Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth Hormone Deficiency. 
Treatment: Skytrofa. 

The insurer denied coverage for Skytrofa. 
The denial is upheld. 

This is an adolescent male diagnosed with growth hormone deficiency. This request is for Skytrofa 9.1 mg (milligram)/week. As reported, he has been receiving samples of Skytrofa and he is doing well. As per visit note, he has received 5 shots of Skytrofa 7.6 mg once a week. His growth hormone (GH) stimulation with clonidine and arginine peaked at 6.2. His magnetic resonance imaging (MRI) was normal. His height velocity on therapy is reported to be 5.6 cm/yr (centimeters per year). 

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 (standard deviation) 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 below the mean over 1 yr. or more than 1.5 SD sustained over 2 yr. The biochemical criteria include low insulin growth like factor 1 (IGF1) or (insulin growth-like factor binding protein 3) (IGFBP3) or GH stimulation testing with a peak GH less than 10ng/ml (nanogram per milliliter). 
		
The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. GH stimulation testing peaked at less than 10ng/ml. The pediatric endocrine society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing. The request is not consistent with generally accepted standards of medical practice. 

The health plan acted reasonably with sound medical judgment in the best interest of the patient. The insurer's denial of coverage for Skytrofa is upheld. Medical Necessity is not substantiated.