Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Short stature
Treatment: Omnitrope
The insurer denied coverage for Omnitrope.
The denial is overturned.

This is a child diagnosed with short stature. This request is for Omnitrope. His growth hormone (GH) stimulation test with arginine and glucagon peaked at 11. His insulin like growth factor 1 (IGF1) was 45 (44-211 mean 109; page 15); insulin like growth factor binding protein 3 (IGFBP3) was 1.98 (2.10-5.47; page 17). Several years earlier his IGF1 was 25 (20-141); his height velocity is reported to be 5 centimeters per year (cm/yr) and he was at Tanner 1. 

His weight was 17.8 kilograms (kg). His height was 106.4 cm [-2.39 (standard deviation)SD]. His mid parental height is 174.1 cm (-0.24 SDS).

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 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 years 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 IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10 nanograms per milliliter (ng/ml).
		
The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10. 

Alternate GH deficiency criteria

In addition, GH is indicated for the treatment of GH deficiency in certain patients who do not fail GH stimulation tests based on the Lawson Wilkins Pediatric Endocrine Society (LWPES) alternate criteria [2] which state, "No gold standard exists for the diagnosis of growth hormone deficiency (GHD). Although children severely affected by GHD fail GH stimulation tests, there is no doubt that some children with growth hormone deficiency (GHD) achieve stimulated GH concentrations above the arbitrary cutoffs that have been applied. A trial of GH therapy should be approved for children with otherwise unexplained short stature who pass GH stimulation tests, but who meet most of the following criteria: (1) height greater than 2.25 SD below the mean for age or  greater than 2 SD below the mid parental height percentile; (2) growth velocity less than 25th percentile for bone age;(3) bone age greater than 2 SD below the mean for age; (4) low serum insulin-like growth factor 1 (IGF-I) and/or insulin-like growth factor binding protein 3 (IGFBP3); and/or (5) other clinical features suggestive of GHD."

This patient met criterion as pretreatment height was -2.39SD. IGFBP3 was low. Height velocity is less than the 25th percentile. The patient therefore met three of the above criteria. The patient meets accepted criteria for the diagnosis of growth hormone deficiency. Growth hormone in the treatment of growth hormone deficiency is medically necessary.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Omnitrope 10 milligrams (mg)/1.5 milliliter (ml) cartridge is substantiated.