ModifiedUnitedHealthcarePolicy 2025 P 2207-14

Pa Med Nec Xeljanz

UnitedHealthcare prior authorization and medical necessity criteria for Xeljanz (tofacitinib) products for adults and for Xeljanz Oral Solution in patients ≥2 years for indicated conditions (RA, PsA, AS, UC, pcJIA). Defines initial authorization and reauthorization criteria, combination therapy exclusions, prescriber specialty requirements, trial/failure requirements, and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyPa Med Nec Xeljanz

Policy CodePolicy 2025 P 2207-14

Change TypeRevised (includes 12/2025 updates)

Effective DateMar 1, 2026

Next Review Date

Key ActionSubmit documentation (diagnosis, drug name, date, duration of prior trials) or claims history to support prior therapy and current therapy status for initial and reauthorization.

SourceLink

POLICY UPDATE CHANGES

Effective date set to 3/1/2026; P&T approvals listed through 12/2025 and program number updated.

Added coverage criteria for ankylosing spondylitis and polyarticular juvenile idiopathic arthritis in prior updates and updated combination therapy language to 'targeted immunomodulator' examples.

Clarified that patients established on therapy via manufacturer supplied samples must meet initial authorization criteria as if new to therapy.

Updated PsA criteria (12/2025) to include Xeljanz Oral Solution indication for patients 2 years and older.

5Covered Indications (RA, PsA, UC, AS, pcJIA)

12 monthsReauthorization duration

Typical DMARD trial requirement

2 NSAIDs × ≥4 wksAS NSAID requirement

Coverage Summary

Scope: UnitedHealthcare prior authorization and medical necessity criteria for Xeljanz (tofacitinib) products (Xeljanz, Xeljanz XR, Xeljanz Oral Solution) for adults and Xeljanz Oral Solution in patients ≥2 years for indicated conditions. Covered indications include Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ulcerative Colitis (UC), Ankylosing Spondylitis (AS), and Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA).

Coverage stance: covered with criteria — coverage is allowed when the program's indication-specific initial authorization or reauthorization criteria are met, including documented prior trials, prescriber specialty requirements, and evidence of clinical response for reauthorization.

High-level rules: prior authorization is required and approvals depend on documentation of diagnosis, prior therapy trials or claim history, and prescriber specialty. There are prescriber specialty restrictions (e.g., rheumatologist, dermatologist, or gastroenterologist as specified by indication). The policy excludes combination use of Xeljanz products with systemic targeted immunomodulators or with potent immunosuppressants for the same indication; established users via manufacturer samples or XELSOURCE assistance must meet initial criteria as if new.

Key thresholds & summary metrics

Authorization duration12 months

Typical non-biologic DMARD trial3 months

Ankylosing spondylitis NSAID requirementTwo NSAIDs, each ≥4 weeks

Covered indications (count)5

Covered indications (list)Rheumatoid arthritis; Psoriatic arthritis; Ulcerative colitis; Ankylosing spondylitis; Polyarticular-course juvenile idiopathic arthritis

Initial Therapy Criteria

Rheumatoid Arthritis (RA) - Initial Authorization

Xeljanz or Xeljanz XR will be approved based on all of the following criteria:

ALL of the following

Diagnosis of moderately to severely active RA
ONE of
- Option A
  - History of failure to a 3 month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses, unless contraindicated or clinically significant adverse effects experienced3 months
    Document drug, date, and duration of trial

Continuation / Reauthorization Criteria

Rheumatoid Arthritis (RA) - Reauthorization

Xeljanz or Xeljanz XR will be approved for reauthorization based on all of the following:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz XR therapy
ALL of the following
- Patient is not receiving Xeljanz or Xeljanz XR in combination with a systemic targeted immunomodulator for the same indication
- Patient is not receiving Xeljanz or Xeljanz XR in combination with a potent immunosuppressant (e.g., azathioprine or cyclosporine)

Psoriatic Arthritis (PsA) - Reauthorization

Combination Therapy Exclusions

The policy prohibits concurrent use of Xeljanz products with a systemic targeted immunomodulator for the treatment of the same indication. Examples of systemic targeted immunomodulators cited include adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi) and indication-specific biologic examples listed in the criteria.

The policy also prohibits concurrent use of Xeljanz products with potent immunosuppressants for the same indication. Examples of potent immunosuppressants explicitly listed as excluded combinations include azathioprine and cyclosporine, with additional examples for some indications including mycophenolate mofetil and 6-mercaptopurine.

