Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Growth hormone deficiency (GHD).
Treatment:  Norditropin.

The insurer denied coverage for Norditropin.  The denial is upheld.

This is a female diagnosed with growth hormone deficiency (GHD). This request is for Norditropin. As reported; she is on growth hormone (GH) therapy on Norditropin, and she is taking GH therapy at dose 1.8 milligrams (mg) subcutaneous (SC) daily [0.3 mg/kilograms (kg)/week ]. Her GH stimulation test with arginine and clonidine peaked at 4.15. Her insulin like growth factor 1 (IGF1) was 213. Her breasts and pubic hair were at tanner 4. Her weight was 111.8 pounds. Her pretreatment height was 145.9 centimeters (cm) [-1.30 standard deviation score (SDS)]. Her height on therapy was 157.2 cm (-0.34 SDS). Her mother's height is 162.56 cm, and father's height is 165.1 cm, and mid parental height is 157.33 cm (-0.93 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 standard deviation (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 year 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 year. The biochemical criteria include low IGF1 or insulin like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms/milliliter, (ng/ml).
		
The patient did not meet height and height velocity criteria, as pretreatment height was normal and height velocity over 1 and 2 years is not reported. GH stimulation testing peaked at less than 10ng/ml.

The pediatric endocrine society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing.

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 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 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 care plan acted reasonably and with sound medical judgment and in the best interest of the patient.

The insurer's denial of coverage for Norditropin Flexpro 15 milligrams (mg) / 1.5 milliliter (ml) pen injector, quantity requested 6 pen injectors, days' supply 30 services is upheld. Medical Necessity is not substantiated.