Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Growth Failure.
Treatment: Nutropin AQ Nuspin.
The health plan denied the requested prescription medication, Nutropin AQ Nuspin as not medically necessary. 
The health plan's determination is upheld.

This is a male diagnosed with short stature. This request is for Nutropin AQ Nuspin. His growth hormone (GH) stimulation test with Arginine and Clonidine peaked at 14.9. His genetic testing was negative. Pubic hair was at tanner 1. His weight was 30.4 kilograms (kg). His height one year ago was 121 centimeter (cm) (-2.79 standard deviation score (SDS)) and one and half year later was 131.3 cm (-2.26 SDS) with height velocity over 1.7 year of 6.1 centimeter/year (cm/yr). His mother's height is 160.02 centimeter (cm), and father's height is 167.64 cm and mid parental height is 170.3 cm (-0.91 SDS).

At issue is the medical necessity for the requested health service/treatment of Nutropin AQ Nuspin. The health plan's determination of medical necessity is upheld, as the request is not medically necessary.

The requested health service/treatment of Nutropin AQ Nuspin is not medically necessary for this patient.

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

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 deviation (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 Growth Hormone (GH) stimulation testing with a peak GH less than 10 nanograms/milliliter (ng/ml).

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 allow the patient to reach a normal adult height. The patient therefore does not meet idiopathic short stature criteria.

The request does not meet any nationally accepted criteria for use of growth hormones. The request is, therefore, not medically necessary.