ORILISSA (elagolix)

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)