Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Short Stature
Treatment: Norditropin Inj [injection] (Norditropin Flexpro) 10/1.5 ml (milliliter)
The insurer denied coverage for Norditropin Inj (Norditropin Flexpro) 10/1.5 ml
The denial is overturned

The patient is a child with the medical diagnosis of idiopathic short stature (ISS). The treating provider ordered Norditropin injection(s) (Norditropin Flexpro) growth hormone (GH), 10/1.5 ml use as directed, eight per month for treatment of ISS.  It is noted, the patient is not growth hormone deficient (GHD). The patient is -2.22 standard deviation(s) (SD) below the mean for age and gender at the most recent measurement. Growth rate documented to be poor with decrement in percentiles for height over time from the 50th to the first percentile at this time. The patient's standard deviation (SD) is -2.22 below the mean for age and gender, and growth velocity is 0.4 centimeters (cm). While the actual height is -2.22 SD, not -2.25 as required by the insurance company, the history of actual growth is very pathological dropping from the 50th percentile to now right, at the first percentile. The patient meets criteria for ISS, as defined by the Food and Drug Administration (FDA) and should be treated. 

The requested therapy is an appropriate next step in therapy for this patient. The treatment is approved for this patient's clinical indication, as per peer reviewed literature. The patient has shown very poor growth and is presently within 0.03 SD for the FDA criteria for ISS, in the context of very poor growth over time. The patient should be treated and Norditropin Flexpro is medically necessary for this patient at this time. 

"Multiple long-acting growth hormone (LAGH) preparations are proceeding through clinical development with some showing promising evidence of short-term clinical efficacy and safety in children and adults with GHD. The relationship of transient elevations of GH and insulin growth-like factor 1 (IGF-I) following administration of LAGH to efficacy and safety remain to be elucidated. For LAGH to replace daily recombinant human growth hormone (rhGH) in the treatment of individuals with GHD, a number of practical questions need to be addressed including methods of dose adjustment, timing of monitoring of IGF-I, safety, efficacy, and cost-effectiveness. Long-term surveillance of efficacy and safety of LAGH preparations will be needed to answer these clinically relevant questions." (Miller, et al., 2020).

"Conclusion: The taskforce suggests that the recommendations be applied in clinical practice with consideration of the evolving literature and the risks and benefits to each individual patient. In many instances, careful review highlights areas that need further research." (Grimberg, et al., 2016).

The Grimberg article is the reference standard of the pediatric endocrine society and would suggest the need to treat.                                

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Norditropin Inj (Norditropin Flexpro) 10/1.5 ml, use as directed (8 per month) services is substantiated.