Diagnosis: Endocrine/Metabolic/Nutritional/Other/Prader-Willi Syndrome
Treatment: Pharmacy/Prescription Drugs/Norditropin Flexpro 10mg/1.5ml, 0.3 mg subcutaneously injected daily for one year
The health plan denied the requested Norditropin Flexpro 10mg/1.5ml, 0.3 mg subcutaneously injected daily for one year as not medically necessary.
The health plan's determination is upheld.

This is a female diagnosed with Prader-Willi Syndrome (PWS). This request is for Norditropin. As reported; she was diagnosed with PWS since being an infant. She was started on growth hormone (GH) therapy and she was maintained on GH therapy. As per visit note , she has hypogonadism, and she is on GH therapy and estrogen therapy. She is on Nutropin 0.4 mg (0.18 milligrams/kilograms/week (mgxkgxwk).
Her Insulin-like Growth Factor 1 (IGF1) IGF1 was 109.
At a later date her IGF1 was 103.
At a later date her IGF1 was 103 (107-367).
At issue is the medical necessity for Norditropin Flexpro 10 milligrams (mg)/1.5 milliliters (ml), 0.3 mg.

The health plan's determination of medical necessity is upheld, in whole.

No. The request is not medically necessary.
GH for adults with PWS is not Food and Drug Administration (FDA) approved. [1,-2] There are a few small studies that show a small beneficial effect on fat mass and lean body mass. [5-11]
The consensus statement recognizes that patients with Prader-Willi syndrome may be growth hormone deficient. [3,4] The recommendations of the consensus statement are to test all adult patients with Prader-Willi syndrome for growth hormone deficiency.
The patient has Prader-Willi syndrome and a low IGF-I but does not have documentation of growth hormone stimulation testing. Although it is likely that the patient has growth hormone deficiency, testing of the growth hormone axis will be necessary to confirm that.