Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth Hormone Deficiency
Treatment: Norditropin Flexpro
The health plan denied the Norditropin Flexpro.
The determination is overturned.

The patient was diagnosed with growth hormone deficiency (GHD). As reported; she is on growth hormone (GH) therapy (she had burning with Nutropin and is now on Norditropin). She had experienced menarche. Her GH stimulation test with arginine and clonidine peaked at 9.88 and 7.6 respectively. Her height velocity on therapy is reported to be 5.91 centimeters per year (cm/yr). The growth chart reveals that she is continuing to grow at an excellent height velocity. Her breasts were at Tanner 3. Her pretreatment Insulin-like Growth Factor 1 (IGF1) was 246 (range 90-581).
Her pretreatment height 119 centimeters (cm) (-3.01 standard deviation score (SDS)). Her height on therapy was 146.9 cm (-2.10 SDS).
Her mid parental height is 171.45 cm (plus [+] 1.26 SDS).
This request is for Norditropin and at issue is whether the Norditropin Flexpro is medically necessary.
This is medically necessary. The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:
Classic 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 [1], the Lawson Wilkins Pediatric Endocrinology Society [2, [3], and the medical guidelines for 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 standard deviations (SD) below the mean; 2) height more than 1.5 SD below the mid parental height SD; 3) height more than 2 SD below the mean and a height velocity over 1 year more than 1 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 (yr)  of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 yr or more than 1.5 SD sustained over 2 yr. The biochemical criteria include low IGF1 or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10ng/ml.
This patient met biochemical criteria. GH stimulation testing peaked at less than 10ng/ml. the patient met height criterion 1 as height is more than 3 SD below. The patient met height and biochemical criteria for the diagnosis of GH deficiency. GH in the treatment of GH deficiency is medically necessary.
The patient is on continuing therapy. Continuation of growth hormone is indicated until the height velocity drops below 2 cm reported. The patient's height velocity is far more than 2 cm per year.
Continuation of growth hormone is consistent with generally accepted standards of medical practice and is therefore medically necessary.