Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature (ISS). 
Treatment: Norditropin Flexpro 15 milligrams (mg)/1.5. 

The insurer denied coverage for Norditropin Flexpro 15 mg/1.5. 

The denial is upheld. 

This is a male diagnosed with Idiopathic Short Stature (ISS).  This request is for Norditropin.  As reported; he started Norditropin via manufactures samples and had grown 1.3 centimeter (cm) in 2 months.  His height jumped from the 2nd percentile to 5th percentile since starting the growth hormone (GH).  His GH stimulation test with arginine and clonidine peaked at 14.  His insulin-like growth factor-1 (IGF-1) was 289; Z-score was -0.84 SD [standard deviations]; insulin-like growth factor binding protein (IGFBP)-3 was 6.4. His bone age was a teen at chronological age (CA).  Recently, his testes were 14-16 cubic centimeters (cc) bilaterally and pubic hair was at tanner 3-4.  His height velocity on therapy is reported to be 8.4 cm[centimeters]/year.  His weight was 107.2 pounds (lbs). 

His pre-treatment height was 152.4 cm (-1.92 SDS [standard deviation score]) and on a year older he was 157.607 cm (-1.72 SDS) with height velocity over 7 months of 8.1 cm/year.   Another height on therapy was 160.299 cm (-1.57 SDS).  His mother's height is 162.56 cm and father's height is 170.18 cm and mid-parental height is 172.87 cm (-0.56 SDS). 

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

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 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 more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year in children over 2 years of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 year or more than 1.5 SD sustained over 2 years. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10ng/ml[nanograms 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 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 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 Norditropin Flexpro 15 mg/1.5 is upheld. Medical Necessity is not substantiated.