These combination exclusions apply to initial authorization and reauthorization across indications (RA, PsA, UC, AS, pcJIA) and are enforced by requiring documentation that the patient is not receiving Xeljanz (or Xeljanz XR/Oral Solution) in combination with either a systemic targeted immunomodulator or a potent immunosuppressant for the same indication.

Applicable Codes

Drug (tofacitinib products)NDCCovered

No codes listed

Examples of systemic targeted immunomodulators referenced (informational)mixed

adalimumab	Example TNF inhibitor / targeted immunomodulator referenced
certolizumab (Cimzia)	Example referenced
etanercept (Enbrel)	Example referenced
baricitinib (Olumiant)	Example referenced
abatacept (Orencia)	Example referenced
upadacitinib (Rinvoq)	Example referenced
golimumab (Simponi)	Example referenced
bimekizumab (Bimzelx)	Example referenced
secukinumab (Cosentyx)	Example referenced
apremilast (Otezla)	Example referenced

1–10 of 16

1/2

Potent immunosuppressants referenced (excluded combinations)mixedNot Covered

azathioprine	Example potent immunosuppressant
cyclosporine	Example potent immunosuppressant
mycophenolate mofetil	Example referenced (UC, AS, pcJIA)
6-mercaptopurine	Example immunosuppressant referenced for UC

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Initial and reauthorization require submission of documentation (diagnosis, drug name, date, duration of prior trials) or claims history to support prior therapy and current therapy status; automated approvals may be permitted based on claims/diagnosis history.

Documentation Required

Document prior therapy trials

Document specific drugs, dates, and duration of trials for non-biologic DMARDs, TNF inhibitors, NSAIDs, corticosteroids or immunosuppressants as applicable to the indication; for current users, provide claims history or medical records to document drug, date, and duration of prior therapy.

Clinical Evidence & Background

Background: Tofacitinib (Xeljanz products) is a Janus kinase (JAK) inhibitor approved for multiple inflammatory conditions in adults and, for Xeljanz Oral Solution, in pediatric patients ≥2 years for approved indications including pcJIA and PsA.

The policy notes that use of Xeljanz/Xeljanz XR/Xeljanz Oral Solution in combination with biologic DMARDs or with potent immunosuppressants (for example, azathioprine and cyclosporine) is not recommended.

Primary reference: Xeljanz package insert (October 2025) is cited as the primary reference supporting the background, indications, and limitations of use.

Evidence / References

P&T Approval Dates5/2020, 11/2020, 6/2021, 12/2021, 2/2022, 5/2022, 6/2022, 9/2022, 7/2023, 9/2023, 10/2024, 10/2025, 12/2025

Primary ReferenceXeljanz package insert (October 2025)

Definitions

Current user: Patient with documented claims history or medical records showing active therapy with a Xeljanz product; receipt of manufacturer samples or XELSOURCE assistance alone does not qualify as proof of current user status.

Needle-phobia: A documented specific phobia (DSM‑V‑TR 300.29) in which the patient has previously refused injectable therapy or a medical procedure; this documentation may be used to support exemption from injectable therapy requirements.

Revision History

2026-03-01effective_date_changeLatest

Effective date set to 3/1/2026; P&T approvals listed through 12/2025 and program number updated.

12/2025revised

Updated PsA criteria to include Xeljanz Oral Solution indication for patients 2 years and older; background and references updated.

10/2025annual_review

Annual review with updated package insert reference and combination therapy examples/language updated with no change to clinical intent.

Policy Summary

PayerUnitedHealthcare

PolicyPa Med Nec Xeljanz

Policy CodePolicy 2025 P 2207-14

Change TypeRevised (includes 12/2025 updates)

Effective DateMar 1, 2026

Next Review Date

Key ActionSubmit documentation (diagnosis, drug name, date, duration of prior trials) or claims history to support prior therapy and current therapy status for initial and reauthorization.

