relugolix — Blue Cross Blue Shield of Montana

Initial criteria

• The patient has a diagnosis of moderate to severe pain associated with endometriosis
• 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 (i.e., 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 (i.e., hormonal contraceptive, NSAID [including COX-II inhibitors]) OR C. The patient has an FDA labeled contraindication to ALL prerequisite therapies (i.e., hormonal contraceptives [i.e., 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 impairment criteria: A. The patient does NOT have coexisting moderate hepatic impairment (Child-Pugh/CTP Class B) AND either initiating therapy or, if not initiating, documentation of months on therapy and total duration has not exceeded 24 months (150 mg) or 6 months (200 mg) per lifetime OR B. The patient does have coexisting moderate hepatic impairment (Child-Pugh/CTP Class B) AND requested strength is 150 mg AND total duration has not exceeded 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 should always be 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 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)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• BOTH of the following: A. There is support confirming the number of months the patient has been on therapy AND B. ONE of the following: 1. The patient does NOT have coexisting moderate hepatic impairment AND total duration with requested strength has NOT exceeded 24 months per lifetime OR 2. The patient does have coexisting moderate hepatic impairment AND total duration with requested strength has NOT exceeded 6 months per lifetime

Approval duration

BCBSIL and BCBSTX: 12 months; all other plans: up to 6 months (≥3 months for MT/NM) with lifetime maximum per hepatic status and strength per criteria