Xeljanz — Blue Cross Blue Shield of Montana

Initial criteria

• A. The requested dose has been previously approved and is a continuation of therapy (same dose and quantity) OR
• B. For adalimumab 40 mg weekly for RA or Crohn’s disease: patient has failed adalimumab 40 mg every other week OR
• C. For Xeljanz/Xeljanz XR and UC: BOTH of the following: 1) Support for therapy for the dose exceeding the quantity limit (e.g., loss of response to FDA labeled maintenance dose) (medical records required); AND 2) Requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does NOT exceed the program quantity limit OR
• D. For Xeljanz oral solution and pcJIA: ONE of the following: 1) BOTH of the following: A) Requested dose does NOT exceed maximum FDA labeled dose (5 mg BID) for the indication; AND B) Support for why patient cannot take Xeljanz 5 mg tablets OR 2) ALL of the following: A) Requested dose exceeds the FDA maximum labeled dose; AND B) Patient has tried and had an inadequate response to ≥3 months of therapy at the maximum FDA labeled dose (medical records required); AND C) ONE of the following: (1) BOTH of the following: (A) Requested dose does NOT exceed maximum compendia supported dose for the indication; AND (B) Requested dose cannot be achieved with a lower quantity of a higher strength and/or package size that does NOT exceed the program quantity limit OR (2) BOTH of the following: (A) Requested dose exceeds the maximum FDA labeled and compendia supported dose; AND (B) Support for therapy with a higher dose (copy of clinical trials, phase III studies, or guidelines required) OR
• E. For agents not described above: ONE of the following: (1) FDA labeled indication: A) BOTH of the following: (1) Requested dose does NOT exceed the maximum FDA labeled dose; AND (2) Requested quantity cannot be achieved with lower quantity of a higher strength/package size OR B) ALL of the following: (1) Requested dose exceeds FDA maximum labeled; AND (2) Patient has tried ≥3 months at the maximum labeled dose (medical records required); AND (3) ONE of the following: (A) Requested dose does NOT exceed compendia supported maximum and cannot be achieved with lower quantity; OR (B) Requested dose exceeds both FDA labeled and compendia supported and there is support for higher dosing (copy of trials, studies, or guidelines required) OR (2) Compendia supported indication: A) BOTH of the following: (1) Requested dose does NOT exceed maximum compendia supported; AND (2) Requested quantity cannot be achieved with a lower strength/package size OR B) BOTH of the following: (1) Requested dose exceeds maximum compendia supported; AND (2) Support for therapy with higher dose or shortened dosing interval (copy of trials, phase III studies, or guidelines required) OR (3) Indications not FDA labeled nor compendia supported: BOTH of the following: A) Requested quantity cannot be achieved with lower strength/package size; AND B) Support for therapy with higher dose or shortened interval (copy of trials, studies, or guidelines required)

Reauthorization criteria

• Continuation of therapy at same dose and quantity (previously approved dose).

Approval duration

12 months