Diagnosis: Growth hormone deficiency
Treatment: Norditropin
The insurer denied coverage for Norditropin
The denial is overturned

This patient diagnosed with growth hormone deficiency (GHD). This request is for Norditropin 2 milligrams (mg) daily. As reported, she is on growth hormone (GH) therapy started approximately 3 years and 10 months ago. Provider states she started with 0.24 mg per kilogram (kg) per week (wk). Her GH stimulation peaked at 8.09. Her breast at left side was at tanner 2; and right side was at tanner 3. Her bone age was 2 years less than her chronological age (CA). She has a low volume of pituitary gland which may be seen in the setting of pituitary hypo stimulation or hypoplasia.

Her weight on 30.8 kg.

Her pretreatment height was 115 centimeters (cm) [-2.31 standard deviation score (SDS)] and at current age was 120 cm (-2.84 SDS) with height velocity over 2 years was 2.5 cm/year. Her height on therapy was 139 cm (-3.27 SDS). Her mid parental height is not clear in the chart.

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 standard deviations (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 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 insulin-like growth factor 1 (IGF-1) or insulin-like growth factor binding protein 3 (IGFBP-3) or GH stimulation testing with a peak GH less than 10 nanograms/ milliliter (ng/ml).

This patient met biochemical criteria. GH stimulation testing peaked at less than 10ng/ml. The patient met height criterion 3 as her height is more than 2 SD below the mean and height velocity was more than 1 SD below the mean. The patient met both height and height velocity and biochemical criteria for the diagnosis of GH deficiency. GH in the treatment of GHD is medically necessary.

The patient is a continuing therapy patient who has open growth plates and a normal height velocity on treatment. The request is consistent with generally accepted standards of medical practice. The request is medically necessary.

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

The insurer's denial of coverage for Norditropin is overturned. Medical Necessity is substantiated.