 93 days.

The denial is upheld.

This male was diagnosed with ISS (Idiopathic Short Stature). This request is for Norditropin. As reported, he is on GH (growth hormone) therapy, and his growth has already increased showing an excellent response. He is taking 2.4 mg daily. His testes were 20 cc (cubic centimeter) bilaterally with tanner 4 pubic hair. His height velocity is reported to be 9.398 cm/yr (centimeter/year). His weight was 65.204 kg (kilogram). His pretreatment height was 143.51 cm (-1.50 SDS (standard deviation score)) and is now 148.89 cm (-2.03 SDS) with height velocity over 1y5m of 3.8 cm/yr.
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, and 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 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 over 2 yr of age; 4) 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 greater than 10.

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 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 does not have a pretreatment height less than or equal to -2.25 SD. The patient, therefore, does not meet the idiopathic short stature criteria.

The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for the continuation of the medication Norditropin 15 mg/1.5 ml (milligram/ml) FlexPro injection pen, a quantity of 22.5 every 93 days is upheld. Medical Necessity is not substantiated.