Orilissa — Blue Cross Blue Shield of Texas

Initial criteria

• The patient is premenopausal (less than 12 months since last menstrual period)
• ONE of the following:
• The patient has tried and had an inadequate response to ONE prerequisite agent (hormonal contraceptive, NSAID including COX-II inhibitors) used in the treatment of the requested indication OR
• The patient has an intolerance or hypersensitivity to ONE prerequisite agent (hormonal contraceptive, NSAID including COX-II inhibitors) used in the treatment of the requested indication OR
• The patient has an FDA labeled contraindication to ALL prerequisite therapies (hormonal contraceptives—oral, topical patches, implants, injections, IUD, NSAIDs including COX-II inhibitors) used in the treatment of the requested indication
• The patient’s bone health has been assessed and allows for initiating therapy with the requested agent
• The patient will NOT be using the requested agent in combination with another GnRH antagonist agent targeted in this program (elagolix, relugolix)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• ONE of the following hepatic/strength conditions applies:
• The patient does NOT have coexisting moderate hepatic impairment (Child-Pugh Class B) AND either initiating therapy or (if continuing) documented months on therapy with total duration limits: 150 mg ≤ 24 months lifetime OR 200 mg ≤ 6 months lifetime OR
• The patient HAS coexisting moderate hepatic impairment (Child-Pugh Class B) AND the requested strength is 150 mg AND either initiating therapy or documented months on therapy ≤ 6 months lifetime

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (requests for 200 mg always reviewed under initial criteria)
• The patient is premenopausal (less than 12 months since last menstrual period)
• The patient has had clinical benefit with the requested agent
• The patient’s bone health has been assessed and allows for continued therapy with the requested agent
• The patient has NOT had a fragility fracture since starting therapy with the requested agent
• The patient will NOT be using the requested agent in combination with another GnRH antagonist agent targeted in this program (elagolix, relugolix)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• There is support confirming the number of months the patient has been on therapy with the requested agent and strength
• The total duration of treatment complies with hepatic/strength max: 150 mg without hepatic impairment ≤ 24 months lifetime; 150 mg with moderate hepatic impairment ≤ 6 months lifetime; 200 mg ≤ 6 months lifetime

Approval duration

12 months (BCBSIL/BCBSTX); up to 6 months all other plans with lifetime limits by strength/impairment