Appeal type: Medical necessity
Decision: Upheld

Diagnosis: growth hormone deficiency (GHD)

Treatment: Humatrope 12mg cartridge

The insurer denied coverage for Humatrope 12mg cartridge. The denial was upheld.

This patient is a female child diagnosed with growth hormone difficiency (GHD). This request is for Humatrope. Her GH stimulation test with arginine and clonidine peaked at 6.9. Her MRI ruled out any pituitary reason for her GHD. Her mother's height is 154.94 cm and father's height is 172.72 cm; mid-parental height is 157.33 cm (-0.93 SDS). In mid-2019 her IGF1 was 251 and IGFBP3 was 4.3.  Her bone age on a specified date was 12 years. Her height at 11.25 years was 137 cm (-1.23 SDS). Her pubic hair is at tanner 2 and breast at tanner 3. 

The health plan acted in the best interest of the patient as the requested growth hormone is not medically necessary as described below.

The peer reviewed literature including consensus clinical guidelines, and 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 auxological, biochemical and sometimes radiological findings. The auxological 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 deviations (sd) below the mean; 2) height more than 1.5 sd below the mid-parental height; 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 yr. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10ng/ml.
		
The patient did not meet auxological criteria as pretreatment height and height velocity are normal. 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.

Idiopathic Short stature
Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines.(4-9)  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.

Based on the above, the medical necessity for Humatrope 12mg cartridge is not substantiated.  The insurer's denial is upheld.