Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Small for Gestational Age.

Treatment: Norditropin FlexPro, 10 milligrams per 1.5 milliliter subcutaneous solution pen injector 4.5/30 days.

The insurer denied coverage for Norditropin FlexPro, 10 milligrams per 1.5 milliliter subcutaneous solution pen injector 4.5/30 days.

The denial is upheld. 

According to the documentation submitted, this is a child with a history of intrauterine growth restriction and triplet birth born less than 5 pounds. He presented to the Pediatric Endocrinologist's office for growth monitoring. He grows along the third percentile. His predicted height is less than the mid-parental adjusted height. The patient was diagnosed small for gestational age (SGA). The physician recommended starting growth hormone (GH) therapy.  

The health plan acted reasonably, with sound medical judgment and in the best interest of the patient as the request is not medically necessary as described below. 

Growth hormone for the treatment of children who are small for gestational age (SGA) and who fail to exhibit catch-up growth is standard of care. This indication has approval from the FDA[Food and Drug Administration][1] support from consensus guidelines[2-4] and randomized controlled trial evidence to support its use[5-9]. The most recent and most relevant consensus guidelines are those of the combined meeting of the International Societies of Pediatric Endocrinology and the Growth Hormone Research Society[2]. Here it is recommended that if a patient fails to exhibit catch-up growth by either two or four years, that GH [growth hormone] therapy be initiated. At a given age, this is defined as <2SD (standard deviation). The diagnosis of SGA is made at birth. The diagnosis of SGA with failure to catch up is made after a growth point at age 2. This diagnosis can be made at any time after age 2 assuming the patient has not had catch up growth to above -2SD. 

The patient's birth weight and birth length and gestational age are not provided. There is no documentation of being small for gestational age.

The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:

Classic Growth Hormone (GH) deficiency
Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH deficiency published by the GH research society[10], the Lawson Wilkins Pediatric Endocrinology Society[3, 11], and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists[4]. The diagnosis is based on auxological, biochemical and sometimes radiological findings. 

The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported.

The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet idiopathic short stature criteria. 

The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.

Based on the above, the medical necessity for the Norditropin FlexPro 10 milligrams per 1.5 milliliter subcutaneous solution pen injector 4.5/30 days is not substantiated. The insurer's denial is upheld.