Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic short stature

Treatment: Nutropin AQ NuSpin 20 20 milligrams (mg) / 2 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN)

The insurer denied coverage for Nutropin AQ NuSpin 20 20 mg/ 2 ml SC SOPN

The denial is overturned

This is a child diagnosed with short stature. This request is for Nutropin AQ 20. The Growth Hormone stimulation test peaked at 10.10. The height velocity is reported to be 3.3 centimeters per year (cm/year). The bone age was 9 years/ 1 month (provider 8 years) at chronological age (CA) 9 years/ 3 months. The insulin-like growth factor 1 (IGF1) was 117; Z-score was -1.1 standard deviation (SD); insulin-like growth factor binding protein 3 (IGFBP3) was 5670. The weight was 25.7 kilograms, height was 120 centimeters (cm) [-2.42 standard deviation score (SDS)].

The mother's height is 154.94 cm and father's height is 163.83 cm and mid parental height is 168.885 cm (-1.11 SDS). The predicated adult height is 157.48 cm (-2.69 SDS).

The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:

Classic Growth Hormone (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 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 IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10 Nanograms per milliliter.

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

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines. [4-9] Food and Drug administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means". [10-13]

The patient had a pretreatment height less than or equal to -2.25 SD. The patient's height velocity and bone age would not allow the patient to reach a normal adult height. The request therefore meets idiopathic short stature criteria.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Nutropin AQ NuSpin 20 20 milligrams (mg) / 2 milliliter (ml) subcutaneous (SC) solution pen injector (SOPN) is substantiated.