Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hypopituitarism
Treatment: Genotropin
The insurer denied the Genotropin as medically unnecessary.
The health plan's determination is upheld.

The patient is a male who is diagnosed with Hypopituitarism. His growth hormone (GH) stimulation test with arginine and Clonidine peaked at 5.30 and 7.37 respectively. His bone age had a difference of 3 months from his chronological age (CA). His Insulin-like Growth Factor 1 (IGF1) was 87.
His magnetic resonance imaging (MRI) showed a 3-millimeter (mm) focus of delayed enhancement in the left bilaterally pituitary gland that is non-specific and may represent a microadenoma. His testes were 4.5 cubic centimeters (cc) on the right and 5 cc on the left. His pubic hair was at tanner 2. 
His weight was 52.3 kilograms (kg). His height was 152 centimeters (cm) (-[negative]0.88 standard deviation score (SDS)) and one year later was 156 cm (-0.88 SDS) with a height velocity over 1 year of 4 cm per year. His mid parental height is 179.2 cm (+[positive] 0.33 SDS).

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The requested service and treatment of Genotropin is not medically necessary for the patient. The peer reviewed literature including consensus clinical guidelines and 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 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 (yr) more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 yr in children that are over 2 years of age; 4) in the absence of a short stature, a height velocity more than 2 SD below the mean over 1 yr 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 10 nanograms/milliliter (ng/ml).

The patient did not meet height and height velocity criteria as his pretreatment height and height velocity are normal. His height prediction is normal. GH stimulation testing peaked at less than 10ng/ml.

Idiopathic Short stature:

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4-9]. The Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by a height SDS less than or equal to negative (-)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 does not have a pretreatment height less than or equal to -2.25 of the 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.