Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pediatric Growth Hormone Deficiency.
Treatment: Norditropin.
The insurer denied the Norditropin.
The denial is overturned.

The patient is a male diagnosed with GHD (growth hormone deficiency). This request is for Norditropin 1.5 mg (milligrams) daily.

As reported, the patient is on GH (growth hormone) therapy, though there is no start date mentioned. He is on Norditropin 1 mg (milligram) daily (0.126 mg [milligrams] x kg [kilogram] x week). His GH (growth hormone) stimulation test with arginine and clonidine peaked at 9.92. His MRI (magnetic resonance imaging) showed smaller than average pituitary. His pretreatment IGF1 (insulin-like growth factor 1) was 145 (97-407); Z-score was - [minus] 2.4 SD (standard deviations).

The patient's pretreatment height was 124 cm (centimeters) and approximately two years later was 133 cm (centimeters) (- [minus] 2.07 SDS [standard deviation score]) with height velocity over 2.25 years of 4 cm/yr (centimeters per year). The patient's height on therapy was 159 cm (centimeters) (- [minus] 1.04 SDS [standard deviation score]).

The patient's mid parental height is 170 cm (centimeters) (- [minus] 0.96 SDS [standard deviation score]).

Yes, the requested Norditropin is medically necessary.
The peer-reviewed literature, including consensus clinical guidelines and randomized controlled trials, are summarized below:

Classic GH (growth hormone) deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH (growth hormone) deficiency published by the GH (growth hormone) research society (1), the Lawson Wilkins Pediatric Endocrinology Society (2, 3), and the medical guidelines for GH (growth hormone) 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 auxological, biochemical and sometimes radiological findings.

The auxological criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are:
1)	Severe short stature, defined as a height of more than 3 SD (standard deviation) below the mean;
2)	Height of more than 1.5 SD (standard deviation) below the midparental height;
3)	Height of more than 2 SD (standard deviation) below the mean, and a height velocity over one year of more than 1 SD (standard deviation) below the mean for chronological age, or a decrease in height SD (standard deviation) of more than 0.5 over one year in children over two years of age;
4)	In the absence of short stature, a height velocity of more than 2 SD (standard deviation) below the mean over one year, or more than 1.5 SD (standard deviation) sustained over two years.

The biochemical criteria include low IGF1 (insulin-like growth factor 1) or IGFBP3 (insulin-like growth factor binding protein 3) or GH (growth hormone) stimulation testing, with a peak GH (growth hormone) of less than 10 ng/ml (nanograms per milliliter).

This patient met biochemical criteria. GH (growth hormone) stimulation testing peaked at less than 10ng/ml (nanograms per milliliter). The patient met height criterion 3, as his pretreatment height is more than 2 SD (standard deviations) below the mean and height velocity was more than 1 SD (standard deviation) below the mean. The patient met both height and height velocity and biochemical criteria for the diagnosis of GH (growth hormone) deficiency. GH (growth hormone) in the treatment of GH (growth hormone) deficiency is medically necessary.

The patient is a continuing therapy patient and has benefited from growth hormone as his most recent height was - [minus] 1.04 SD (standard deviation).  Continuation of growth hormone is consistent with generally accepted standards of medical practice and is therefore medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient, as the request is medically necessary as described above.