relugolix — Blue Cross Blue Shield of Illinois

Initial criteria

• The patient is premenopausal (e.g., less than 12 months since last menstrual period)
• ONE of the following: (A) 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 (B) The patient has an intolerance or hypersensitivity to ONE prerequisite agent (hormonal contraceptive, NSAID [including COX-II inhibitors]) OR (C) The patient has an FDA labeled contraindication to ALL prerequisite therapies (hormonal contraceptives [oral, topical patches, implants, injections, IUD], NSAIDs [including COX-II inhibitors])
• 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 (e.g., elagolix, relugolix) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent
• ONE of the following hepatic and dosing conditions applies: (A) Without moderate hepatic impairment (Child-Pugh/CTP Class B): If initiating or continuing and total duration with 150 mg strength ≤ 24 months per lifetime or 200 mg strength ≤ 6 months per lifetime; OR (B) With moderate hepatic impairment (Child-Pugh/CTP Class B): If 150 mg strength is used and total duration ≤ 6 months per lifetime

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (requests for 200 mg strength reviewed under initial criteria)
• The patient is premenopausal (e.g., 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
• The patient will NOT use the requested agent in combination with another GnRH antagonist (e.g., elagolix, relugolix)
• The patient does NOT have any FDA labeled contraindications
• There is support confirming the number of months the patient has been on therapy AND total lifetime duration has NOT exceeded: (A) Without moderate hepatic impairment and 150 mg ≤ 24 months per lifetime; OR (B) With moderate hepatic impairment and 150 mg ≤ 6 months per lifetime; OR (C) 200 mg ≤ 6 months per lifetime

Approval duration

12 months (BCBSIL/BCBSTX); up to 6 months (others) with lifetime maximums as noted