Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth hormone deficiency. 

Treatment: Genotropin 1.2mg injections. 

The insurer denied coverage for Genotropin 1.2mg injections. 

The denial is upheld. 

This is a patient diagnosed with Growth Hormone Deficiency (GHD). This request is for Genotropin 1.2 milligrams (mg) daily. This patient's growth hormone (GH) stimulation test with arginine and clonidine peaked at 1.87 and 2.90 respectively. The patient's bone age was 11 years at calculated age (CA) 11 years 7 months. The patient's insulin-like growth factor 1 (IGF1) was 137; Z-score was -1.3 standard deviation (SD). The patient's IGF1 was 147 (123-497 page 25); Z-score was -1.4 SD. On 10-10-2022 the patient's IGF1 was 137 (123-497 page 25); Z-score was -1.6 SD.  The patient's height velocity is reported to be 1.8 centimeter per year (cm/yr). The patient's magnetic resonance imaging (MRI) was normal. 

The patient's height at 11.758 years old was 135.5 centimeters (cm) (-1.57 SDS) and at 12.13 years old was 136.5 cm (-1.83 SDS) with height velocity over 6 months that is slow.  The patient's mother's height is 152.4 cm and father's height is 177.8 cm; mid parental height is 171.6 cm (-0.73 SDS).  The patient's predicted adult height is 167.64 cm (-1.28 SDS). 

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 patient did not meet height and height velocity criteria as pretreatment height is normal and height velocity over 1 and 2 years is not reported. Growth factors are normal. GH stimulation testing peaked at less than 10ng/ml (nanograms/milliliter). 

The pediatric endocrine society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing. 

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4-9]. U.S. (United States) 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 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. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Genotropin 1.2mg injections is not substantiated.