Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature. 

Treatment: Norditropin Flexpro 10 milligrams (mg) per 1.5 milliliter (ml) for date yet to be determined and filled at a network specialty pharmacy. 

The insurer denied coverage for Norditropin Flexpro 10 milligrams (mg) per 1.5 milliliter (ml) for date yet to be determined and filled at a network specialty pharmacy. 

The denial is upheld. 

This is a female diagnosed with ISS (Idiopathic short stature). This request is for Norditropin 1.25 mg 7 days (0.33 mg/kg). As reported, she was diagnosed with Celiac at an early age. She started on GH (Growth Hormone) therapy with height velocity of 9 cm/yr. Her GH stimulation test with arginine and clonidine peaked at 15.08. Her pretreatment height velocity is reported to be 3.45 cm/yr (centimeters per year). 

The health plan acted reasonably as the request is not medically necessary as described below. 

The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized 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 yr (year) 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 (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 allow the patient to reach a normal adult height. The request therefore does not meet 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 medication Norditropin Flexpro 10 milligrams per 1.5 milliliter for date yet to be determined and filled at a network specialty pharmacy is upheld. Medical Necessity is not substantiated.