CurrentCignaPolicy IP0692

Xeljanz/Xeljanz XR Prior Authorization Policy

Defines prior authorization requirements, clinical criteria for initial and continuation approval, covered FDA indications (ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis), excluded uses and combination restrictions, and appendix of comparator biologics/other targeted therapies for Cigna benefit plans.

Policy Summary

PayerCigna

PolicyXeljanz/Xeljanz XR Prior Authorization Policy

Policy CodePolicy IP0692

Change TypeRevisions & Annual Review

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization; initial approvals require specialist prescribing or consultation and use of preferred products per referenced PSM policies.

SourceLink

POLICY UPDATE CHANGES

Psoriatic Arthritis: Separated products approved based on age; added approval option for Xeljanz immediate-release tablets and oral solution in patients > 2 years and specified Xeljanz XR approval is for patients > 18 years.

Annual revision noted with no criteria changes on 06/01/2025.

New policy created with summary of changes on 11/01/2024.

5FDA-Approved Indications Covered

3Not Covered Combination Categories

6Continuation approval requirement (months)

Coverage Summary

Coverage stance: covered_with_criteria. The policy defines prior authorization requirements, clinical criteria for initial and continuation approval, and specialist prescriber requirements for Xeljanz/Xeljanz XR as summarized in the scope.

Covered FDA indications (5): ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

General prior authorization and prescriber requirements: Prior Authorization is required for benefit coverage and initial approval must be prescribed by or in consultation with a specialist in the condition being treated (e.g., rheumatologist, dermatologist, or gastroenterologist as applicable). Use of preferred products per referenced PSM policies is required before approval.

Not medically necessary / excluded uses include: concurrent use with another biologic or targeted synthetic oral small molecule drug (combination therapy), concurrent use with other potent immunosuppressants (examples: azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil), and use for renal transplantation (insufficient data and safety concerns).

Quick Facts / Thresholds

Initial TNFi trial3-month trial of at least ONE TNFi required for initial approval

Continuation (established therapy)Patient established on therapy ≥ 6 months for continuation approval

FDA-Approved Indications Covered5

Not Covered Combination Categories3 (concurrent biologic, other potent immunosuppressant, renal transplant)

Specialist prescriber requirementInitial approval requires prescription by or consultation with a specialist in the treated condition

Prior Authorization & Provider Requirements

Prior Authorization

Submit prior authorization

Prior Authorization is required for Xeljanz/Xeljanz XR; initial approvals require specialist prescribing or specialist consultation and use of preferred products per referenced PSM policies.

Documentation Required

Document prior TNFi therapy or intolerance

For initial therapy approvals, document a 3-month trial of at least one tumor necrosis factor inhibitor or inability to tolerate a 3-month trial. Conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) do not count as TNFi trials.

Documentation Required

Document clinical response for continuation

For patients currently receiving therapy, document at least 6 months of prior therapy and evidence of beneficial clinical response from baseline or improvement in at least one symptom. Examples of objective measures include standardized disease activity scores and serum markers depending on the indication (e.g., ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ‑S, CRP, ESR for ankylosing spondylitis; MD global, PGA, PDA, JDAS, cJDAS, JSpADA, CRP, ESR, reduced corticosteroid dose for JIA; DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis, MDA, PsAID‑12, CRP, ESR for psoriatic arthritis; CDAI, DAS28‑ESR/CRP, PAS‑II, RAPID‑3, SDAI for RA; fecal calprotectin, serum CRP, endoscopic assessment, reduced corticosteroid dose for UC).

Denial Risk

Combination therapy prohibition

Requests for concurrent use of Xeljanz/Xeljanz XR with another biologic or targeted synthetic oral small molecule for an inflammatory condition, with other potent immunosuppressants (e.g., azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil), or for renal transplantation are considered not medically necessary and will be denied.

Ankylosing Spondylitis — Initial & Continuation Criteria

Covered when ALL of the following are met:

ALL of the following

General prior authorization and prescriber requirement: Prior Authorization is required. The medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (rheumatologist).
Prescriber requirement applies to initial approvals.
A) Initial Therapy
- ALL of the following
  - Approve for 6 months.
    Approval duration = 6 months (1 month = 30 days).
  - Patient is ≥ 18 years of age.
  - ANY of the following
    Patient has had a 3-month trial of at least ONE tumor necrosis factor inhibitor (TNFi).
    Patient tried at least one TNFi but was unable to tolerate a 3-month trial.
  - Medication is prescribed by or in consultation with a rheumatologist.
B) Currently Receiving
- ALL of the following
  - Approve for 1 year.
    Approval duration = 1 year.
  - Patient has been established on therapy for at least 6 months.
  - ANY of the following
    When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, or serum markers such as CRP or ESR).
    Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).

Juvenile Idiopathic Arthritis (JIA) — Initial & Continuation Criteria

Juvenile Idiopathic Arthritis (JIA) - FDA-Approved Indications

Approve Xeljanz tablets (not XR) or oral solution for the duration noted if the patient meets ONE of the following (A or B):

JIA criteria

A) Initial Therapy: Approve for 6 months; patient is > 2 years of age; patient has had a 3-month trial of at least one TNFi OR tried a TNFi but was unable to tolerate a 3-month trial; medication prescribed by or in consultation with a rheumatologist3-month TNFi trial
Conventional synthetic DMARDs do not count as TNFi trials
B) Currently Receiving: Approve for 1 year; patient has been established on therapy for at least 6 months; and either when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline OR the patient experienced improvement in at least one symptom (motion, pain, morning stiffness, fatigue, function/ADLs)established ≥ 6 months
Examples of objective measures: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, CRP, ESR, reduced corticosteroid dose

Note: A patient who has received < 6 months of therapy or who is restarting therapy with Xeljanz is reviewed under Initial Therapy.

