Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Uterine fibroids.
Treatment: Lupron Depot - three month - 11.25mg.
The insurer denied the Lupron Depot - three month - 11.25mg. 
The denial is upheld. 

No, the proposed treatment is not medically necessary.

The patient is a woman with a history of symptomatic fibroids with menorrhagia. She consulted her gynecologist for fibroid management with uterine preservation. The uterus on pelvic examination was documented as normal size, not enlarged. Uterine artery embolization and myomectomy were discussed and laparoscopic myomectomy was chosen. Preoperative leuprolide 11.25 milligrams (mg) was prescribed. A pelvic ultrasound reported a six centimeter (cm) left uterine fibroid.

The medical records and medical literature were thoroughly reviewed. Lupron is a gonadotropin-releasing hormone (GnRH) agonist. These compounds are synthetic derivatives of the GnRH decapeptide. Amino-acid substitution makes them resistant to degradation, thereby increasing their half-life and prolonging receptor binding. They are inactive if taken orally, but intramuscular, subcutaneous, and intranasal preparations are available. 

Leuprolide acetate (Lupron Depot) is approved by the U.S. Food and Drug Administration (FDA) for leiomyoma treatment. GnRH agonists shrink leiomyomas by targeting the growth effects of estrogen and progesterone. Initially, these agonists stimulate receptors on pituitary gonadotropes to cause a supraphysiological release of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Also called a flare, this phase typically lasts one week. With their long-term action, however, agonists downregulate receptors in gonadotropes, thus creating desensitization to further GnRH stimulation. Correspondingly, decreased gonadotropin secretion leads to suppressed estrogen and progesterone levels one to two weeks after initial GnRH agonist administration. Another possible mechanism is that leiomyomas themselves may contain GnRH receptors, and agonists may directly decrease leiomyoma size. Results with GnRH agonist treatment include dramatic decreases in uterine and leiomyoma volume.

The American College of Obstetrics and Gynecology, in its Practice Bulletin, states: "The GnRH agonist leuprolide acetate is approved by the U.S. Food and Drug Administration (FDA) for preoperative therapy in women with anemia in conjunction with supplemental iron, and it is most useful in women with large leiomyomas...Gonadotropin-releasing hormone agonists have been used widely for preoperative treatment of uterine leiomyomas, both for myomectomy and hysterectomy. They may be beneficial when a significant reduction in uterine volume could change the surgical approach, such as allowing a transverse incision, an endoscopic procedure, or a vaginal hysterectomy...Gonadotropin-releasing hormone agonists have been shown to improve hematologic parameters, shorten hospital stay, and decrease blood loss, operating time, and postoperative pain when given for two to three months preoperatively. Benefits of preoperative use of GnRH agonists should be weighed against their cost and side effects for individual patients." A laparoscopic myomectomy is already planned for a myomectomy of one myoma. Therefore is no evidence presented in the medical record to supports the use of preoperative leuprolide will change the surgical approach with fibroid volume reduction. There is no evidence that the patient is currently anemic. Therefore the medication is not medically necessary. Therefore the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.