Genotropin denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The parent of a patient has requested authorization and coverage for Genotropin. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patient’s idiopathic short stature. The submitted documentation supports the medical necessity of the requested medication. The patient’s weight for height ratio is normal, and other causes of short stature have been ruled out. This patient has not undergone provocative growth hormone (GH) testing. However, the patient meets criteria for a trial of GH therapy for treatment of idiopathic short stature. The U.S. Food and Drug Administration has approved GH therapy for children with short stature who are predicted to reach an adult height of less than 63 inches in males and less than 59 inches in females.

Findings: The physician reviewer found that a patient’s parent has requested authorization and coverage for Genotropin. Growth hormone deficiency (GHD) is an uncommon cause of growth failure in which pediatric patients do not make enough growth hormone to grow normally. Growth hormone-deficient pediatric patients are not necessarily always below the third percentile for their height. In many cases, poor growth velocity is a marker of growth failure. Clinical practice guidelines on growth hormone treatment in pediatric patients recommend against reliance on growth hormone provocative test results as the sole diagnostic criterion of GHD, and suggest a detailed, individual case-based approach. In this case, the patient has a poor growth velocity of a low annual growth velocity. The patient has also failed a growth hormone stimulation test. Based on the records, the patient has GHD.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for a Genotropin 12 mg cartridge, at a quantity of five, every 33 days. On review of the current medical literature and guidelines, the requested Genotropin 12 mg cartridge, at a quantity of five every 33 days, is not medically necessary for the treatment of this patient. The essential diagnostic criteria for idiopathic short stature (ISS) according to the U.S. Food and Drug Administration (FDA) and the Pediatric Endocrine Society, are standing height z-score below -2.25 standard deviations (SDs) below the mean for age and gender and the absence of identifiable pathology. This patient’s height z-score has remained above -2.25 SDs prior to growth hormone (GH) exposure, so she has not met the diagnostic criteria for ISS.

Nature of Statutory Criteria/Case Summary: The parent of a patient has requested authorization and coverage Genotropin 1.4 mg MiniQuick pen. Findings: The physician reviewer found that Idiopathic short stature (ISS) is defined as a standing height more than 2.25 standard deviations below the population men and in the absence of identifiable pathology. The U.S. Food and Drug Administration (FDA) has approved the use of growth hormone for pediatric patients with ISS whose current height is -2.25 standard deviations from the mean. A review of the record establishes that the patient does not meet the criteria for ISS, as her most recent height score remains above -2.25 standard deviations above the mean, and possible etiologies of her short stature, including intracranial lesions, have not been excluded.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Genotropin, then check the rights and deadlines that apply to your plan.