Oriahnn — Blue Cross Blue Shield of Montana

Initial criteria

• 1. The patient has a diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
• 2. The patient’s diagnosis of uterine fibroids was confirmed via imaging (e.g., ultrasound)
• 3. The patient has NOT had a hysterectomy
• 4. The patient is premenopausal (e.g., less than 12 months since last menstrual period)
• 5. The patient’s bone health has been assessed AND allows for initiating therapy with the requested agent
• 6. 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 OR C. The patient has an FDA labeled contraindication to ALL prerequisite therapies (i.e., hormonal contraceptives, NSAIDs including COX-II inhibitors)
• 7. 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
• 8. The patient does NOT have any FDA labeled contraindications to the requested agent
• 9. ONE of the following: A. The patient is initiating therapy with the requested agent OR B. The patient is not initiating therapy 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 agent has NOT exceeded 24 months per lifetime

Approval duration

not stated yet (continues on next page)