Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short stature (ISS)

Treatment: norditropin 10 milligrams (mg) / 1.5 milliliter (ml) injection

The insurer denied coverage for a norditropin 10 milligrams (mg) / 1.5 milliliter (ml) injection
 
The denial is upheld.

This patient was diagnosed with ISS. This request is for Norditropin. As reported; she has ADHD (attention deficit hyperactivity disorder); anxiety; and OCD (obsessive compulsive disorder). She is on GH (growth hormone) therapy Omnitrope and she is using 2.1 mg (milligrams) daily. She has had menarche and her menses are still regular. Her GH stimulation test with arginine and L-dopa peaked at 20.85 and 9.22 respectively. Her height velocity is reported to be 3.9 cm (centimeters)/yr (year). Her breasts were at tanner 4. Her IGFBP3 (insulin-like growth factor binding protein) was 8.1. Her IGF1 (insulin-like growth factor 1) was 426. Her weight was 42.91 (kilograms). Her pretreatment height was 145 cm (-1.12 SDS (standard deviation score)). Her height on therapy was 151.4 cm (-1.16 SDS)

Her mother's height is 161.29 cm and her father's height is 181.61. The mid parental height is 164.95 cm (+0.25 SDS). 

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient as the request is not medically necessary as described 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) a height more than 1.5 SD below the mid parental height SD; 3) a 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 (years). The biochemical criteria include low IGF1, IGFBP3, or a GH stimulation testing with a peak GH less than 10ng (nanograms)/ml.
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10. 

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. There are no studies showing safety and efficacy of growth hormone in patients with an abnormal predicted adult height because of an advanced bone age if they have a normal pretreatment height such as this patient. The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.

The insurer's denial of coverage for a norditropin 10 milligrams (mg) / 1.5 milliliter (ml) injection is upheld. Medical Necessity is not substantiated.