Norditropin Flexpro denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/ Case Summary: The enrollee’s parent is requesting authorization and coverage for the medication, Norditropin Flexpro. The enrollee has severe short stature, poor growth velocity and a three-year delay in bone maturation. The pediatric endocrinology office note indicates the enrollee’s magnetic resonance imaging (MRI) revealed a seven millimeter anterior intrasellar lesion. Pituitary function testing was performed twice and was normal. Neurosurgery recommended a follow-up MRI in six to eight weeks. The plan was to start growth hormone (GH) if the lesion was stable. The repeat MRI showed no change. The enrollee’s height was documented as 112.5 centimeters; less than the first percentile, and her weight was 23.8 kg, placing her in the 13th percentile. Her bone age was five years, nine months at a chronological age of eight years, seven months.

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

Nature of Statutory Criteria/Case Summary: A female enrollee has requested authorization and coverage for Norditropin FlexPro 10 mg injections for treatment of the enrollee who has a history of nontoxic multinodular goiter, gastric ulcer and obesity.Findings: The physician reviewer found that growth hormone deficiency (GHD) is a medical condition in which the body does not produce enough growth hormone (GH). Recognized effects include reduced muscle mass and strength, reduced bone strength and osteoporosis, decreased energy levels, impaired concentration and loss of memory, increased body fat, lipid abnormalities, and insulin resistance. Growth hormone deficiency is also appreciated to be a factor in this increased mortality from cardiovascular disease. GH replacement therapy can provide a number of measurable benefits to GH deficient adults.

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for the medication Norditropin FlexPro.According to the U.S. Food and Drug Administration (FDA), essential diagnostic criteria for idiopathic short stature (ISS) are a standing height z-score below –2.25 and the absence of identifiable pathology. The patient has met the essential FDA-approved standing height criteria for ISS, as his height z-score has remained well below –2.25 for over a year in the absence of puberty. However, possible genetic etiologies, such as SHOX mutation, have not been excluded. Furthermore, the submitted documentation reflects that the patient has not had brain MRI (with and without contrast). Brain MRI (with and without gadolinium contrast) obtained before the initiation of somatotropin would exclude identifiable intracranial 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 Norditropin Flexpro, then check the rights and deadlines that apply to your plan.