Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature (ISS)

Treatment Nutropin AQ (Somatropin) NuSpin (device)

The insurer denied coverage for Nutropin AQ NuSpin

The denial is upheld

This is a teenage male diagnosed with idiopathic short stature (ISS). This request is for Nutropin. He was started on cyproheptadine by gastroenterology (GI) and was noted to have improved growth rate while on the medication. His growth hormone (GH) stimulation test with clonidine and arginine peaked at 11.6. His height velocity is reported to be 6.35 centimeters/year (cm/yr). The patient's testes were 8-10 cubic centimeters (cc) bilaterally and pubic hair was at Tanner lll. His Insulin Like Growth factor 1 (IGF1) level was 101; Insulin Like Growth Factor Binding Protein 3 (IGFBP3) was 3,170 (1,828-6,592). Another IGF1 was 118 (49-487 page 29); Z-score was -0.9 standard deviations (SD); IGFBP3 was 3,180 (2,134-6,598 page 30). 

The patient's height increased to 145 cm (-2.29 SDS) with a height velocity over 1.132 years of 6.5 cm/year (yr). His predicted adult height based on the bone age is 166.9 cm at the 8th percentile. 

The peer-reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:

Classic GH deficiency

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 yrs. 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 10ng/ml (nanogram per milliliter).

The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10.

The patient's most recent pretreatment height is not less than or equal to -2.25 SD and the height prediction is normal. The patient therefore does not meet idiopathic short stature criteria. The request also does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary treatment for the patient's condition.

The health care plan did act reasonably, with sound clinical judgment, and in the best interest of the patient.

The insurer's denial of coverage for coverage for Nutropin AQ NuSpin is upheld. Medical necessity is not substantiated.