Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic short stature (ISS)
Treatment: Norditropin flexpro 15 milligrams/1.5 milliliter (mg/ml) pen injector, 1.2mg once daily by subcutaneous injection
The insurer denied coverage for Norditropin flexpro 15 milligrams/1.5 milliliter (mg/ml) pen injector, 1.2mg once daily by subcutaneous injection.  
The denial is upheld.

As reported, the patient was started on growth hormone (GH) therapy and height velocity is improved from 2.6 cm (centimeters)/yr (year) to 11 cm/yr. His GH stimulation test peaked at 17.

His pretreatment IGf1 (Insulin Like Growth Factor 1) was 155; IGFBP3 (insulin-like growth factor binding protein) was 4.95. His testes were 2-3 ml (milliliters) bilaterally and pubic hair was at Tanner 1, with weight of 36 kgs (kilograms).

Pretreatment height was 127 cm (-1.77 SDS (standard deviation score)) with height velocity over 1y (year) of 5 cm/yr. His height on therapy was 138.4 cm (-1.30 SDS). His mother's height is 157.48 cm and father's height is 167.64 cm and mid parental height is 169.06 cm (-1.09 SDS).

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 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 or IGFBP3 or GH stimulation testing with a peak GH less than 10ng (nanogram)/ml.
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10. 

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4-9]. 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."[10-13]

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

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

The insurer's denial of coverage for the Norditropin flexpro 15mg/1.5ml pen injector, 1.2mg once daily by subcutaneous injection is upheld. Medical Necessity is not substantiated.