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relugolix — Blue Cross Blue Shield of New Mexico

moderate to severe pain associated with endometriosis

Initial criteria

  • The patient has a diagnosis of moderate to severe pain associated with endometriosis AND
  • The patient is premenopausal (e.g., less than 12 months since last menstrual period) AND
  • 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]) used in the treatment of the requested indication 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]) used in the treatment of the requested indication AND
  • The patient’s bone health has been assessed AND allows for initiating therapy with the requested agent AND
  • 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 AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • ONE of the following: A. The patient does NOT have coexisting moderate hepatic impairment (Child-Pugh [CP]/ Child-Turcotte-Pugh [CTP] Class B) AND ONE of the following: 1. The patient is initiating therapy with the requested agent and strength OR 2. The patient is not initiating therapy with the requested agent and strength and 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 requested strength is 150 mg AND the total duration of treatment with the requested strength has NOT exceeded 24 months per lifetime OR 2. The requested strength is 200 mg AND the total duration of treatment with the requested strength has NOT exceeded 6 months per lifetime OR B. The patient does have coexisting moderate hepatic impairment (Child-Pugh [CP]/ Child-Turcotte-Pugh [CTP] Class B) AND BOTH of the following: 1. The requested strength is 150 mg AND 2. ONE of the following: A. The patient is initiating therapy with the requested agent and strength OR B. The patient is not initiating therapy with the requested agent and strength AND BOTH of the following: 1. There is support confirming the number of months the patient has been on therapy AND 2. The total duration of treatment with the requested strength 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) AND
  • The patient is premenopausal (e.g., less than 12 months since last menstrual period) AND
  • The patient has had clinical benefit with the requested agent AND
  • The patient’s bone health has been assessed AND allows for continued therapy with the requested agent AND
  • The patient has NOT had a fragility fracture since starting therapy with the requested agent AND
  • 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 AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • BOTH of the following: A. There is support confirming the number of months the patient has been on therapy with the requested agent and strength AND B. ONE of the following: 1. The patient does NOT have coexisting moderate hepatic impairment (Child-Pugh [CP]/ Child-Turcotte-Pugh [CTP] Class B) AND the total duration of treatment with the requested strength has NOT exceeded 24 months per lifetime OR 2. The patient does have coexisting moderate hepatic impairment (Child-Pugh [CP]/ Child-Turcotte-Pugh [CTP] Class B) AND the total duration of treatment with the requested strength has NOT exceeded 6 months per lifetime

Approval duration

BCBSIL/BCBSTX:12 months; others:up to 6 months (≥3 months for MT/NM); lifetime max per strength as stated