Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Growth Hormone Deficiency (GHD).  

Treatment:  Humatrope (Somatropin) 12 milligram cartridge

The insurer has denied coverage for Humatrope (Somatropin) 12 milligram cartridge.  The denial was upheld.

This is a male diagnosed with growth hormone deficiency (GHD).  This request is for Humatrope.  His Growth Hormone (GH) stimulation test in mid-2019 with arginine and L-dopa peaked at 8.38 and 3.64 respectively.  His height in late 2018 was 141.60 cm (-1.47 SDS) and in mid-2019 was 147.2 cm (-1.18 standard deviations (SD)) with height velocity over 6 months of 9.7 cm/yr.  His mother's height is 177.8 cm, and father's height is 175.26 cm, so mid-parental height is 183.03 cm (-0.87 SD).  His MRI was normal.  In mid-2019 his testes are 8 cc bilaterally with tanner 3 and pubic hair is at tanner 3.  In late 2018 his IGF1 was 181 and IGFBP3 was 4.9. 

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 auxological, biochemical and sometimes radiological findings.  The auxological 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; 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 10ng/ml.
		
This patient met biochemical criteria.  GH stimulation testing peaked at less than 10ng/ml.

The patient did not meet auxological criteria as pre-treatment height and height velocity are normal.

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(4-9).   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 pre-treatment 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.

The carrier's denial of coverage for Humatrope (Somatropin) 12 milligrams cartridge for the diagnosis E 23.0 is upheld.  The medical necessity is not substantiated.