Growth Horm Def denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: The patient is a nine-year-old female with a long history of growth delay. She has been diagnosed with Noonan’s syndrome. She has been treated with growth hormone therapy since September 2003 with marked improvement in her growth, and her physician has recommended further treatment with growth hormone therapy. The Health Plan has denied authorization and coverage for growth hormone therapy on the basis it is considered experimental for treatment of the patient’s medical condition. Most academic centers in the United States use growth hormone for treatment of patients with Noonan’s syndrome. In the case of this patient, there is potential for ultimate short stature. The patient has had a very positive response to initial growth hormone therapy. Use of growth hormone for treatment of patients such as this patient is standard of care in the national community.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Skytrofa. The U.S. Food and Drug Administration (FDA) approves the use of lonapegsomatropin (Skytrofa), a depot formulation of growth hormone (GH) administered weekly, to treat pediatric GH deficiency. Researchers report that treatment with weekly lonapegsomatropin is non-inferior to daily somatotropin with respect to safety and efficacy for the treatment of GH deficiency. The authors concluded that children treated with once-weekly lonapegsomatropin showed continued improvement of height standard deviations (SD) scores through the second year of therapy without excess advancement of bone age.

Where the denial was upheld

The patient is a 14-year-old male who has been diagnosed with neurosecretory defect or functional growth hormone deficiency. He has continued to drop percentages over several years from the 25th percentile to the 10th percentile with his growth velocity below the 3rd percentile for his age and gender. His parents report that based on observations over a 15-month period in addition to a low IGF-1 level and IGFBP3 level, his physician indicates the patient’s height percentiles will continue to drop. Therefore, growth hormone therapy has been recommended. The Health Plan has determined growth hormone therapy is not medically necessary for treatment of the patient’s medical condition.This patient was seen for short stature by a pediatric endocrinologist in December 2003.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The provider requested authorization and coverage for Nutropin AQ Nuspin 20 solution pen for the treatment of idiopathic short stature (ISS).Growth hormone (GH) therapy has been shown to be effective in improving the final adult height in children with idiopathic short stature (ISS). The U.S. Food and Drug Administration (FDA) approved GH therapy treatment for the treatment of ISS in 2003. The National Institutes of Health defines ISS as a height below – 2 standard deviations (SD) on a growth curve that correlates with age and sex. Treatment with growth hormone has been approved for ISS children shorter than the – 2.25 SD who have open growth plates and no other underlying condition.

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 growth horm def, then check the rights and deadlines that apply to your plan.