Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth Hormone Deficiency.
Treatment: Norditropin Flex Pro 5mg/1.5ml SC SOPN.
The insurer denied the Norditropin Flex Pro 5mg/1.5ml SC SOPN.
The denial is upheld.

This is a male diagnosed with Growth Hormone Deficiency (GHD). This request is for Norditropin Flex Pro 5mg/1.5ml subcutaneous (SC) solution pen injector (SOPN.)  As reported, the patient was diagnosed with hypothyroidism; pseudo-hypoparathyroidism 1a. His baseline height was 151 centimeters (cm) with projected height of 165 centimeters (cm) and noting currently at 10% for height. His epiphysis are open. He could not tolerate the growth hormone (GH) stimulation test. Insulin-like growth factor 1 (IGF1) was 116 (101-620); Z-score was - [minus] 1.3 standard deviation (SD).Approximately three months later the insulin-like growth factor 1 (IGF1) was 122 (101-620); Z-score was - [minus] 1.2 standard deviation (SD). His weight was 85.7 kilograms (kg). No height recorded; no chart height.

No. The proposed treatment is not medically necessary.
Classic growth hormone (GH) deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency published by the growth hormone (GH) research society [1], the Lawson Wilkins Pediatric Endocrinology Society [2, [3], and the medical guidelines for growth hormone (GH) use provided by the American Association of Clinical Endocrinologists [4]. The above referenced guidelines are the latest available guidelines from these respective societies. 

The diagnosis is based on height, height velocity, biochemical and sometimes radiological findings. The height and height velocity criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are 1) severe short stature, defined as a height more than 3 SD below the mean; 2) height more than 1.5 standard deviation (SD) below the mid parental height standard deviation (SD); 3) height more than 2 standard deviation (SD) below the mean and a height velocity over 1 year more than 1 standard deviation (SD) below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year in children over 2 years of age; 4) In the absence of short stature, a height velocity more than 2 standard deviation (SD) below the mean over 1 year or more than 1.5 standard deviation (SD) sustained over 2 years. The biochemical criteria include low Insulin-like growth factor 1 (IGF1) or Insulin Like Growth Factor Binding Protein 3 (IGFBP3) or growth hormone (GH) stimulation testing with a peak growth hormone (GH) less than 10ng/ml.

The patient did not meet biochemical criteria. Growth hormone stimulation testing is not reported and insulin like growth factor 1 (IGF-1) was normal.

The patient did not meet height and height velocity criteria as pretreatment height is normal and height velocity is not reported. 

The patient has a genetic condition associated with Growth hormone releasing hormone (GHRH) resistance which can cause growth hormone deficiency. Growth hormone deficiency in these patients is diagnosed in the usual way requiring low Insulin-like growth factor 1  (IGF-I) levels and failed growth hormone stimulation testing. The request is not consistent with generally accepted standards of medical practice and is therefore not medically necessary.

Yes. The health plan did act reasonably, with sound medical judgement and in the best interest of the patient.
The health plan acted reasonably with sound medical judgment, and in the best interest of the patient as the patient does not have documentation of growth hormone deficiency related to Growth hormone releasing hormone (GHRH) resistance from pseudohypoparathyroidism.