Tofacitinib (Xeljanz, Xeljanz XR) coverage
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Defines medical necessity, prior authorization, and continuation criteria for tofacitinib (Xeljanz and Xeljanz XR) for Delaware First Health (Medicaid) members across approved indications. Affects prescribers and PA reviewers handling tofacitinib requests.
For UC initial criteria, added option for documentation of modified Mayo Score ≥ 5 and Mayo Endoscopic Score > 2 to define moderate-to-severe UC.
Removed examples of preferred adalimumab products because adalimumab is not recommended due to low efficacy per 2024 AGA guidelines.
Added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent.
Applied pediatric age extension for PsA per updated FDA labeling and extended initial approval duration to 12 months for chronic indications.
Coverage and Medical Necessity Criteria
Initial Therapy — pcJIA
Initial Approval — Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA): covered when ALL of the following are met
See Appendix D for MTX contraindications; TNF blockers may require prior authorization.
Initial Therapy — Psoriatic Arthritis
Initial Approval — Psoriatic Arthritis (PsA): covered when ALL of the following are met
Prior authorization may be required for TNF blockers; pediatric Xeljanz use noted.
Initial Therapy — Rheumatoid Arthritis
Initial Approval — Rheumatoid Arthritis (RA): covered when ALL of the following are met
See Appendices for CDAI/RAPID3 scoring.
Initial Therapy — Ulcerative Colitis
Initial Approval — Ulcerative Colitis (UC): covered when ALL of the following are met
Prior authorization may be required for TNF blockers; see Appendix E for scoring details.
Initial Therapy — Ankylosing Spondylitis
Initial Approval — Ankylosing Spondylitis (AS): covered when ALL of the following are met
Prior authorization may be required for TNF blockers.
Continuation Therapy
Continuation Therapy — All Indications in Section I: covered when ALL of the following are met
Approval duration is 12 months.
Indication-specific dosing and duration
Dosing and treatment duration notes by indication
Documented in dosing section.
Documented in dosing section.
Documented in dosing section.
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP.PMN.53 or other applicable evidence‑of‑coverage documentation.
Requests for uses that fall outside the FDA‑approved indications listed in this policy will be denied unless the submission includes supportive clinical documentation per off‑label policy CP.PMN.53 or other evidence of coverage. The policy explicitly requires such documentation to consider non‑FDA uses for potential authorization.
The policy reiterates that combination use of tofacitinib with a biologic disease‑modifying antirheumatic drug (bDMARD) or another Janus kinase (JAK) inhibitor is prohibited and this requirement has been applied across Sections I and II of the criteria set.
Combination therapy with a biologic DMARD or another JAK inhibitor is listed as a condition where coverage is not authorized. The policy notes that use with bDMARDs or other potent immunosuppressants is not recommended because of additive immunosuppression and increased infection risk.
Use of tofacitinib in combination with biological DMARDs or other potent immunosuppressants (examples provided in the policy) is considered not authorized due to the increased risk of neutropenia, serious infections, and additive immunosuppression.
The policy consistently restates that concurrent use of tofacitinib with a bDMARD or another JAK inhibitor is not allowed. This prohibition is reiterated in multiple sections and was carried forward during recent updates to the criteria and appendices.
Initial Therapy Requirements and Dosing
Initial therapy requirements
Initial approval requires meeting the indication-specific criteria including prescriber specialty, age, prior therapy trials/failures, disease severity assessments (where applicable), and dosing limits.
Initial dosing
Dosing by indication and weight where provided.
Initial therapy criteria (dosing and disease activity documentation)
Initial dosing and disease activity documentation requirements (partial content in other sections).
From dosing and revisions sections.
Continuation and Reauthorization Criteria
Continuation Therapy
Continuation therapy requirements mirror initial criteria and require clinical response.
Continuation therapy and authorization duration notes
Continuation and authorization duration notes
From Reviews, Revisions, and Approvals.
Required Prior Therapy Trials and Alternatives
| Indication | Required prior trials/failures (per policy) | Notes / duration |
|---|---|---|
| Polyarticular-course juvenile idiopathic arthritis (pcJIA) | ||
| Failure of ≥3 consecutive month trial of methotrexate at up to maximally indicated doses; OR MTX intolerance/contraindication plus failure of ≥3 month trial of leflunomide or sulfasalazine; OR for sacroiliitis/axial involvement failure of ≥4 week NSAID trial; OR documentation of high disease activity; Member has not responded or is intolerant to ≥1 TNF blocker unless contraindicated | ||
| See Appendix D for MTX contraindications; TNF blockers may require prior authorization. Initial approval duration for chronic indications = 12 months; bypass of conventional therapies allowed if member has failed a biologic agent (per 2Q2025 update) |
| Content | Details / examples |
|---|---|
| Therapeutic alternatives listed in Appendix B | |
| Appendix B provides a listing of preferred alternative therapies (DMARDs and TNF blockers). Appendix D lists TNF blockers (etanercept, adalimumab and biosimilars, infliximab and biosimilars, certolizumab, golimumab) as examples; these agents may be preferred prior therapies and may require prior authorization. |
| Topic | Policy statement / examples |
|---|---|
| Place in therapy after TNF inhibitors (TNFi) | |
| Policy updated place in therapy after TNFi per FDA labeling: most indications require prior failure or intolerance to ≥1 TNF blocker unless contraindicated; 2Q2022 and subsequent updates clarified TNFi place in therapy. |
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required — show member meets initial approval criteria
Prior authorization is required for tofacitinib. The provider must demonstrate the member meets the indication-specific initial approval criteria including diagnosis, prescriber specialty/consultation, required prior therapy trials or documented reasons for not using them, dosing limits, and absence of prohibited combination therapy.
