Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Endocrine/Metabolic/Nutritional-other/precocious puberty
Treatment: Pharmacy/Prescription Drugs-Lupron Depot-PED 30milligrams
The health plan denied the prescription drug Lupron Depot-PED 30mg as not medically necessary. The reviewer has upheld in whole the health plan's determination. 

The patient is seeking treatment with gonadotropin releasing hormone analogue (Gorham) for central precocious puberty (CPP). His magnetic resonance imaging (MRI) study of the pituitary gland was normal. He underwent gonadotropin-releasing hormone (GnRH) stimulation testing and his peak luteinizing hormone (LH) response was 23 milli-international units per milliliter (mIU/ml) while follicle-stimulating hormone (FSH) was 11 mIU/ml and testosterone was 478 nanograms per deciliter (ng/dl). At a follow up visit his height was 160.3 centimeter (cm) (72%tile (percentile): plus (+) 0.60 standard deviation (SD)) while his weight was 75.84 kilograms (kg) (99%tile: +2.2 SD). He had grown 2.4 cm in the past 4 month. He was Tanner stage IV for pubertal development. Based on advanced bone age it was assumed that he must have started puberty before the age of 9 years, and treatment with GnRHa was requested to improve height prognosis. At issue is the medical necessity of Lupron Depot-PED 30mg.

No, the requested Lupron Depot-Ped 30mg is not medically necessary for this patient. Precocious puberty is classically defined as the onset of secondary sex characteristics before the age of 8 years in girls and 9 years in boys. These age limits are based on 2.5 standard deviations (SD) below the mean age of pubertal onset normally seen in girls and boys. In boys' pubertal development usually starts with testicular enlargement followed by pubic hair. The diagnosis of (CPP) requires the documentation of the pubertal hypothalamic-pituitary-gonadal axis in a child with progressive pubertal development, pubertal growth rate, and advancement of bone age. A combination of clinical features, bone age, hormonal data are required to diagnose precocious puberty.

This patient was already pubertal when evaluated which is not considered precocious puberty. His GnRH stimulation testing showed pubertal LH and testosterone both of which were not unexpected based on age.
This patient was diagnosed with precocious puberty because of 1.5-year advanced bone age on the assumption that he must have started puberty before the age of 9 years; however, it is not the standard practice. Although his bone age is advanced, he is overweight for his age and height and his body mass index (BMI) is 29.51 kilograms per square meter (kg/m2) (>[greater than] 97%tile) which is consistent with obesity. Obesity can cause advancement in bone age that is not due to precocious puberty. 
GnRH analogs are standard of care for treatment of CPP. Advanced bone age with compromised adult height is the rationale for GnRHa treatment in this case. In boys, when puberty begins before the age of 9 years, the decision to treat is mandatory to preserve height potential. However, based on the guidelines for the treatment of precocious puberty, GnRHa treatment in children with short stature and normally timed puberty is minimally effective in increasing adult height and cannot be suggested for routine use. Besides suppressing puberty, GnRHa treatment also decreases growth velocity which is probably the limiting factor in term of height gain.
This patient is relatively tall for his age and his height was 72%tile. He was Tanner stage IV for pubertal development at the early end of the normal range and cannot be categorized as precocious. He had grown 2.4 cm in the past 4 months and based on his bone age his adult height prediction was about 68.7+/-2 inches which is a reasonable height for male. Suppression of puberty at this point is unlikely to improve his final adult height.