Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature

Treatment: Nutropin AQ (Somatropin)  3.5 milligrams (mg) per day for idiopathic short stature

The insurer denied coverage for Nutropin AQ 3.5 milligrams (mg) per day for idiopathic short stature

The denial is overturned

This is a young male diagnosed with Idiopathic Short Stature. This request is for Nutropin. As reported, he started on GH (growth hormone) therapy. He is currently taking 2.9 mg (milligrams) daily. His GH stimulation test with arginine and glucagon peaked at 43. His height velocity on therapy is reported to be 6.7 cm/yr (centimeters per year). His pretreatment height velocity is reported to be 5.6 cm/yr. His IGF1 (Insulin growth-like factor 1) was 62 (56-144); IGFBP3 (Insulin growth-like factor binding protein 3) was 1.7 (2.1-4.2). His weight was 36.10 kg (kilograms). 

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 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 yr. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10ng/ml (nanogram per milliliter).

The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10.

This patient met criterion 1 as pretreatment height more than 2 SD below mid-parental target height. IGF1 and IGFBP-3 were low on 2 occasions. Pretreatment height velocity was less than the 25th percentile. The patient therefore met 3 of the above criteria. The patient meets accepted criteria for the diagnosis of growth hormone deficiency. Growth hormone in the treatment of growth hormone deficiency is medically necessary.

Continuation of growth hormone is warranted, and patient has growth plate fusion or post pubertal slowing of the height velocity to less than 2 cm/year. The patient continues to grow and has open growth plates. Continuation is consistent with generally accepted standards of medical practice and is therefore medically necessary.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

Nutropin AQ 3.5 milligrams (mg) per day for idiopathic short stature is considered medically necessary for this patient.

The insurer's denial of coverage for Nutropin AQ 3.5 milligrams (mg) per day for idiopathic short stature is overturned. Medical Necessity is substantiated.