Rifaximin 550mg — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of irritable bowel syndrome with diarrhea (IBS-D) AND BOTH of the following: 1. The patient has NOT received 3 or more 14-day treatment courses in the previous 12 months AND 2. ONE of the following: (a) The patient is currently stable on the requested agent [chart notes required] OR (b) The patient has tried and had an inadequate response to ONE tricyclic antidepressant agent [chart notes required] OR (c) ONE tricyclic antidepressant was discontinued due to lack of efficacy/effectiveness or an adverse event [chart notes required] OR (d) The patient has an intolerance or hypersensitivity to ONE tricyclic antidepressant agent (not expected to occur with the requested agent) [chart notes required] OR (e) The patient has an FDA labeled contraindication to ONE tricyclic antidepressant agent (not expected to occur with the requested agent) [chart notes required] OR (f) ONE tricyclic antidepressant is expected to be ineffective or cause barriers/adverse reactions based on clinical characteristics [chart notes required] OR (g) ONE tricyclic antidepressant is not in the best interest of the patient based on medical necessity [chart notes required] OR (h) The patient has tried another prescription drug in the same pharmacologic class or mechanism as a tricyclic antidepressant and discontinued due to lack of efficacy or adverse event [chart notes required]
• B. The patient is at risk of recurrent overt hepatic encephalopathy
• C. The patient has another FDA labeled indication for the requested agent
• D. The patient has another indication supported in compendia (AHFS or DrugDex 1, 2A, or 2B; NCCN 1, 2A, or 2B) for the requested agent and route of administration
• If the patient has an FDA labeled indication, ONE of the following: (A) The patient’s age is within FDA labeling OR (B) There is support for use at patient’s age
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• ONE of the following:
• A. For IBS-D: ALL of the following: (1) The patient has had clinical benefit with the requested agent AND (2) The patient had a treatment-free period AND (3) The patient has NOT received 3 or more 14-day treatment courses in the previous 12 months
• B. The patient is at risk of recurrent overt hepatic encephalopathy AND has had clinical benefit with the requested agent
• C. The patient has another FDA labeled indication AND has had clinical benefit with the requested agent
• D. The patient has another compendia-supported indication AND has had clinical benefit with the requested agent
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

IBS-D: 3 months (BCBSMT, BCBSNM), 12 months (BCBSIL), 1 month (others); Hepatic encephalopathy: 12 months; Other indications: 12 months