XELJANZ/XELJANZ XR (tofacitinib)

XELJANZ (tofacitinib); XELJANZ XR (tofacitinib extended release)

Self-Administration - oral tablet, oral extended-release tablet, oral solution

 

Indications for Prior Authorization:

 

Xeljanz tablet and Xeljanz XR tablet

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. 

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. 

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. 

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 tablet and Xeljanz oral solution

Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA): 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.

 

Coverage Criteria:

 

For diagnosis of Rheumatoid Arthritis (RA):

• Documented diagnosis of moderately to severely active RA; 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: 
  • methotrexate 
  • leflunomide 
  • sulfasalazine
  • hydroxychloroquine; AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., Cimzia, Enbrel, Humira, Simponi); AND
• Not used in combination with biologic DMARDs or potent immunosuppressants (e.g., azathioprine or cyclosporine) *

 

For diagnosis of Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA):

• Documented diagnosis of active pcJIA (or PJIA); AND
• The request is for Xeljanz oral solution or Xeljanz tablet; 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: 
  • methotrexate 
  • leflunomide 
  • sulfasalazine; AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., Enbrel, Humira); AND
• Not used in combination with biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine. *

 

For diagnosis of psoriatic arthritis (PsA):

• Documented diagnosis of active PsA; AND
• Prescribed by or in consultation with a dermatologist or rheumatologist; AND
• One of the following:
  • actively inflamed joints 
  • dactylitis 
  • enthesitis 
  • axial disease 
  • active skin and/or nail involvement; AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., Cimzia, Enbrel, Humira, Simponi); AND
• Not used in combination with biologic DMARDs or potent immunosuppressants (e.g., azathioprine or cyclosporine). *

 

For diagnosis of ankylosing spondylitis (AS):

• Documented diagnosis of active AS; AND
• Prescribed by or in consultation with a rheumatologist; AND
• Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., Cimzia, Enbrel, Humira, Simponi); AND
• Not used in combination with biologic DMARDs or potent immunosuppressants (e.g., azathioprine or cyclosporine). *

 

For diagnosis of Ulcerative Colitis (UC):

• Diagnosis of moderately to severely active UC; AND
• Diagnosis confirmed by a gastroenterologist; AND
• One of the following:
  • 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:
  • 6-mercaptopurine
  • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
  • azathioprine
  • corticosteroids (e.g., prednisone, methylprednisolone, budesonide); AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., Humira, Simponi); AND
• Not used in combination with biological therapies for UC or potent immunosuppressants (e.g., azathioprine or cyclosporine). *

*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).

 

Reauthorization Criteria:

 

For diagnosis of RA, pcJIA (or PJIA):

• Documentation of positive clinical response to therapy as evidenced by at least one of the following:
  • 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 biologic DMARDs or potent immunosuppressants (e.g., azathioprine or cyclosporine). *  

 

For diagnosis of PsA:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
  • 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 biologic DMARDs or potent immunosuppressants (e.g., azathioprine or cyclosporine). *  

 

For diagnosis of AS:

• Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
  • 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 biologic DMARDs or potent immunosuppressants (e.g., azathioprine or cyclosporine). *   

 

For diagnosis of UC:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
  • 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 biologic DMARDs or potent immunosuppressants (e.g., azathioprine or cyclosporine). *   

*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).

 

Dosing:

 

RA, PsA, AS (adults): 

• XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily.

 

UC (adults):

• Induction: XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily for 8 weeks. 
  • If needed, continue XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily for a maximum of 16 weeks. 
  • Discontinue XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
• Maintenance: XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily. 
  • For patients with loss of response during maintenance treatment, XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. 
  • Use the lowest effective dose needed to maintain response.

 

pcJIA (or PJIA) (pediatrics, 2 years of age and older):

• Xeljanz Oral Solution or Oral Tablets or weight-based equivalent twice daily.
  • 10 kg to less than 20 kg: 3.2 mg (3.2 mL oral solution) twice daily
  • 20 kg to less than 40 kg: 4 mg (4 mL oral solution) twice daily
  • 40 kg or greater: 5 mg (one 5 mg tablet or 5 mL oral solution) twice daily

 

Coverage Duration:

 

For diagnosis of RA, PsA, pcJIA, AS:

• Initial: 1 year
• Reauthorization: 1 year

For diagnosis of UC:

• Initial: 4 months
  • Discontinue Xeljanz after 16 weeks if adequate therapeutic response is not achieved.
• Reauthorization: 1 year

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:

• Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during administration of Xeljanz/Xeljanz XR. 
• Coadministration of strong CYP3A4 inducers (e.g. rifampin) with Xeljanz/Xeljanz XR is not recommended.
• Avoid use of Xeljanz/Xeljanz XR in patients with an active, serious infection, including localized infections.
• Avoid Xeljanz/Xeljanz XR in patients that may be at increased risk of thrombosis.
• Avoid initiation of Xeljanz/Xeljanz XR treatment in patients with a low lymphocyte count (i.e., less than 500 cells/mm3), low neutrophil count (i.e., ANC less than 1,000 cells/mm3), or low hemoglobin level (i.e., less than 9 g/dL).

 

Review History:

• 02/18/2020- Criteria updated.
• 07/01/2020- Criteria updated.
• 12/11/2020- Annual review. Criteria and format updated.
• 04/20/2021- Criteria updated to include new indication. Duration of initial approval updated for psoriatic arthritis.
• 07/26/2021- Format updated.
• 11/16/2021 - Updated Juvenile Idiopathic Arthritis (JIA) oral disease-modifying anti-rheumatic drugs [DMARDs] criteria
• 04/05/2022- Updated criteria.  Addition of criteria for the trial and failure of one or more TNF inhibitors due to the JAK safety update
• 07/05/2022 - Updated criteria for UC - removed failure of two preferred agents; changed to failure of one or more TNF inhibitors (e.g., Humira, Simponi). 
• 08/16/2022 - Updated AS criteria to be consistent with the FDA-approved indication.
• 01/01/2023 - Update prerequisite drugs for RA, pcJIA, PsA, AS; add symptom requirements for PsA, UC. add reauthorization criteria for all indications.

 

References:

1. Xeljanz, Xeljanz XR Prescribing Information. Pfizer, Inc. New York, NY. January 2022. 
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.