
202205-149517
2022
CVS Caremark
Self-Funded
Endocrine/ Metabolic/ Nutritional
Pharmacy/ Prescription Drugs
Medical necessity
Overturned
Case Summary
Diagnosis: Short stature.
Treatment: Genotropin.
The insurer denied coverage for Genotropin. The denial is overturned.
This is a female diagnosed with short stature. This request is for Genotropin. Her GH (growth hormone) stimulation test with arginine and clonidine peaked at 7.9. Her GU (genitourinary) growth was at tanner 1. Her IGF1 (insulin-like growth factor 1) was 128; IGFBP3 (insulin-like growth factor binding protein) was 3127. Her MRI (magnetic resonance imaging) was normal. Her weight was 21.36 kg(kilograms).
Her height was 109 cm (centimeters) (-3.01 SDS (standard deviation score), and she grew to 116.3 cm (-2.50 SDS) with height velocity over 1 year of 7.1 cm/year.
Her mother's height is 162.56 cm, and father's height is not reported. Mid parental height as per chart is 164 cm (+0.10 SDS).
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 SD (standard deviation) 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 (year) 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 10ng (nanograms)/ml (milliliter).
This patient met biochemical criteria. GH stimulation testing peaked at less than 10ng/ml. The patient met height criterion 2 as her height is more than 1.5 SD below target height SD. The patient met both height and height velocity and biochemical criteria for the diagnosis of GH deficiency. GH in the treatment of GH deficiency is medically necessary.
The health plan did not act reasonably with sound medical judgment in the best interest of the patient.
The insurer's denial of coverage for the medication Genotropin is overturned. Medical Necessity is substantiated.