- Show diagnosis and prescriber specialty or consultation per indication (e.g., rheumatologist for RA/AS/pcJIA; gastroenterologist for UC).
- Provide prior therapy trial documentation as required by the indication (e.g., MTX or other DMARDs, TNF blocker failure or intolerance where specified).
- Confirm requested dose does not exceed indication-specific maximums.
Denial risks — non‑FDA indications and prohibited combination therapy
Requests for uses not described in this policy (non‑FDA indications) or requests that involve combination therapy with a biologic DMARD or other potent immunosuppressant/JAK inhibitor are at high risk for denial unless the off‑label use policy criteria are met; combination use is explicitly not authorized.
- Non‑FDA indications: submit sufficient documentation per off‑label policy CP.PMN.53 or evidence of coverage to support use.
- Combination therapy with biologic DMARDs, TNF antagonists, other JAK inhibitors, or listed potent immunosuppressants is not authorized due to additive immunosuppression and infection risk.
Authorization duration and pediatric PsA age extension
Initial authorizations for chronic indications are issued for 12 months. Pediatric age extension for Psoriatic Arthritis has been applied per updated FDA labeling (Xeljanz pediatric age extension).
- Approval duration: 12 months for covered chronic indications.
- PsA pediatric age extension applied for Xeljanz per updated FDA labeling — check age-specific formulation rules (Xeljanz vs Xeljanz XR).
Required step therapy trials — document trials and failures
Prior to approval for most indications the provider must document trials and inadequate response or intolerance to specified conventional therapies and, where required, a trial of at least one TNF blocker—each trial duration and agent is defined per indication.
- Examples: MTX ≥ 3 consecutive months at maximally indicated doses for RA/pcJIA unless intolerant/contraindicated; for AS failure of ≥2 NSAIDs >4 weeks each; UC failure of an 8‑week systemic corticosteroid trial unless contraindicated.
- Many adult indications require failure or intolerance to ≥1 TNF blocker unless contraindicated.
Therapeutic alternatives — DMARDs and TNF blockers listed in appendices
Therapeutic alternatives (preferred prior therapies) such as conventional DMARDs and listed TNF blockers are provided in Appendix B and Appendix D; providers should document failure or intolerance to these alternatives when required.
- Appendix B lists preferred alternative therapies; Appendix D lists examples of TNF blockers (etanercept, adalimumab and biosimilars, infliximab and biosimilars, certolizumab, golimumab).
- Failure of methotrexate or other DMARDs is defined in Appendix D.
Therapy sequencing — allow bypass when prior biologic failure documented
If the member has previously failed a biologic agent, the policy permits bypassing conventional therapy step requirements; document prior biologic failure to support not stepping back to conventional DMARDs.
- Place in therapy updated after TNFi per FDA labeling; if member failed a biologic agent, document that failure to allow bypass of conventional therapy trials.
Required clinical documentation — office notes, labs, prior therapy details
Submit clinical documentation such as office chart notes, lab results, and other clinical information that support the diagnosis and show the member meets the specific approval criteria for the requested indication.
- Include documentation of prior therapy trials (dates, doses, outcomes) and any contraindications or intolerances.
- For UC and other indications, include disease activity measures when required (see UC score requirements).
Follow formulary/no‑coverage policy for recent label changes
If the drug had a label change within the prior 6 months that is not reflected in this policy, follow the applicable formulary/no‑coverage (CP.PMN.255) or non‑formulary (CP.PMN.16) policy, or the off‑label policy (CP.PMN.53) for uses not listed.
- Check whether the requested use falls under recent labeling changes; if so, route per the formulary or non‑formulary policy guidance referenced.
UC disease activity documentation — Mayo and modified Mayo score thresholds
For Ulcerative Colitis initial requests, provide objective disease‑activity documentation: a Mayo Score ≥ 6, modified Mayo Score ≥ 5, or a Mayo Endoscopic Score > 2 to document moderate‑to‑severe UC.
- Refer to Appendix E for supplemental information on calculating the modified Mayo Score when used for documentation.
Denial risk — insufficient supporting documentation
Failure to submit required supporting documentation (office chart notes, labs, prior therapy evidence, disease activity scores) may result in denial of the request.
- Ensure all required fields of the initial criteria are supported by contemporaneous clinical documentation to avoid denial.
Non‑FDA indications — off‑label requests require CP.PMN.53 documentation
Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless the provider supplies sufficient documentation per the off‑label use policy CP.PMN.53 or evidence of coverage documents.
- If the requested use is not listed and criterion for recent label change does not apply, follow CP.PMN.53 for supporting evidence submission.
Adalimumab examples removed — do not rely on historical product examples
Examples of preferred adalimumab products were removed from the policy (due to guideline recommendations); documenting preferred adalimumab examples may not support approval for UC—rely on the stated requirement of prior TNF blocker failure rather than historical example lists.
- The policy removed adalimumab examples based on 2024 AGA guideline findings; do not rely on historical adalimumab examples as proof of prior therapy adequacy for UC.
Scoring, Counts, and Clinical Thresholds
Terms and Product Formulations
Quantity and Formulation Limits
Drug Background and Scope
Tofacitinib (Xeljanz/Xeljanz XR) is an oral Janus kinase (JAK) inhibitor approved for several inflammatory conditions. FDA‑labeled adult indications include moderately to severely active rheumatoid arthritis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and active ankylosing spondylitis (each typically after inadequate response or intolerance to one or more TNF blockers). Xeljanz is also approved in pediatric patients ≥2 years for polyarticular‑course juvenile idiopathic arthritis and for pediatric PsA per updated labeling. The labeling also states that combining Xeljanz/Xeljanz XR with biologic DMARDs or potent immunosuppressants (for example, azathioprine or cyclosporine) is not recommended.
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