Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Endocrine/Metabolic/Nutritional. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Norditropin. 
The denial is overturned. 

This is a female diagnosed with growth hormone deficiency (GHD) and small for gestational age (SGA). Prior to initiation of growth hormone (GH) (Norditropin) her height percentile had a standard score (z-score) of less than -2.5 standard deviation (SD). She had a negative magnetic resonance imaging (MRI) scan of the brain and pituitary. Her GH stimulation test with clonidine and arginine peaked at 8.43. Her weight was 31.4 kilograms (kg).
Her pre-treatment height  was 109 centimeter (cm) (-2.46 standard deviation score (SDS)) and was 111 cm (-3.09 SDS) with height velocity over 1 year of 2 cm/year. Her mid parental height is 161.1 cm (-0.35 SDS). The height velocity taken from the growth chart on growth hormone continues to be excellent.
At issue is the medical necessity of Norditropin.

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Norditropin is medically necessary for this patient.
The peer reviewed literature including consensus clinical guidelines, and randomized controlled trials support Norditropin.  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 provided by the American Association of Clinical Endocrinologists. [4] These guidelines are the latest available from the 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 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 years 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 years. The biochemical criteria include low Insulin-like Growth Factor 1 (IGF1) or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms (ng)/milliliters (ml). 
This patient met biochemical criteria. GH stimulation testing peaked at less than 10ng/ml. The patient met height criterion as his height is more than 1.5 SD below target height SD. The patient also met auxological criterion, as the height was more than 2 SD below the mean and the height velocity was more than 1 SD below the mean before treatment. The patient met both height and height velocity and biochemical criteria for the diagnosis of GH deficiency. GH in the treatment of GH deficiency is medically necessary. In addition, the patient is continuing therapy and has benefited from growth hormone. The patient's bone age shows open growth plates. The patient's height velocity improved on growth hormone and the patient has growth potential. Continuation is consistent with generally accepted standards of medical practice.
Therefore, the requested health service/treatment of Norditropin is medically necessary for this patient.