Psoriatic Arthritis — Initial & Continuation Criteria

Psoriatic Arthritis - FDA-Approved Indications

Approve for the duration noted if the patient meets ONE of the following (A or B):

Psoriatic Arthritis criteria

A) Initial Therapy: Approve for 6 months; if immediate-release tablets or oral solution requested patient is ≥ 2 years of age OR if Xeljanz XR requested patient is ≥ 18 years of age; patient has had a 3-month trial of at least ONE TNFi OR tried a TNFi but was unable to tolerate a 3-month trial; medication will be used in combination with methotrexate or another conventional synthetic DMARD unless contraindicated; medication prescribed by or in consultation with a rheumatologist or dermatologist3-month TNFi trial; combination with methotrexate or other csDMARD unless contraindicated
Examples of other conventional synthetic DMARDs include leflunomide and sulfasalazine
B) Currently Receiving: Approve for 1 year; patient has been established on therapy for at least 6 months; medication will be used in combination with methotrexate or another conventional synthetic DMARD unless contraindicated; and either when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline OR the patient experienced improvement in at least one symptom (less joint pain, morning stiffness, fatigue, improved function/ADLs, decreased soft tissue swelling)established ≥ 6 months
Examples of objective measures: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis, MDA, PsAID-12, CRP, ESR

Note: A patient who has received < 6 months of therapy or who is restarting therapy with Xeljanz/Xeljanz XR is reviewed under Initial Therapy.

Rheumatoid Arthritis — Initial & Continuation Criteria

Rheumatoid Arthritis - FDA-Approved Indications

Approve Xeljanz/Xeljanz XR tablets (not oral solution) for the duration noted if the patient meets ONE of the following (A or B):

Rheumatoid Arthritis criteria

A) Initial Therapy: Approve for 6 months; patient is ≥ 18 years of age; patient has had a 3-month trial of at least ONE TNFi OR tried a TNFi but was unable to tolerate a 3-month trial; medication prescribed by or in consultation with a rheumatologist3-month TNFi trial
Conventional synthetic DMARDs do not count as TNFi trials
B) Currently Receiving: Approve for 1 year; patient has been established on therapy for at least 6 months; and either the patient experienced a beneficial clinical response when assessed by at least one objective measure OR the patient experienced an improvement in at least one symptom (decreased joint pain, morning stiffness, fatigue, improved function/ADLs, decreased soft tissue swelling)established ≥ 6 months
Examples of objective measures: CDAI, DAS28-ESR or CRP, PAS-II, RAPID-3, SDAI

Note: A patient who has received < 6 months of therapy or who is restarting therapy with Xeljanz/Xeljanz XR is reviewed under Initial Therapy.

Ulcerative Colitis — Initial & Continuation Criteria

Ulcerative Colitis - FDA-Approved Indications

Approve Xeljanz/Xeljanz XR tablets (not oral solution) for the duration noted if the patient meets ONE of the following (A or B):

Ulcerative Colitis criteria

A) Initial Therapy: Approve for 6 months; patient is ≥ 18 years of age; patient has had a 3-month trial of at least ONE TNFi OR tried a TNFi but was unable to tolerate a 3-month trial; medication prescribed by or in consultation with a gastroenterologist3-month TNFi trial
Conventional synthetic DMARDs do not count as TNFi trials
B) Currently Receiving: Approve for 1 year; patient has been established on therapy for at least 6 months; and either when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline OR the patient experienced improvement in at least one symptom (decreased pain, fatigue, stool frequency, decreased rectal bleeding)established ≥ 6 months
Examples of objective measures: fecal calprotectin, serum CRP, endoscopic assessment, reduced corticosteroid dose

Note: A patient who has received < 6 months of therapy or who is restarting therapy with Xeljanz/Xeljanz XR is reviewed under Initial Therapy.

Clinical Evidence & Background

Background: Xeljanz/Xeljanz XR (tofacitinib) is an oral Janus kinase (JAK) inhibitor approved for multiple inflammatory conditions; the policy aligns coverage and specialist prescriber requirements with FDA-approved indications and product labeling.

The policy references professional clinical practice guidelines for these conditions (e.g., ACR, AGA, ACG) that describe how JAK inhibitors fit into treatment algorithms and support use in selected patients.

Prescribing information: Pfizer Xeljanz / Xeljanz XR prescribing information (October 2025) is cited as the source of product approvals, formulations, age limits, and safety recommendations.

Definitions

TNFi (term)Tumor necrosis factor inhibitor; examples listed in Appendix (adalimumab, certolizumab, etanercept, infliximab, golimumab, etc.). Conventional synthetic DMARDs do not count as TNFi.

Revision History

11/01/2024initial_creation

New policy created (initial policy).

06/01/2025annual_revision

Annual revision noted with no criteria changes.

10/15/2025material_revisionLatest

Material revision: Psoriatic Arthritis — separated product approvals by age; added approval option for Xeljanz immediate‑release tablets and oral solution in patients ≥ 2 years and specified Xeljanz XR approval for patients ≥ 18 years.

OpenPayer

Xeljanz/Xeljanz XR Prior Authorization Policy

Coverage Summary

Prior Authorization & Provider Requirements

Ankylosing Spondylitis — Initial & Continuation Criteria

Juvenile Idiopathic Arthritis (JIA) — Initial & Continuation Criteria

Psoriatic Arthritis — Initial & Continuation Criteria

Rheumatoid Arthritis — Initial & Continuation Criteria

Ulcerative Colitis — Initial & Continuation Criteria

Exclusions / Not Medically Necessary

Applicable Codes

Clinical Evidence & Background

Revision History