Appeal type: Medical necessity
Decision: Upheld

Dx: Gynecological
Tx: Pharmacy/Prescription Drugs
Denied: Lupron Depot 
Denial: UPHELD in whole

The patient is a female under consideration for Lupron Depot 3.75 milligrams (mg) for the indication of fibroids and menorrhagia. The patient is noted to have a history of severe anemia and menorrhagia. She has received iron infusions for this in the past and also has large fibroids. She was scheduled for surgery, but this has been placed on hold given the viral pandemic. This therapy is proposed to prevent any ongoing bleeding while surgery is delayed. The patient is noted to have a long standing history of anemia treated with iron, iron infusion and blood transfusion. She is considered for Lupron at this time for control of bleeding given her history. Surgery had been planned but has been delayed given this is elective surgery. In this case, the patient has received 6 doses of Lupron. The patient is noted to have a body mass index (BMI) of 47 kilograms per square meter (kg/m2). The uterus is 14 x 7 x 7 centimeter (cm). The patient is noted to have decreased uterine size as of this evaluation. She also has three prior vaginal deliveries. The subject under review is the medical necessity for the Lupron Depot.

The health plan's determination is upheld in whole.

Based upon a review of the medical records and the clinical information and recommendations of American College of Obstetricians and Gynecologists (ACOG), the use of Lupron Depo 3.75 mg for menorrhagia beyond 6 months would not be medically necessary in this case. Lupron, a gonadotropin-releasing hormone agonist, has 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. By inducing amenorrhea, gonadotropin-releasing hormone (GnRH) agonists have been shown to improve hematologic parameters, shorten hospital stay, and decrease blood loss, operating time, and postoperative pain when given for 2-3 months preoperatively. In this case, the patient has received this for 6 months and has been stable. She is planned for surgery that has to be delayed due to the pandemic. At this time, ongoing Lupron is not indicated and if concerns are present for bleeding in a patient of BMI 47, consideration of progesterone should be given for control of bleeding until surgery as per the standards of care.
According to the literature, hormonal management is considered the first line of medical therapy for patients with acute abnormal uterine bleeding (such as menorrhagia in this case) without known or suspected bleeding disorders. Treatment options include intravenous (IV) conjugated equine estrogen, combined oral contraceptives (OCs), and oral progestins. In this case, where the BMI is 47, consideration of another medication should be given at this time. There would be no further role for Lupron Depo 3.75 as the patient has completed 6 months of this therapy which is the recommended limit for this agent and exposure. Thus, the requested health service/treatment of Lupron Depot 3.75 mg would not be medically necessary at this time.