Omnitrope denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Omnitrope. Essential diagnostic criteria for idiopathic short stature (ISS), according to the U.S. Food and Drug Administration (FDA), are a standing height z-score below -2.25 standard deviations (SDs) below the mean for age and gender in the absence of identifiable pathology. This patient’s height z-score remained well below -2.25 SDs over the past two years, prior to the initiation of growth hormone therapy. According to the patient’s growth chart, he has continuously displayed an abnormal height z-score -2.25 SDs or more below the mean, despite normal prepubertal growth velocity and no identified pathophysiology related to growth or development. Failures on at least two standard provocative tests compose one criterion to suggest pediatric growth hormone deficiency.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The parent of a patient has requested authorization and coverage for Omnitrope. Children with growth hormone deficiency are usually much shorter than their peers and over time, they tend to drop farther below the normal range. It is important to note that growth hormone-deficient children are not necessarily always below the 3rd percentile for their height; in many cases, the poor growth velocity over time is a marker of growth failure. Clinical practice guidelines on growth hormone and insulin-like growth factor 1 (IGF-1) treatment in children and adolescents recommend against reliance on growth hormone provocative test results as the sole diagnostic criterion of growth hormone deficiency. The guidelines suggest detailed individual case-based review when managing a child with short stature.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for an Omnitrope vial. Omnitrope is a form of human growth hormone (GH) used to treat growth deficiencies in children and adults who lack natural GH. Omnitrope has also been utilized for other purposes, such as adjunct therapy during in vitro fertilization (IVF) stimulation. A study on GH use for IVF concluded that, “The use of adjuvant GH in IVF treatment protocols has uncertain effect on live birth rates and mean number of oocytes retrieved in normal responders. However, it slightly increases the number of oocytes retrieved and pregnancy rates in poor responders, while there is an uncertain effect on live birth rates in this group.” Additionally, Omnitrope is not U.S. Food and Drug Administration (FDA) approved to be used for fertility treatment.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The parent of a patient has requested authorization and coverage for Omnitrope cartridges. Based on the patient’s height of 152.5 cm and contemporary bone age of 14.29 years, this patient’s predicted final adult height (FAH) is 178.7 cm ± 3.2 cm, or 70.3” ± 1.2”. This predicted FAH, as well as FAHs recently predicted by the treating pediatric endocrinologist, are within the normal range for FAHs of men (≥ 162.5 cm or ≥ 64”) and within one standard deviation (SD) of the mid-parental target height (MPTH) of 67.5” estimated by the treating pediatric endocrinologist. Essential diagnostic criteria for idiopathic short stature (ISS) according to the U.S. Food and Drug Administration (FDA) include a standing height z-score below –2.25 and the absence of identifiable pathology.

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 Omnitrope, then check the rights and deadlines that apply to your plan.