Diagnosis: Growth hormone deficiency

Treatment: Omnitrope Solution Cartridge (SOCT) 10 milligrams (MG)/ 1.5 milliliters (ML)

The insurer denied coverage for Omnitrope SOCT 10MG/1.5ML

The denial is overturned

This is a young male diagnosed with short stature. As reported, he is taking Omnitrope 1 mg daily. His mother states he did not miss any doses of medication. He has been taking Omnitrope for over 3 years. His Growth Hormone (GH) stimulation test pre-treatment with clonidine and arginine peaked at 9.9. His magnetic resonance imaging (MRI) was normal. His recent bone age revealed a difference of a few months less than chronological age (CA). His height velocity on therapy is reported to be 7.1 centimeters/years (cm/yr). Recent notes show he is at tanner 1. Previous insulin-like growth factor 1 (IGF1) was 65 and insulin-like growth factor-binding protein 3 (IGFBP3) was 1793. His recent weight was 30.6 kilograms (kg). His recent height was 137.3 cm [-1.46 standard deviation score (SDS)].

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 yr more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 yr in children over 2 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 IGFBP3 or GH stimulation testing with a peak GH less than 10 nanograms (ng)/ ml.

The patient has growth hormone deficiency based on prior approvals. The patient is continuing therapy. The documentation provided reports that the patient did not miss any doses of the medication. The patient's height velocity on treatment is excellent. The patient has open growth plates. Continuation of growth hormone is consistent with generally accepted standards of medical practice and is therefore medically necessary.

The references provided are the most current/relevant to the case.

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 Omnitrope SOCT 10MG/1.5ML services is substantiated.