Saizen denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested Saizen growth hormone for treatment of the enrollee’s short stature. Findings: The physician reviewer found that the records document that this patient’s height is more than two standard deviations below the mean for age and gender. In addition, his height velocity off growth hormone therapy is poor and his bone age is delayed. 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: (1) height more than 2.25 standard deviations below the mean for age or more than two standard deviations below the mid-parental height percentile; (2) growth velocity less than the 25th percentile for bone age; (3) bone age more th…

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for Saizen 8.8 mg vial for treatment of the enrollee’s growth hormone deficiency. Findings: The physician reviewer found that the request for Saizen 8.8 mg vial is medically necessary for treatment of the patient’s medical condition. According to the documentation submitted for review, the patient has had a good response to GH therapy and has had no adverse reactions to Saizen. The patient experienced an allergic reaction to Nutropin, so brand name Saizen is medically necessary for treatment of the patient’s GH deficiency. The patient’s epiphyses remain open so continued treatment until epiphyseal fusion is clinically indicated. As such, the request for Saizen 8.8 mg vial has been established as medically necessary for treatment of the patient’s medical condition.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested growth hormone (GH) Saizen for treatment of the enrollee’s idiopathic short stature. The physician reviewer found that this patient has short stature but normal growth velocity given the presence of very early puberty, normal growth factors, a normal GH response on provocative GH testing, and no morphological abnormalities of the pituitary gland or midline brain structures. Thus, he does not have classic GH deficiency. Based on the bone age and height, the estimated final adult height is shorter than expected based on the genetic potential, but not short enough to meet the U.S. Food and Drug Administration (FDA) criteria for a trial of GH therapy for idiopathic short stature.

The parent of a 13-year-old male enrollee has requested growth hormone therapy (Saizen, 8.8mg, 1.5 cartridge) for treatment of the enrollee’s growth failure in the setting of an abnormal pituitary MRI. Findings: The physician reviewer found that although this patient’s height is more than two standard deviations below normal for age and sex, his adult predicted height based on one bone age assessment and height measurement falls within normal range for an adult male. Although the provider argues that this patient’s growth velocity is abnormally low, the low growth velocity of 3.2 cm per year is based only on two measurements that are 3 ½ months apart, and the duration of time between these two measurements is not long enough to declare the growth velocity to be abnormally low.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Saizenwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.