Physician Frustrations and the ‘Economics’ of Growth Hormone Therapy Prior-Authorization Requests and Their Denial by Insurance Payers

Abstract

Growth hormone has been approved by the Food and Drug Administration (FDA) for treating short children with growth failure due to a variety of causes, including growth hormone deficiency (GHD), Turner Syndrome, Prader-Willi Syndrome, idiopathic short stature (ISS), chronic renal insufficiency and children born small for gestational age (SGA) with inadequate growth by their second birthday.  Children with GHD tend to be the largest proportion of short children with growth failure.  Growth hormone has a very short half-life in serum with a pulsatile pattern of release, like most pituitary hormones.  A random blood draw for growth hormone is thus impractical as a means of diagnosing GHD. The diagnosis of GHD must be established usually by performing a growth hormone stimulation test.  This is done by ‘provocation’ with pharmacological agents that cause the anterior pituitary to release stored growth hormone.  The conventional cut off for diagnosing GHD under testing conditions is currently 5 micrograms/dL for adults and 10 micrograms/dL for children.  Generally, growing children secrete higher levels of growth hormone than do adults, and thus would have higher serum levels under physiological conditions.  Endocrinologists utilize various agents for the provocative tests; these include arginine, levodopa, clonidine, glucagon and insulin.  Insulin is considered the ‘gold standard’ for growth hormone provocation tests though it is the least utilized, because of the associated danger of hypoglycemia and the need for the presence of qualified staff throughout the testing procedure to monitor and prevent such a complication.