Somatropin denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for somatropin 1.5 mg. Based on the policy criteria, the GH is not medically necessary for a diagnosis of GH deficiency because the patient passed the GH stimulation test and had a peak of GH of greater than 10 ng/mL. However, the patient meets the criteria for GH therapy based on the criteria for GH treatment that require given his short stature is below standard deviations below the mean. Moreover, the patient’s condition is consistent with idiopathic short stature, which is known to be responsive to GH therapy and it is very likely he has some underlying genetic defect given the extreme short stature of his mother. In addition, based on practice clinical guidelines by the Pediatric Endocrine Society and based on U.S.

The parent of a 15-year-old male enrollee has requested for continued Nutropin growth hormone therapy for treatment of the enrollee’s stated short stature/growth failure. Findings: The physician reviewer found that the recorded height nears 5’4”. Growth hormone deficiency and celiac disease has been excluded. The mid-parental height was above the 25th percentile. The projected adult height at 13 years 4 months was below the 3rd percentile, and he had a subnormal rate of growth. He was placed on growth hormone therapy and has had an excellent response. The patient’s excellent growth response indicates the benefits of continuing growth hormone therapy.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient is a 14-year-old male who has been diagnosed with short stature. On 7/14/17, his height was 136.4 cm, which was -1.7 cm standard deviations below the mean, as extrapolated by the expert reviewer using standard pediatric growth charts, placing him in the fourth percentile. On 11/20/17, the patient’s height was noted to be in the third percentile. A growth chart was not provided with the heights of the patient prior to initiation of growth hormone (GH). Treatment with somatropin was initiated sometime between July 2017 and November 2017. On 9/12/18, the patient’s height had increased from the third percentile to the tenth percentile, with a height of 149 cm. On 3/15/19, the patient’s height was 153.9 cm. His bone age was reported to be 13 years and six months at the chronological age of 13 years and seven months.

Nature of Statutory Criteria/Case Summary: An enrollee’s parent has requested authorization and coverage for Nutropin AQ Nuspin injector (somatropin) subcutaneous daily injections. The U.S. Food and Drug Administration (FDA) defines idiopathic short stature (ISS) as a height z-score at or more than –2.25 standard deviations (SDs) in the absence of an identifiable pathology. Standard pediatric endocrine care for suspected growth disorders includes taking direct height measurements of both biologic parents as self-reported parental heights may be significantly unreliable. In this case, the records document height z-scores within –2.25 SDs, normal growth velocity, unremarkable laboratory results, and normal bone age since approximately age four-and-a-half years old, prior to the administration of growth hormone.

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