Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth Hormone Deficiency
Treatment: Genotropin
The insurer denied: Genotropin
The denial is upheld.

The patient is a school aged male. He is followed by his pediatric endocrinologist for short stature. The patient's growth chart shows that his height has been tracking close to the 10th percentile for 3 years. His height last year was 121.1 centimeters. Seven months ago, his height was 123.4 centimeters, with height velocity of 2.8 centimeters per year. Four months ago, the patient's height was 124.2 centimeters, with a growth velocity of 3 centimeter per year. His midparental height is at the 10th-25th percentile. The patient's bone age was read as closest to the 9-year standard at chronological age of couple months younger. The bone age x-ray was read as closer to the standard by his 
endocrinologist. Three months ago, the patient's IGF-1 (insulin-like growth factor 1) was normal at 92 (normal 62-347), as well as IGFBP-3 (insulin-like growth factor binding protein 3) at 2.6 (normal 1.6-6.5). Five months ago, the patient underwent growth hormone (GH) stimulation testing using Arginine and Clonidine, which he failed with peak GH (growth hormone) of 7.66.
The patient's head MRI (magnetic resonance imaging) showed normal pituitary gland. The patient's endocrinologist is prescribing Genotropin. Coverage was denied by the health plan for not meeting criteria (height not greater than (>) 2 standard deviations below mean for age and gender). The appeal letter from the patient's endocrinologist points out that the patient's height is currently at 1.38 standard deviation below mean for age and gender, and that he is 18 inches away from his midparental height.

The requested Genotropin is not medically necessary.

The use of growth hormone therapy is considered medically necessary if the criteria for growth hormone therapy is met.
Per the Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone Deficiency (GHD) in Childhood and Adolescence by The GH Research Society (reference #1): Diagnosing GHD requires a multifaceted process including comprehensive clinical and auxological assessment, combined with biochemical tests of the GH-insulin-like growth factor (IGF) axis and sometimes radiological evaluation which includes:
1. Clinical and Auxological Criteria: Criteria to initiate immediate investigation include:
1) Severe short stature, defined as a height more than 3 SD (standard deviation) below the mean;
2) Height more than 1.5 standard deviations below the mid-parental height;
3) Height more than 2 standard deviations below the mean and a height velocity over 1 year more than 1 standard deviation below the mean for chronological age, or a decrease in height standard deviation 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 standard deviations below the mean over 1 year or more than 1.5 standard deviations sustained over 2 years; this may occur in 
GHD (growth hormone deficiency), presenting in infancy, or in organic acquired GHD (growth hormone deficiency);
5) Signs indicative of an intracranial lesion;
6) Signs of multiple pituitary hormone deficiency (MPHD); and
7) Neonatal symptoms and signs of GHD (growth hormone deficiency).
2. Biochemical Assessment of GHD (growth hormone deficiency):
1) A combination of 2 provocative growth hormone (GH) testing can be used to test for GHD (growth hormone deficiency) and failing both tests has traditionally been used to support the 
diagnosis. An IGF-1 (insulin-like growth factor 1) value less than -2 SD (standard deviations) suggests an abnormality in the GH (growth hormone) axis.
3. Radiological Evaluation:
1) Showing evidence of delayed bone age or abnormal pituitary gland. 
This patient was diagnosed with growth hormone deficiency (GHD). Based submitted medical records, the patient did not meet many of the key criteria for the diagnosis of an isolated growth hormone deficiency, including the above clinical criteria, and some biochemical and radiological criteria. This patient has no significant short stature, and there is no clear demonstration of persistent linear growth deceleration to suspect GHD (growth hormone deficiency). His pretreatment height is appropriate for his midparental height percentile. His serum IGF-1 (insulin-like growth factor 1) level, which is a good surrogate marker of GH (growth hormone) status, was noted to be normal despite an attenuated peak GH (growth hormone) response to provocative tests. GH (growth hormone) provocative test is not recommended as the sole diagnostic criterion of GHD (growth hormone deficiency). As known in the medical community, GH (growth hormone) stimulation testing has a number of limitations: The tests are non-physiological, the cutoff level of "normal" is arbitrary, marked variability in GH (growth hormone) assay and lack of reproducibility of GH stimulation tests. The patient's bone age and brain MRI (magnetic resonance imaging) were normal. These findings are not consistent with growth hormone deficiency per the above Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone (GH) Deficiency in Childhood and Adolescence by The GH (growth hormone) Research Society and the referenced medical literature. Therefore, the drug is not being requested for a medically accepted indication as supported by current medical literature and it is not medically necessary.