Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Endometriosis
Treatment: Lupron Depot-3 Month 11.25mg
The insurer denied: Lupron Depot-3 Month 11.25mg
The denial is overturned

The patient is a young adult female with stage 1 endometriosis determined by laparoscopy, chronic pelvic pain, ocular migraines, anxiety/depression, central sensitization, and myofascial pain. She has been on Lupron depot, levonorgestrel-containing IUD (intrauterine device), and Aygestin, with improvement in her pain. She has received 4 doses approximately 3 months apart. The plan is for another dose.
The request has been denied coverage by the health plan as not medically necessary. This denial is being appealed.

The requested Lupron Depot is medically necessary.

Endometriosis is a gynecologic condition that occurs in 6-10% of women of reproductive age, with a prevalence of 38% (range, 20-50%) in infertile women, and in 71-87% of women with chronic pelvic pain. 
Gonadotropin-releasing hormone agonists are highly effective in reducing the pain syndromes associated with endometriosis. However, they are not superior to other methods such as combined OCs (oral contraceptives) as first-line therapy. Gonadotropin-releasing hormone agonists may have significant side effects, including hot flushes, vaginal dryness, and osteopenia. Osteopenia has been shown to be reversible with short-term use but may not be with long-term use or use of multiple cycles. As with other suppressive therapy, recurrence of symptoms is common after the medication is discontinued. The recurrence rate at 5-year follow-up, after discontinuing GnRH (gonadotropin-releasing hormone) agonist treatment, ranges from 53% to as high as 73% in women with advanced disease. There may be an option for prolonged use of the GnRH (gonadotropin-releasing hormone) agonist for up to 1 year if add-back therapy is used. When relief of pain from treatment with a GnRH (gonadotropin-releasing hormone) agonist supports continued therapy, the addition of add-back therapy reduces or eliminates GnRH (gonadotropin-releasing hormone) agonist-induced bone mineral loss and provides symptomatic relief without reducing the efficacy of pain relief. Add-back regimens (using either sex-steroid hormones or other specific bone-sparing agents) have been advocated for use in women undergoing long-term therapy (more than 6 months). Such treatment strategies have included progestins alone, progestins and bisphosphonates, low dose progestins, and estrogens.
The FDA (United States Food and Drug Administration) has approved the daily use of norethindrone, 5 mg (milligrams), as add-back therapy with a GnRH (gonadotropin-releasing 
hormone) agonist. In a comparison of different add-back regimens, GnRH (gonadotropin-releasing hormone) and norethindrone, with or without a low-dose estrogen (conjugated estrogens 0.625 milligrams daily), were found to decrease the side effect profile and maintain efficacy. If women do 
not tolerate the high dose norethindrone, transdermal estradiol with medroxyprogesterone acetate can be used (transdermal estradiol, 25 micrograms per day plus medroxyprogesterone acetate 2.5 milligrams orally daily). 
Add-back treatment does not diminish the efficacy of pain relief observed during 3 months or 6 months of GnRH (gonadotropin-releasing hormone) agonist therapy. Therefore, the add-back 
regimen can be started immediately with the GnRH gonadotropin-releasing hormone) agonist. 

In review of the medical record provided, the patient has chronic pelvic pain secondary to endometriosis. She has been on depot Lupron for 9 months with add back of norethindrone. This has helped manage her pain. The FDA (United States Food and Drug Administration) has approved this for 12 months, so the next injection does meet the standard of medical care and is appropriate and necessary for the management of this patient's pain. It meets the definition of medical necessity.