relugolix — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Member resides in Ohio
• Plan is Fully Insured or HIM Shop (SG)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• ONE of the following: - Patient has another FDA labeled indication for the requested agent and route of administration OR - Patient has another indication that is supported in compendia for the requested agent and route of administration OR - Prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective; accepted study designs may include randomized, double blind, placebo controlled clinical trials; case studies not acceptable

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient is premenopausal (e.g., less than 12 months since last menstrual period)
• Patient has had clinical benefit with the requested agent
• Patient’s bone health has been assessed AND allows for continued therapy with the requested agent
• Patient has NOT had a fragility fracture since starting therapy with the requested agent
• 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
• 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. The total duration of treatment with the requested agent has NOT exceeded 24 months per lifetime

Approval duration

12 months (BCBSIL and BCBSTX); up to 6 months for others with lifetime max 24 months