Diagnosis: Subserosal Leiomyoma of Uterus
Treatment: Lupron Depot-3 month 11.25 mg (milligrams)
The insurer denied the request for Lupron Depot-3 month 11.25 mg.
The health plan's determination is upheld.

This patient is a female under consideration of Lupron Depot-3 month 11.25 milligram (mg) injection for treatment of a subserosal leiomyoma of the uterus. In this case, the medication under consideration is a non-formulary drug under the health plan. The patient is noted to have symptomatic fibroids and is not a surgical candidate as she will be needing a heart transplant. The health plan does not cover Lupron Depot 11.25 mg except for uterine leiomyomata that have resulted in bleeding to anemia. In this case, the patient is reported to have normal menses that are regular. She has a prior history of ovarian cystectomy.

The review of systems noted normal periods, absent abdominal pain, absent pelvic pain during periods, and absent abnormal bleeding. The patient is noted to be 221 pounds. Her body mass index (BMI) is 36 kilograms per meters squared (kg/m2). The diagnosis of excessive menstruation with a regular cycle is assigned. Lupron Depot was prescribed. The magnetic resonance imaging (MRI) of the pelvis noted several fibroids with a uterus of 9 by 7 by 11 centimeters (cm). The endometrial stripe is 2 millimeters (mm). The largest myoma is a posterior intramural myoma of 3.2 by 4.6 by 4.4 cm. There is a small intracavity fibroid of 0.9 by1.0 by 0.8 cm. The historical records from an appointment were reviewed.

In this case, the patient would not be indicated for Lupron Depot 11.25 mg injection for leiomyomas without anemia also being present. A review of the medical records in this case noted that the patient has regular and normal periods with a negative review of systems for abnormal bleeding, pain or anemia. The patient is noted to have leiomyomas by MRI of the pelvis. In this case, the endometrial stripe is actually very thin. There has been no evaluation for anemia present and there is no positive review of symptoms to support anemia. In this case, a complete blood count with mean corpuscular volume (MCV) should be performed and if there is microcytosis, formal iron studies should also be completed. In this case, under the formulary, this drug is approvable for treatment of anemia due to fibroids. If absent, there would be no indication for this medication for therapy and it also carries risk for reduced bone mineral density over time.

In this case, the patient would be treated with nonsteroidal anti-inflammatory drugs (NSAIDs), oral Progesterone, or oral contraceptive pills for abnormal bleeding if present. This would be considered the mainstay of care for leiomyomas if heavy bleeding or abnormal bleeding are present. However, in this case, the review of systems was normal without any complaints and thus, there may not need to be any interventions. At this time and based upon the medical records, the non-formulary use of Lupron Depot 11.25 injection is not clinically appropriate for this presentation at this time.

The health plan's determination is upheld in whole.