Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Endocrine/Metabolic/Nutritional/Pituitary Condition
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested medication as not medically necessary. 
The health plan's determination is upheld.

This patient is a male diagnosed with growth hormone deficiency (GHD). This request is for Humatrope. His growth hormone (GH) stimulation test with Clonidine and Glucagon peaked at 7.4. His genitourinary (GU) and pubic hair status was at tanner 4. There was no Insulin-like Growth Factor 1 (IGF1).
His height  was 163 centimeter (cm) (-.89 standard deviation score (SDS)) and was 164 cm (-1.00 SDS) with a height velocity over 0.42 years of 2.4 cm/year. His mid parental height was at 179.07 (+0.31 SDS).
At issue is the medical necessity of the requested medication, Humatrope.

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

No. The request is not medically necessary.
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 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 IGF1 or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10ng/ml (nanograms per milliter).
The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. GH stimulation testing peaked at less than 10ng/ml.
The Pediatric Endocrine Society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing.
Idiopathic Short Stature:
Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4, 5, 6, 7, 8, 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."
The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet idiopathic short stature criteria.
The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.