Orilissa — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Patient has a diagnosis of moderate to severe pain associated with endometriosis
• Patient is premenopausal (e.g., less than 12 months since last menstrual period)
• ONE of the following: A. Patient has tried and had an inadequate response to ONE prerequisite agent (i.e., hormonal contraceptive, NSAID [including COX-II inhibitors]) used in treatment of requested indication OR B. Patient has an intolerance or hypersensitivity to ONE prerequisite agent (i.e., hormonal contraceptive, NSAID [including COX-II inhibitors]) used in treatment of requested indication OR C. Patient has an FDA labeled contraindication to ALL prerequisite therapies (i.e., hormonal contraceptives, NSAIDs [including COX-II inhibitors]) used in treatment of the requested indication
• Patient’s bone health has been assessed AND allows for initiating therapy with the requested agent
• Patient will NOT be using the requested agent in combination with another GnRH antagonist agent targeted in this program (e.g., elagolix, relugolix) for the requested indication
• Patient does NOT have any FDA labeled contraindications to the requested agent
• ONE of the following hepatic and dose conditions: A. Patient does NOT have coexisting moderate hepatic impairment (Child-Pugh/CTP Class B) AND ONE of the following: 1. Patient is initiating therapy with the requested agent and strength OR 2. Patient is not initiating therapy and BOTH: A. There is support confirming number of months on therapy AND B. ONE of: 1. Requested strength is 150 mg AND total duration has NOT exceeded 24 months per lifetime OR 2. Requested strength is 200 mg AND total duration has NOT exceeded 6 months per lifetime OR B. Patient DOES have coexisting moderate hepatic impairment (Child-Pugh/CTP Class B) AND BOTH: 1. Requested strength is 150 mg AND 2. ONE of: A. Patient is initiating therapy OR B. Patient is not initiating therapy AND BOTH: 1. Support confirming number of months on therapy AND 2. Total duration with requested strength has NOT exceeded 6 months per lifetime

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process (requests for 200 mg strength should always be reviewed under initial criteria)
• Patient is premenopausal (e.g., less than 12 months since last menstrual period)
• Patient has had clinical benefit with the requested agent
• Patient’s bone health has been assessed AND allows for continued therapy with the requested agent
• Patient has NOT had a fragility fracture since starting therapy with the requested agent
• Patient will NOT be using the requested agent in combination with another GnRH antagonist agent targeted in this program (e.g., elagolix, relugolix) for the requested indication
• Patient does NOT have any FDA labeled contraindications to the requested agent
• BOTH of the following: A. There is support confirming number of months on therapy with requested agent and strength AND B. ONE of the following: 1. Patient does NOT have coexisting moderate hepatic impairment (Child-Pugh/CTP Class B) AND total duration with requested strength has NOT exceeded 24 months per lifetime OR 2. Patient DOES have coexisting moderate hepatic impairment (Child-Pugh/CTP Class B) AND total duration with requested strength has NOT exceeded 6 months per lifetime

Approval duration

BCBSIL and BCBSTX: 12 months; others: up to 6 months (min 3 months for MT/NM) with lifetime max per strength (24 months if 150 mg without hepatic impairment; 6 months if 150 mg with hepatic impairment; 6 months if 200 mg)