Pharmacy Prior Authorization Criteria

Xeljanz, Xeljanz XR (tofacitinib)

Indications for Prior Authorization

Xeljanz (tofacitinib) tablets, Xeljanz XR (tofacitinib) extended-release tablets

• For diagnosis of Rheumatoid Arthritis (RA)
  Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

  Limitations of Use: Use of Xeljanz/Xeljanz XR in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

• For diagnosis of Psoriatic Arthritis (PsA)
  Indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

  Limitations of Use: Use of Xeljanz/Xeljanz XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

• For diagnosis of Ankylosing Spondylitis (AS)
  Indicated for the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.

  Limitations of Use: Use of Xeljanz/Xeljanz XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

• For diagnosis of Ulcerative Colitis (UC)
  Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis, who have an inadequate response or intolerance to one or more TNF blockers.

  Limitations of Use: Use of Xeljanz/Xeljanz XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Xeljanz (tofacitinib) tablets and oral solution

• For diagnosis of Polyarticular Course Juvenile Idiopathic Arthritis
  Indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.

  Limitations of Use: Use of Xeljanz in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Criteria

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Diagnosis of moderately to severely active rheumatoid arthritis
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [2, 3]:
• methotrexate
• leflunomide
• sulfasalazine
AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab)
AND
• Not used in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets and oral solution

*Xeljanz may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Diagnosis of active polyarticular course juvenile idiopathic arthritis
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [4]:
• leflunomide
• methotrexate
AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, etanercept)
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets and oral solution

*Xeljanz may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Diagnosis of active psoriatic arthritis (PsA)
AND
• One of the following [5]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist
AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab)
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
• Reduction in the body surface area (BSA) involvement from baseline
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Diagnosis of active ankylosing spondylitis
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses [6]
AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab)
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 6]:
• Disease activity (e.g., pain, fatigue, inflammation, stiffness)
• Lab values (erythrocyte sedimentation rate, C-reactive protein level)
• Function
• Axial status (e.g., lumbar spine motion, chest expansion)
• Total active (swollen and tender) joint count
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Initial Authorization)

Length of Approval: 4 Months [A]
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• One of the following [7, 8]:
• Greater than 6 stools per day
• Frequent blood in the stools
• Frequent urgency
• Presence of ulcers
• Abnormal lab values (e.g., hemoglobin, ESR, CRP)
• Dependent on, or refractory to, corticosteroids
AND
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies [7, 8]:
• 6-mercaptopurine
• Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
• Azathioprine
• Corticosteroids (e.g., prednisone)
AND
• Prescribed by or in consultation with a gastroenterologist
AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, golimumab)
AND
• Not used in combination with other JAK inhibitors, biological therapies for UC, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

Xeljanz tablets or Xeljanz XR tablets

*Xeljanz/Xeljanz XR may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 7, 8]:
• Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
• Reversal of high fecal output state
AND
• Not used in combination with other JAK inhibitors, biological therapies for UC, or potent immunosuppressants (e.g., azathioprine, cyclosporine)*

P & T Revisions

2024-09-15, 2023-11-05, 2023-10-04, 2023-07-06, 2023-02-01, 2022-10-24, 2022-09-07, 2022-06-02, 2022-05-17, 2022-05-08, 2022-04-22, 2022-03-08, 2021-09-03, 2021-05-25, 2021-02-28, 2020-12-03, 2020-09-02, 2020-05-01, 2020-01-27, 2019-10-31

References

1. Xeljanz, Xeljanz XR Prescribing Information. Pfizer, Inc. New York, NY. May 2024.
2. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
3. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
4. Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863.
5. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
6. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613.
7. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol 2019;114:384–413.
8. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.

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Revision History

• 2024-09-15: Annual review - no criteria changes; background updates
• 2023-11-05: 12/1/23: Annual review - addition of "other JAK inhibitors" to criteria warning against concomitant use. 1/1/24: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
• 2023-07-06: Updated examples of TNF inhibitors to list generic names
• 2023-02-01: Addition of Amjevita as another TNF inhibitor example
• 2022-10-24: PJIA - step through Humira removed and criteria has been updated to align with the prescribing information of inadequate response or intolerance to a TNF inhibitor. Further clinical detail and criteria added
• 2022-09-07: Annual review - no criteria changes
• 2022-06-02: Removal of embedded biologic steps for AS; addition of a general criterion for AS regarding inadequate response or intolerance to one or more TNF inhibitors. Updated the concomitant use criteria for other indications to align with the label; background updates
• 2022-05-17: Removal of embedded biologic steps for UC; addition of a general criterion regarding inadequate response or intolerance to one or more TNF inhibitors.
• 2022-05-08: Removal of embedded biologic steps for UC; addition of a general criterion regarding inadequate response or intolerance to one or more TNF inhibitors.
• 2022-04-22: Removal of embedded biologic steps for UC; addition of a general criterion regarding inadequate response or intolerance to one or more TNF inhibitors.
• 2022-03-08: Added criteria for new AS indication; removed biologic steps for PsA; removed needle phobia bypass for PJIA and UC steps; added a criterion for RA and PsA for a trial of a TNF inhibitor based on the updated indication
• 2021-09-03: Annual review
• 2021-05-25: Addition of EHB formulary. No changes to criteria
• 2021-02-28: Addition of Xeljanz solution GPI
• 2020-12-03: Addition of criteria for new PJIA indication
• 2020-09-02: Addition of Tremfya as a preferred step option for psoriatic arthritis; formulary strategy updates to remove Simponi Aria as a preferred step option for PsA and remove infliximab as a preferred step for UC; Annual review - background and reference updates
• 2020-05-01: Removed nonbiologic DMARD requirement in PsA criteria to align with criteria for other biologic immunomodulators and recommendations from the ACR/NPF clinical guidelines.
• 2020-01-27: Addition of Xeljanz XR 22 mg GPI, and addition of Xeljanz XR to the UC indication and criteria.
• 2019-10-31: Added Stelara and infliximab as step options for UC; changed UC step through 2 first line agents instead of 1 agent.

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