Nutropin Aq denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The parent of the enrollee has requested authorization and coverage for human growth hormone (GH) therapy with Nutropin AQ for treatment of the enrollee’s small for gestational age (SGA), poor weight gain, and short stature. Findings: The physician reviewer found that the U.S. Food and Drug Administration (FDA) has approved an indication for the use of GH therapy in patients with SGA. It is estimated that 9 out of 10 children born SGA experience rapid catch-up growth during the first 12 months of life, but 10-15% do not experience catch-up growth. The data in the medical literature indicate that GH treatment in short children born SGA is intended to achieve more normal height in early childhood, then maintain a normal height gain and reach adult height within the normal target genetic range.

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for Nutropin AQ 20 mg for treatment of the enrollee’s short stature. Findings: The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. This patient’s pre-treatment height was more than two standard deviations delayed, and his bone age was delayed for chronological age. According to the Pediatric Endocrinology Society guidelines, a trial of growth hormone therapy should be approved for children with otherwise unexplained short stature who pass growth hormone stimulation tests but who meet most of the following criteria: height more than 2.25 standard deviations below the mean for age or more than two standard deviations below the mid-parental height percentile; growth velocity less than the 25th percentile for bone age;…

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The parents of the patient requested authorization and coverage for Nutropin AQ.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. The response to GH is variable, and the predicted height is not an absolute criterion for growth hormone treatment decisions.

The patient is a 12-year-old male who has been diagnosed with short stature. According to the provided growth charts, the patient has been growing close to the 20th percentile since the age of four years old. On 10/1/18, his bone age was 11 years old at a chronological age of 11 years and three months. On 12/20/18, the records noted the patient’s mother’s height was 5’2” and the patient’s father’s height was 5’11”. On 2/1/19, the patient underwent a growth hormone (GH) stimulation test with clonidine and L-dopa, which he failed. On 2/22/19, the patient’s height was 55 inches. On 4/19/19, the patient’s height was 55 and 3/8 inches. There was no documentation provided of the patient’s testicular volume. On 3/15/19, magnetic resonance imaging (MRI) of the brain was normal. On 6/18/19, the provider noted the patient was started on GH therapy in April 2019.

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