Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic Short Stature
Treatment: Norditropin Flexpro
The insurer denied: Norditropin Flexpro
The denial is: Upheld

This is a male diagnosed with idiopathic short stature (ISS). This request is for Norditropin. His growth hormone (GH) stimulation test with arginine and glucagon peaked at 11. His height velocity is reported to be 5.2 centimeters per year (cm/yr.). His Insulin-like Growth Factor 1 (IGF1) was 45 (44-221 mean 109); Insulin-like growth factor binding protein 3 (IGFBP3) was 1.98 (2.10-5.47).

The health plan's determination is upheld.

The Norditropin Flexpro is not medically necessary for this patient. The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below.

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

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 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 standard deviation (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 1 as pretreatment height was -2.29SD. IGFBP-3 was low. bone age was not delayed. Height velocity is not less than the 25th percentile. The patient therefore did not meet 3 of the above criteria.
Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4-9]. The patient had a pretreatment height less than or equal to -2.25 SD. The patient's height velocity is normal. A current bone age is not available. The request therefore does not meet idiopathic short stature criteria.
The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.