ORILISSA (elagolix)
SELF ADMINISTRATION
Indications for Prior Authorization:
- Indicated for the management of moderate to severe pain associated with endometriosis.
Prior Authorization Criteria:
- Patient is 18 years of age or older, AND
- Diagnosis of moderate to severe pain associated with endometriosis, AND
- Patient has tried and failed NSAIDs and continuous hormonal contraceptives for the treatment of mild to moderate endometrial pain, AND
- Patient has tried and failed a complete trial of gonadotropin-releasing hormone (GnRH) agonist therapy (e.g. leuprolide) for more severe pain, AND
- Patient does not have a contraindication to therapy (e.g. pregnancy, osteoporosis, severe hepatic impairment, concomitant use of strong OATP 1B1 inhibitors [e.g. cyclosporine, gemfibrozil])
Renewal Criteria:
- Medical record documentation of symptom improvement, AND
- Current therapy on 150 mg daily dose, AND
- The patient does not have a coexisting condition (e.g. dyspareunia or hepatic impairment)
Dosing:
- Patients without a coexisting condition: 150 mg daily
- Max treatment duration: 24 months
- Patients with Dyspareunia: 200 mg twice daily
- Max treatment duration: 6 months
- Moderate Hepatic Impairment (Child-Pugh Class B): 150 mg daily
- Max treatment duration: 6 months
Approval:
- Initial: 6 months
- Renewal: 6 months (for a total treatment duration of up to 24 months)
Last review date: May 30, 2019