Growth Hormone Deficiency denials in California external review

What the reviewers wrote

Where the denial was overturned

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.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Norditropin Flexpro. Norditropin is safe and effective for the treatment of pediatric growth hormone deficiency (GHD) and idiopathic short stature (ISS). According to the U.S. Food and Drug Administration and the Pediatric Endocrine Society, the essential diagnostic criteria for ISS are a standing height z-score below -2.25 and the absence of an identifiable pathology prior to growth hormone treatment. In this case, the records confirm that the patient’s height z-score has remained above -2.25 since birth.

Where the denial was upheld

This patient is a 37-year-old male who was evaluated in October 2004. He presents with symptoms of fatigue, decreased libido, inability to lose weight, joint pain and difficulty concentrating. The patient was felt to have hypogonadism. His baseline testosterone level in November 2004 was 284 (350-1030); free testosterone 58 (52-280); percent free testosterone (dialysis) 2.2% (1.5-3.2%); sex hormone binding globulin 0.2 (0.5-1.5); and LH-level 3.6 (1.5-9). He has been treated with Androgel 1% since the initial evaluation. Several subsequent testosterone evaluations have been performed and there has been no marked increase despite treatment with Androgel. The percent free testosterone levels remained normal and the sex hormone binding globulin remained low.

Nature of Statutory Criteria/ Case Summary: The enrollee’s parent is requesting authorization and coverage for the medication, Nutropin AQ NuSpin. The enrollee has type 1 diabetes mellitus and poor growth. His growth velocity is below normal. His current height places him in the tenth percentile. His endocrinologist placed him on growth hormone (GH) therapy and indicates the enrollee’s growth velocity is 2.76 centimeters over a nine month span, which is below the tenth percentile for growth velocity for gender, age and pubertal status. Insulin-like growth factor (IGF-1) level is greater than -2 standard deviation scores (SDS) from the mean for age and pubertal status, which is low. He has a current height on the tenth percentile, while his midparental height (MPH) is 6’2” or 97th percentile. He has a final height prediction of 68.5 inches, which is greater than 2 SDS below his MPH.

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