Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Leiomyoma of uterus, unspecified
Treatment: Lupron Depot 3.75MG (milligrams)
The insurer denied: Lupron Depot 3.75MG (milligrams)
The denial is overturned.

The patient is an adult female with abnormal uterine bleeding secondary to a fibroid uterus. She underwent surgical intervention with a hysteroscopic myomectomy dilatation and curettage. This revealed normal pathology. The fibroid however was large and was unable to be completely resected. The plan is for suppression of menses with a GnRH (gonadotropin-releasing hormone) agonist lupron depot. This has been denied coverage by the health plan as not medically necessary. This is being appealed.

The requested Lupron Depot is medically necessary.

According to Stewart, gonadotropin-releasing hormone (GnRH) agonists are the most effective medical therapy for uterine myomas. These drugs work by initially increasing the release of gonadotropins, followed by desensitization and downregulation to a hypogonadotropic, hypogonadal state that clinically resembles menopause. 

The side effects of long-term GnRH (gonadotropin-releasing hormone) agonist administration can be minimized during therapy by giving add-back therapy with low dose estrogen-progestin after the initial phase of downregulation. Using OC (oral contraceptive) add-back for leiomyomas is not indicated.

According to the American College of Obstetrics and Gynecology, Gonadotropin-releasing hormone (GnRH) agonists, either with or without add-back hormonal therapy, are recommended for the short-term treatment of abnormal uterine bleeding and uterine enlargement associated with uterine leiomyomas and as a bridge to other treatment strategies. Use of a GnRH (gonadotropin-releasing hormone) agonist is a short-term management strategy that is meant to bridge treatment to interventional procedures, surgical management, menopause, or other medical therapies. Treatment with GnRH (gonadotropin-releasing hormone) agonists is associated with reduction in leiomyoma size and overall size of the uterus, decreased AUB-L (abnormal uterine bleeding leiomyoma) and dysmenorrhea, and improvement in quality-of-life measures (i.e., days of bleeding, pelvic pressure, pelvic pain, urinary frequency, and constipation). Leiomyoma regrowth, often back to pretreatment levels, is observed between 3 and 9 months after cessation of treatment, which explains why it is primarily used as a bridge therapy.

GnRH (gonadotropin-releasing hormone) agonists often are used to reduce uterine volume before surgical therapy, which may facilitate the use of a minimally invasive surgical route, allow for a smaller incision, or enable the use of an incision type associated with decreased morbidity. The use of a GnRH (gonadotropin-releasing hormone) agonist before surgical management also is associated with an increase in preoperative hemoglobin levels by an average of 0.88 g/dL (grams per deciliter). 

In review of the medical record and current literature there is evidence to support the use of GnRH (gonadotropin-releasing hormone) agonists for volume reduction of myomas, which is the clinical indication in this scenario. The goal according to the information provided is to reduce the size of the fibroid using depo lupron to avoid major surgery with a hysterectomy. After the fibroid has shrunk the plan is to then change to oral medications for long term maintenance of the abnormal bleeding. The literature does support the use of GnRH (gonadotropin-releasing hormone) agonists for this clinical circumstance. They can be used to bridge treatment or in the situation where surgical intervention is not warranted, desired, or safe. Therefore, this is a standard of medical practice, appropriate for the treatment of uterine fibroids, not for convenience, and not more intensive than alternatives (surgical intervention with a hysterectomy). Medical necessity is met.