Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Fibroids
Treatment: Lupron Depot-3 Month 11.25 mg (milligrams)
The insurer denied Lupron Depot-3 Month 11.25 mg.
The denial is overturned.

The patient is an adult female with a fibroid uterus pushing on her left ureter causing hydronephrosis and pain.  She had an ultrasound revealing an enlarged uterus with two distinct large fibroids, largest measuring 7.8 centimeters.  The plan is for a vaginal hysterectomy.  The request is for the use of Lupron Depot prior to surgery to shrink the fibroids to allow for minimally invasive surgery and to stop the pressure of the left ureter.
This request has been denied by the health plan as not necessary.  This is being appealed.

The proposed treatment 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.  Most women will develop amenorrhea, improvement in anemia (if present), and a significant reduction (35 to 60 percent) in uterine size within three months of initiating this therapy, thus achieving improvement in both categories of myoma symptomatology.

Gonadotropin-releasing hormone agonists are primarily used as preoperative therapy.  Gonadotropin-releasing hormone agonists are approved for administration for three to six months prior to leiomyoma-related surgery in conjunction with iron supplementation to facilitate the procedure and enable correction of anemia.  Reduction in uterine size can facilitate subsequent surgery by reducing intraoperative blood loss and by increasing the number of women who are candidates for a vaginal procedure, a transverse (rather than vertical) abdominal incision, or a minimally-invasive procedure. 


The Food and Drug Administration has approved use of leuprolide and iron preoperatively in women with leiomyomas, but not for medical management of these tumors.  Therapeutically equivalent options include leuprolide acetate depot (intramuscularly 3.75 mg [milligrams] per month or 11.25 mg per three months), goserelin acetate (3.6 mg per month subcutaneously or 10.6 mg subcutaneous implant every three months) or nafarelin acetate (administered as a twice daily intranasal spray).  However, the fact that these agents are best administered at specific times in the menstrual cycle (late luteal if no chance of pregnancy or with onset of menses), cause an increase in estrogen prior to downregulation and take a minimum of three weeks to reach this down-regulated state means that some women who might benefit are not candidates for therapy.

In review of the medical record and current literature, there is evidence to support the use of gonadotropin-releasing hormone agonists for the preoperative period to help volume reduction of the myomas.  Therefore, there is evidence in the literature to support the use of gonadotropin-releasing hormone agonists in the preoperative period and this clinical scenario.  Therefore, the request is medically necessary.