Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Uterine fibroids 
Treatment: Lupron Depot
The insurer denied the Lupron Depot. 
The denial is upheld. 

The patient is a woman with a history of uterine fibroids and pelvic pain. According to the physician appeal letter, she has undergone three laparotomies for the condition including a myomectomy. She consulted her gynecologist who has prescribed continuous depot leuprolide and norethindrone. Continued depot leuprolide and norethindrone treatment has been recommended by the gynecologist.

No, the proposed Lupron Depot is not medically necessary.

The proposed Lupron Depot is not medically necessary. 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: "Gonadotropin-releasing hormone agonists lead to amenorrhea in most women and provide a 35-65% reduction in leiomyoma volume within 3 months of treatment. 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. The effects of GnRH agonists are temporary, with gradual recurrent growth of leiomyomas to previous size within several months after cessation of treatment. In addition, the significant symptoms of pseudomenopause and adverse impact of the induced hypoestrogenism on bone density limit their suggested use to no more than 6 months without hormonal add-back therapy. If treatment is continued for more than 6 months, low-dose steroidal add-back therapy should be considered to minimize continued bone loss and vasomotor symptoms. Whereas contraceptive steroid add-back therapy can be used for some diseases, for leiomyomas only low-dose preparations, equivalent to menopausal hormonal therapy, have been studied. It also appears that using a sequential regimen, in which a GnRH agonist is first used to achieve down regulation to which steroids are added after 1-3 months of therapy, gives maximal results. However, the addition of progestin add-back therapy results in an increase in mean uterine volume to 95% of baseline within 24 months." 

The patient is status post abdominal myomectomy. There is no evidence in the medical records to confirm the presence of postoperative fibroid recurrence. There is no evidence in the medical records indicating the length of postoperative GnRH agonist treatment, or the treatment plan for this patient. A pelvic ultrasound done does not report uterine findings. The condition of uterine fibroids and the medical indication for GnRH agonist treatment is not confirmed. Therefore, according to the standard of care, the medication is not medically necessary.