Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pediatric Growth Hormone Deficiency.
Treatment: Norditropin.
The insurer denied the Norditropin.
The denial is overturned.

The patient is a male with a history of posterior fossa tumor resection and radiation. The patient's height is at the 3rd percentile. He has had a poor growth velocity of 0.8 cm (centimeters), or 3.6 cm (centimeters) per year, with a very low GH (growth hormone) level after GH (growth hormone) stimulation test. He had a peak GH (growth hormone) of 0.15 ng/dL (nanograms per deciliter), and a low IGF-1 (insulin-like growth factor 1) level of 69 ng/dL (nanograms per deciliter).

Yes, the requested treatment with Norditropin is medically necessary.
This patient was diagnosed with growth hormone deficiency (GHD). Based on review of the case, the patient did meet many of the key criteria for the diagnosis of an isolated growth hormone deficiency, including the above Clinical and Radiological criteria. The patient did meet the biochemical findings for GHD (growth hormone deficiency), including failure of 2 GH (growth hormone) provocative testing with a very low GH (growth hormone) level and low IGF-1 (insulin-like growth factor 1) level. This patient also has short stature and there is clear demonstration of persistent linear growth deceleration to suspect GHD (growth hormone deficiency). Bone age is mildly delayed and patient has had brain radiation and tumor resection making him at a very high risk for GH (growth hormone) deficiency.

Tumors of the central nervous system, the most common solid tumors of childhood, are a major source of cancer-related morbidity and mortality in children. Survival rates have improved significantly following treatment for childhood brain tumors, with this growing cohort of survivors at high risk of adverse medical and late effects. Endocrine morbidities are the most prominent disorder among the spectrum of long-term conditions, with growth hormone deficiency the most common endocrinopathy noted, either from tumor location or after cranial irradiation and treatment effects on the hypothalamic/pituitary unit. Radiation is a potent cause of dysfunction in the hypotalamic pituitary unit. The hallmark features of pediatric GHD (growth hormone deficiency) are abnormally slow growth velocity with progressive decline in height z-score, often associated with delayed skeletal maturation, low levels of circulating IGF-1 (insulin-like growth factor 1) and/or IGFBP-3 (insulin-like growth factor binding protein 3), and inadequate GH (growth hormone) secretory response to pharmacologic secretagogues.

These findings are consistent with growth hormone deficiency per the above Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone (GH) Deficiency in Childhood and Adolescence by The GH (Growth Hormone) Research Society and the referenced medical literature. Therefore, the drug is being requested for a medically accepted indication as supported by current medical literature and any applicable diagnostic/treatment guidelines.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.