Diagnosis: Fibroid Uterus
Treatment: Orilissa (Elagolix)
The insurer is denied coverage for Orilissa (Elagolix).
The denial is upheld.

This is a female patient with a diagnosis of fibroid uterus complaining of pelvic pain. Ultrasound showed a fibroid uterus and a hemorrhagic cyst. The patient was offered the combination of Orilissa and Voltaren for pain control.

Based on the review of the medical record, the etiology of this patient's pain is not clear. The information suggests that the pain was due to the patient's uterine fibroids. The patient also had a hemorrhagic cyst. The patient was never diagnosed with endometriosis (laparoscopically) or was treated for endometriosis. The diagnosis was based on a one time finding of a hemorrhagic cyst. Ideally, the patient's ultrasound needs to be repeated to see whether or not the cyst has resolved.

If the patient's pain is caused by endometriosis then the following applies: the treatment of endometriosis-related pain is based on the severity of symptoms, and other causes of pelvic pain should be excluded prior to treatment. For women with mild to moderate pain, nonsteroidal anti-inflammatory drugs (NSAIDs) and continuous hormonal contraceptives are recommended rather than either agent alone (Grade 2C). These therapies are low-risk, have few side effects, are low-cost, and are generally well-tolerated compared with other medical therapies. For women with adequate symptom improvement, continuation of the hormonal therapy/NSAID regimen until pregnancy is desired or until the average age of menopause is reached. For women whose symptoms do not improve, continuation of NSAID treatment and an alternate hormonal combination (e.g., change to a different estrogen-progestin contraceptive or norethindrone acetate) are suggested. For women with severe symptoms, symptoms that do not respond to the above therapies, or recurrent symptoms, a trial of gonadotropin-releasing hormone (GnRH) agonist with add-back hormonal therapy is recommended (Grade 2C). GnRH agonist treatment has demonstrated efficacy without the risks or negative impact on ovarian reserve of surgery.

A new drug Orilissa just approved by the FDA is a Gonadotropin-hormone releasing (GnRH) antagonist which also suppresses the pituitary gonadotropin hormone production and creates a hypoestrogenic state.

This patient does not have a definitive diagnosis of endometriosis. This patient did not fail treatment with oral contraceptives, progestins or Lupron, nor does she have a contraindication to trial these products. Thus, as of now, Orilissa is not considered medically necessary for this patient.

The health care plan acted reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Orilissa (Elagolix) should be upheld. The medical necessity is not substantiated.