Xifaxan 550mg — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of irritable bowel syndrome with diarrhea (IBS-D) AND ALL 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 being treated with and is 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 agent was discontinued due to lack of efficacy/effectiveness or adverse event [chart notes required] OR
• d. The patient has intolerance or hypersensitivity to ONE tricyclic antidepressant agent [chart notes required] OR
• e. The patient has an FDA-labeled contraindication to ONE tricyclic antidepressant agent [chart notes required] OR
• f. ONE tricyclic antidepressant agent is expected to be ineffective based on known clinical characteristics or cause significant barrier/adverse effect [chart notes required] OR
• g. ONE tricyclic antidepressant agent is not in the patient’s best interest 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 agent and discontinued due to lack of efficacy/effectiveness or adverse event [chart notes required]
• B. The patient is at risk of recurrent overt hepatic encephalopathy OR
• C. The patient has another FDA labeled indication for the requested agent OR
• D. The patient has another indication supported in compendia for the requested agent and route of administration
• 2. If patient has an FDA labeled indication, then ONE of the following:
• A. Patient’s age is within FDA labeling for the requested indication OR
• B. There is support for using the requested agent for the patient’s age for the requested indication
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent
• Compendia Allowed: AHFS or DrugDex 1, 2A, or 2B level of evidence, or NCCN 1, 2A or 2B

Reauthorization criteria

• 1. The patient has been previously approved through the plan’s prior authorization process AND
• 2. ONE of the following:
• A. The patient has a diagnosis of IBS-D AND 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 OR
• B. The patient is at risk of recurrent overt hepatic encephalopathy AND has had clinical benefit with the requested agent OR
• C. The patient has another FDA labeled indication for the requested agent AND has had clinical benefit with the requested agent OR
• D. The patient has another indication supported in compendia for the requested agent and route of administration AND has had clinical benefit with the requested agent
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent
• Compendia Allowed: AHFS or DrugDex 1, 2A, or 2B level of evidence, or NCCN 1, 2A or 2B

Approval duration

IBS-D: BCBSIL 12 months; BCBSMT and BCBSNM 3 months; all other plans 1 month; hepatic encephalopathy 12 months; other indications 12 months