Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth hormone deficiency (GHD)
Treatment: Skytrofa
The insurer denied coverage for: Skytrofa
The denial is: Upheld
This is a teenager diagnosed with growth hormone deficiency (GHD). This request is for Skytrofa. As reported the patient is on Arimidex,  Norditropin,  Genotropin.  Genotropin device and Nutropin are currently on manufacturer backorder.  Norditropin was ordered but there is a nationwide shortage.

The patient's growth hormone (GH) stimulation test with Arginine and L-dopa peaked at 8.6. The patient's magnetic resonance imaging (MRI) was normal. The patient's bone age was  2 years more  at CA (calendar age). The patient's IGFBP3 (Insulin-like growth factor-binding protein) was 4240 (2330-69650); and was 3223 (2330-6550).

The patient's height velocity is reported to be 3.166 centimeter/year (cm/yr). The patient's weight was 56.8 kilogram (kg) The patient's height was 163.6 centimeter (cm) (-0.66 Standard Deviation Scores [SDS]) and the patient was 165.9 cm (-0.76 SDS) with height velocity over 8 months of 3.5 cm/yr. The patient's predicted adult height is 165.1 cm (-1.64 SDS). The patient's mother's height is 168.275 cm and father's height is 180.34 cm and mid parental height is 180.77 cm (+0.55 SDS).

The requested medication has been shown to be safe and effective for the treatment of growth hormone deficiency(5,6). The study using the medication shows that the medication is clinically equivalent to daily injections of growth hormone in terms of efficacy and safety. The study showed a slight advantage of the Skytrofa over daily somatropin but only went for 1 year and did not show improved final height.  It has the advantage of being a weekly medication. Other than the convenience of weekly administration, the requested medication is not superior to daily growth hormone.

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 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 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 over 2 yr of age; 4) in the absence of short stature, a height velocity more than 2 SD (Standard Deviation) below the mean over 1 yr or more than 1.5 SD sustained over 2 yr. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10ng/ml.
		
The patient did not meet height and height velocity criteria. growth hormone (GH) stimulation testing peaked at less than 10 nanogram/milliliter (ng/ml). The patient's GH stimulation test with Arginine and L-dopa peaked at 8.6.

The pediatric endocrine society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing. In addition, the patient has already reached a bone age.  The patient does not meet growth hormone deficiency criteria.
The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary. The references provided are the most current/relevant to the case.

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 Skytrofa is not substantiated.