Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth Hormone Deficiency; Pituitary Microadenoma, Short Stature. 
Treatment: Norditropin. 
The insurer denied the request for Norditropin. 
The health plan's determination is upheld. 

The patient is a female who is diagnosed with growth hormone deficiency (GHD). This request is for Norditropin 1.3 milligrams (mg) daily. Her growth hormone (GH) stimulation test with Arginine and Clonidine peaked at 6.36. Her height velocity is reported to be 3.8 centimeter(cm)/year (YR). Her magnetic resonance imaging (MRI) showed a small normally positioned pituitary gland.

Her Insulin-like Growth Factor 1 (IGF1) was 175 and her standardized (Z) score was -1.5 standard deviation (SD). The patient's adrenocorticotropic hormone (ACTH) was 13 and her Insulin-like growth factor binding protein 3 (IGFBP3) was 6.23. Her bone age was 10.6 years at chronological age (CA) 10 Y 6 month (M). Her breasts were at tanner 3 and her pubic was at tanner 2 early 3.

Her height at 9.82 YO was (minus (-)1.95 SDS) and at 11.36 YO she was(-1.63 SDS) with a height velocity over 1Y and 6M of 6.6 cm/YR, -1.3 SD for her stage of puberty. Her height prediction based on the bone age is -2.27 SD. Her height velocity at the endocrinologist ranged between 5.5 and 7.5 cm/year. Her height velocity over 2 years was 5.48cm/Y, 1SD. Her mother's height is 160.02 cm and father's height is 167.6 cm. The patient's mid parental height is 157.33 cm (-0.93 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 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 (YR) more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 YR in children over 2 YR of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 YR 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 10 nanograms/milliliter (ng/ml).
 
The patient did not meet height and height velocity criteria as her pretreatment height and her height velocity are normal. The 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.
Although the patient's height prediction is below the midparental target height, there are no studies showing safety or efficacy of growth hormone in patients such as this patient who had a normal height and a normal height velocity. 

The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore she 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.