Nutropin 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 Nutropin pen-injector. Growth hormone (GH) therapy has been shown to be effective in improving the final adult height in pediatric patients diagnosed with idiopathic short stature (ISS). ISS is defined as a height below -2 standard deviations (SD) on a growth curve that correlates with age and sex. The U.S. Food and Drug Administration (FDA) has approved GH therapy for the treatment of pediatric patients with ISS. Treatment with GH therapy is indicated for patients with ISS who are shorter than -2.25 SD, have open growth plates, and have no other underlying condition. Notably, GH therapy has been shown to be beneficial in the final height outcome of pediatric patients with ISS, even when treatment is started late.

Nature of Statutory Criteria/Case Summary: The parent of a patient has requested authorization and coverage for Nutropin. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patient’s idiopathic short stature. The submitted documentation supports the medical necessity of the requested medication. The patient’s height is more than standard deviations below the mean the patient’s for age and gender, insulin-like growth factors -1 level is low, growth velocity is poor, and adult predicted height is less than 63 inches. Although the patient had normal results on provocative GH testing, the patient meets generally accepted criteria established by the Pediatric Endocrinology Society and the U.S. Food and Drug Administration for treatment of idiopathic short stature.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient’s parents have requested authorization and coverage for Nutropin. Essential diagnostic criteria for idiopathic short stature (ISS) are standing height Z score below –2.25 standard deviations (SDs) below the mean and the absence of identifiable pathology prior to growth hormone (GH) treatment. The standard of care for ISS or pediatric growth hormone deficiency (GHD) is to continue daily somatotropin therapy until the conclusion of puberty, verified when all physes have completely fused by plain radiography or when annualized growth velocity falls below 0.5 cm/year, whichever occurs first. This patient’s annualized growth velocity of 2.6 cm/year between 12/13/23 and 5/17/24 was abnormally low with a Z-score below –2 SDs below the mean.

The patient is a 15-year-old male who has been diagnosed with septo-optic dysplasia resulting in pituitary growth hormone deficiency. He has been receiving growth hormone for more than 12 years. The patient has responded well to treatment. In September 2004, it was noted the patient was receiving Nutropin at 2.2 mg once a day and had a height of 177.2 cm. On 5/17/04, the patient’s IGF-1 level was 571 and IGFBP-3 was 4.4 (both high normal values). The patient’s parents indicate the patient’s mid-parental height was 69.5 inches, though there is some indication in the submitted documentation the mid-parental height may be 72 inches. At this time, the patient, by whatever criteria is used for attainment of mid-parental height, should have achieved this mark, albeit his epiphysis may not have completely closed as yet. Therefore, continued therapy for his growth is not necessary or indicated.

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