Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Endocrine/Metabolic/Nutritional/Short Stature
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested prescription drug, Nutropin, as not medically necessary. 
The health plan's determination is overturned.

This is a female diagnosed with idiopathic short stature (ISS). This request is for Nutropin 0.9 mg (milligrams) daily. As reported, she previously had Nutropin. She has been stable on Nutropin; she is taking 0.8 mg daily. Her growth hormone (GH) stimulation test with Arginine and Glucagon peaked at 11. Her height velocity is improved from 3.6 cm/yr (centimeters/year) to 7.69 cm/yr. Her bone age was 6 years 4 months at chronological age (CA) 6 years 11 months. Her breasts were at tanner 1. Her Insulin-like Growth Factor 1 (IGF1) was 40 (-2SD (standard deviation)). The patient 's weight was 16.3 kg (kilograms).
The patient's pretreatment height at 4.5 years old was 91 cm (centimeters) (-3.13 SDS (standard deviation score)) and at 5.34 years old was 93.7 cm (-3.70 SDS) with height velocity over 0.8 year of 3.2 cm/yr. Her height at 7.192 years old was 108 cm (-2.86 SDS). Her mother's height is 144.78 cm and father's height is 157.48 cm and mid parental height is 144.63 cm (-2.87 SDS).
At issue is the medical necessity for the requested prescription medication, Nutropin.

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

Yes. The requested health service/treatment of Nutropin is medically necessary for this patient.
The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:
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 the following:
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 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 10ng/ml (nanograms/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 was -3.7SD. IGF1 was low. 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.