Oriahnn — Blue Cross Blue Shield of Alabama

Initial criteria

• The patient has a diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
• The patient’s diagnosis of uterine fibroids was confirmed via imaging (e.g., ultrasound)
• The patient has NOT had a hysterectomy
• The patient is premenopausal (e.g., less than 12 months since last menstrual period)
• The patient’s bone health has been assessed AND allows for initiating therapy with the requested agent
• ONE of the following: • 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 • 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 • The patient has an FDA labeled contraindication to ALL prerequisite therapies (i.e., hormonal contraceptives [oral, topical patches, implants, injections, IUD], NSAIDs [including COX-II inhibitors]) used in the treatment of the requested indication
• 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: • The patient is initiating therapy with the requested agent OR • The patient is not initiating therapy with the requested agent and BOTH of the following: – There is support confirming the number of months the patient has been on therapy – The total duration of treatment with the requested agent has NOT exceeded 24 months per lifetime

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 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) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent
• BOTH of the following: • There is support confirming the number of months the patient has been on therapy • The total duration of treatment with the requested agent has NOT exceeded 24 months per lifetime

Approval duration

6 months (lifetime maximum 24 months)