Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature (ISS)

Treatment: Norditropin FlexPro 10 milligram (MG)/1.5 milliliter (ML) SC (subcutaneous) SOPN (Solution Pen Injector).

The insurer denied coverage for Norditropin FlexPro 10 milligram (MG)/1.5 milliliter (ML) SC SOPN (Solution Pen Injector).

The denial is overturned

This is a female diagnosed with idiopathic short stature (ISS). This request is for Norditropin. As reported; she has a pituitary abnormality. Her Growth Hormone stimulation test with arginine and clonidine peaked at 14.2.  Her height velocity is reported to be 4.5 centimeters/yr (year). Her breasts and pubic hair were at Tanner 1. 

Classic growth hormone (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 insulin-like growth factor 1 (IGF1) or insulin growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10ng/ml (nanogram pr milliliter).
		
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]. Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height standard deviation score (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 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's predicted adult height is in a range that causes disability such as the inability to drive a car.

The insurer's denial of coverage for Norditropin FlexPro 10MG/1.5ML SC SOPN is overturned. 
The health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

The medical necessity for Norditropin FlexPro 10MG/1.5ML SC SOPN is substantiated.