Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Endocrine/Metabolic/Nutritional/Growth Hormone Deficiency. 
Treatment: Pharmacy/Prescription Drugs. 

The health plan denied the requested medication as not medically necessary. 
The health plan's determination is upheld. 

This is a female diagnosed with growth hormone deficiency (GHD). This request is for Zomacton. As reported, she was started on the plan preferred Zomacton. Zomacton became unavailable by the manufacturer, and she was changed to Norditropin. She is taking 1.4 mg (milligram) 6 days per week (0.29 mg/kg/wk (milligram/kilogram/week)). She was on Lupron 15 mg nightly. The patient has been responding very well to the medication, growing 8.75 cm (centimeters) over the last 8 months.  Her growth hormone (GH) stimulation test with Arginine and Clonidine peaked at 8.14. Her breasts were at tanner 4 and pubic hair was at tanner 2. Her Insulin-like growth factor binding protein 3 (IGFBP3) was 5260 (2072-5504); Insulin-like Growth Factor 1 (IGF1) was 227 (49-451); Z-score was +0.5 SD (standard deviation). On a later date her IGFBP3 was 5190 (2072-5504); IGF1 was 191 (49-451); Z-score was +0.5 SD. On a later date, her IGF1 was 181 (49-451); Z-score was +0.1 SD. Her weight was 29.2 kg (kilograms).
The patient's pretreatment height was 122 cm (-1.67 SDS (standard deviation score) pretreatment height velocity is not reported. Height velocity prior to treatment taken from the growth chart appears normal. Her height on therapy was 130.9 cm (-0.99 SDS). Her mother's height is 151.765 cm and father's height is 167.64 cm and mid parental height is 153.20 cm (-1.56 SDS). 

At issue is the medical necessity for the requested medication, Zomacton. 

The health plan's determination of medical necessity is upheld, in whole. 

No. The peer reviewed literature, including consensus clinical guidelines, randomized controlled trials are summarized below: 

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 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 year 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 year. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10ng/ml (nanograms/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 does not meet any nationally accepted criteria for the use of growth hormone. The request is therefore not medically necessary.