Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth hormone (GH) deficiency.
Treatment: Norditropin FlexPro 15mg (milligrams)/1.5ml (milliliter) pen injector, 3.6 mg subcutaneous injection daily for 6 days for 1 year.

The insurer denied coverage for Norditropin FlexPro 15mg/1.5ml pen injector, 3.6 mg subcutaneous injection daily for 6 days for 1 year. The denial is upheld.

This is a male diagnosed with growth hormone (GH) deficiency. The patient has central precocious puberty (CPP), which is treated with Lupron. He is taking Concerta for ADHD (attention deficit hyperactivity disorder). The patient's Insulin-like growth factor (IGF1) was 195 (192-689). The Growth Hormone stimulation test with arginine and clonidine, peaked at 2.78 and 4.7 respectively. Growth Hormone (GH) therapy was commenced. His testes were 3 cm (centimeters) bilaterally and pubic hair was at early Tanner III stage. His height velocity is reported to be 8 cm (centimeters)/year. 

The patient's weight was 169 lbs (pounds). His pretreatment height was 148 cm (centimeters) (+1.37 SDS (standard deviation score)). Height on therapy was 161.29 cm (+1.72 SDS). His mid parental height is 175.26 (-0.22 SDS).

The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:

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 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 IGFBP3 (insulin-like growth factor binding protein) or GH stimulation testing with a peak GH less than 10ng (nanograms)/ml (milliliter).
		
The patient did not meet height and height velocity 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.

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 the Norditropin FlexPro 15mg/1.5ml pen injector, 3.6 mg subcutaneous injection daily for 6 days for 1 year is upheld. Medical Necessity is not substantiated.