SourceLink

On This Page

History of failure, contraindication, or intolerance to at least one TNF inhibitor

Patient previously treated with a systemic targeted immunomodulator FDA‑approved for RA as documented by claims history or medical records (document drug, date, duration). Examples: adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab

Counts as bypass of injectable requirement

Patient has documented needle‑phobia resulting in refusal of injectable therapy or medical procedure (refer DSM‑V‑TR 300.29)

Current user exception

Patient is currently on Xeljanz or Xeljanz XR therapy as documented by claims history or medical records
Document drug, date, and duration of therapy
Patient has not received a manufacturer supplied sample at no cost in the prescriber's office or any form of assistance from the Pfizer sponsored XELSOURCE program to establish current user
If prior samples/XELSOURCE used, initial criteria must be met as if new to therapy

ALL of the following

Patient is not receiving Xeljanz or Xeljanz XR in combination with a systemic targeted immunomodulator for the same indication (examples: adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab)
Patient is not receiving Xeljanz or Xeljanz XR in combination with a potent immunosuppressant (e.g., azathioprine or cyclosporine)

Prescribed by or in consultation with a rheumatologist

Psoriatic Arthritis (PsA) - Initial Authorization

Xeljanz, Xeljanz XR, or Xeljanz Oral Solution will be approved based on all of the following criteria:

ALL of the following

Diagnosis of active PsA
ONE of
- Option A
  - History of failure to a 3 month trial of methotrexate at maximally indicated dose, unless contraindicated or significant adverse effects experienced3 months
    Document date and duration of trial
  - History of failure, contraindication, or intolerance to at least one TNF inhibitor
- Patient previously treated with a systemic targeted immunomodulator FDA‑approved for PsA as documented by claims or medical records (document drug, date, duration). Examples: adalimumab, bimekizumab, certolizumab, secukinumab, etanercept, abatacept, apremilast, upadacitinib, golimumab, risankizumab, ixekizumab, guselkumab, ustekinumab
- Patient has documented needle‑phobia resulting in refusal of injectable therapy
  Refer DSM‑V‑TR 300.29
Current user exception
- Patient is currently on Xeljanz, Xeljanz XR, or Xeljanz Oral Solution therapy documented by claims or records
  Document drug, date, and duration of therapy
- Patient has not used manufacturer supplied sample or XELSOURCE assistance to establish current user
  If prior samples/XELSOURCE used, initial criteria must be met as if new to therapy
ALL of the following
- Patient is not receiving Xeljanz/XR/Oral Solution in combination with a systemic targeted immunomodulator for the same indication (examples listed above)
- Patient is not receiving Xeljanz/XR/Oral Solution in combination with a potent immunosuppressant (e.g., azathioprine or cyclosporine)
Prescribed by or in consultation with a rheumatologist or dermatologist

Ulcerative Colitis (UC) - Initial Authorization

Xeljanz or Xeljanz XR will be approved based on all of the following criteria:

ALL of the following

Diagnosis of moderately to severely active UC
ONE of
- Option A
  - Prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine)
  - History of failure, contraindication, or intolerance to at least one TNF inhibitor
- Patient previously treated with a systemic targeted immunomodulator FDA‑approved for UC as documented by claims or medical records (document drug, date, duration). Examples: adalimumab, vedolizumab, mirikizumab, upadacitinib, golimumab, risankizumab, guselkumab, ustekinumab, ozanimod
- Patient has documented needle‑phobia resulting in refusal of injectable therapy or medical procedure
  Refer DSM‑V‑TR 300.29
Current user exception
- Patient is currently on Xeljanz or Xeljanz XR therapy documented by claims or records
  Document drug, date, and duration of therapy
- Patient has not used manufacturer supplied sample or XELSOURCE assistance to establish current user
  If prior samples/XELSOURCE used, initial criteria must be met as if new to therapy
ALL of the following
- Patient is not receiving Xeljanz/XR in combination with a systemic targeted immunomodulator for the same indication (examples listed above)
- Patient is not receiving Xeljanz/XR in combination with a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
Prescribed by or in consultation with a gastroenterologist

Ankylosing Spondylitis (AS) - Initial Authorization

Xeljanz or Xeljanz XR will be approved based on all of the following criteria:

ALL of the following

Diagnosis of active ankylosing spondylitis
ONE of
- Option A
  - History of failure to two NSAIDs (e.g., ibuprofen, naproxen) at maximally indicated doses, each used for at least 4 weeks, unless contraindicated or significant adverse effects experiencedTwo NSAIDs × ≥4 weeks
    Document drug, date, and duration of trial
  - History of failure, contraindication, or intolerance to at least one TNF inhibitor
- Patient previously treated with a systemic targeted immunomodulator FDA‑approved for ankylosing spondylitis as documented by claims or records (document drug, date, duration). Examples: adalimumab, bimekizumab, certolizumab, secukinumab, etanercept, baricitinib, abatacept, golimumab, upadacitinib, ixekizumab
- Patient has documented needle‑phobia resulting in refusal of injectable therapy
  Refer DSM‑V‑TR 300.29
Current user exception
- Patient is currently on Xeljanz or Xeljanz XR therapy documented by claims or records
  Document drug, date, and duration of therapy
- Patient has not used manufacturer supplied sample or XELSOURCE assistance to establish current user
  If prior samples/XELSOURCE used, initial criteria must be met as if new to therapy
ALL of the following
- Patient is not receiving Xeljanz/XR in combination with a systemic targeted immunomodulator for the same indication
- Patient is not receiving Xeljanz/XR in combination with a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
Prescribed by or in consultation with a rheumatologist

Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) - Initial Authorization

Xeljanz or Xeljanz Oral Solution will be approved based on all of the following criteria:

ALL of the following

Diagnosis of active polyarticular-course juvenile idiopathic arthritis
ONE of
- History of failure, contraindication, or intolerance to at least one TNF inhibitor
- Patient has documented needle‑phobia resulting in refusal of injectable therapy or medical procedure
  Refer DSM‑V‑TR 300.29
- Current user exception
  - Patient is currently on Xeljanz or Xeljanz Oral Solution therapy documented by claims or records
    Document drug, date, and duration of therapy
  - Patient has not used manufacturer supplied sample or XELSOURCE assistance to establish current user
    If prior samples/XELSOURCE used, initial criteria must be met as if new to therapy
ALL of the following
- Patient is not receiving Xeljanz/Xeljanz Oral Solution in combination with a systemic targeted immunomodulator for the same indication (examples: adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab)
- Patient is not receiving Xeljanz/Xeljanz Oral Solution in combination with a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
Prescribed by or in consultation with a rheumatologist
Xeljanz Oral Solution is applicable for patients aged ≥2 years for applicable indications≥2 years for Oral Solution
Include age applicability

Reauthorization will be approved based on all of the following:

ALL of the following

Documentation of positive clinical response to therapy
ALL of the following
- Patient is not receiving Xeljanz/XR/Oral Solution in combination with a systemic targeted immunomodulator for the same indication
- Patient is not receiving Xeljanz/XR/Oral Solution in combination with a potent immunosuppressant (e.g., azathioprine or cyclosporine)

Ulcerative Colitis (UC) - Reauthorization

Reauthorization will be approved based on all of the following:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz XR therapy
ALL of the following
- Patient is not receiving Xeljanz/XR in combination with a systemic targeted immunomodulator for the same indication
- Patient is not receiving Xeljanz/XR in combination with a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

Ankylosing Spondylitis (AS) - Reauthorization

Reauthorization will be approved based on all of the following:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz XR therapy
ALL of the following
- Patient is not receiving Xeljanz/XR in combination with a systemic targeted immunomodulator for the same indication
- Patient is not receiving Xeljanz/XR in combination with a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) - Reauthorization

Reauthorization will be approved based on all of the following:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz Oral Solution therapy
ALL of the following
- Patient is not receiving Xeljanz/Xeljanz Oral Solution in combination with a systemic targeted immunomodulator for the same indication
- Patient is not receiving Xeljanz/Xeljanz Oral Solution in combination with a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

Denial Risk

Combination therapy exclusion

Claims or authorizations may be denied if the patient is receiving a Xeljanz product in combination with a systemic targeted immunomodulator or with a potent immunosuppressant for the same indication; combination therapy for the same indication is an exclusion.

Documentation Required

Needle‑phobia exception documentation

If using documented needle‑phobia to bypass injectable therapy requirements, provide documentation consistent with DSM‑V‑TR 300.29 showing prior refusal of injectable therapy or a medical procedure.

Billing Rule

Current user sample/XELSOURCE exclusion

Patients established on therapy solely via manufacturer-supplied samples or Pfizer XELSOURCE assistance must meet initial authorization criteria as if new to therapy; samples/XELSOURCE alone do not qualify as current user status.

7/2023revised

Updated 'not receiving in combination' language to 'targeted immunomodulator' and updated examples.

9/2022revised

Added criteria for continuation of care for polyarticular-course juvenile idiopathic arthritis and updated references.

2/2022revised

Added step through a TNF inhibitor for RA and pcJIA per updated label; added coverage criteria for ankylosing spondylitis and updated background and references.

6/2021revised

Removed preceding month requirement from failure criteria; removed prescriber requirement from reauthorization; added coverage criteria for patients previously treated with a biologic DMARD; clarified medical record submission for current therapy; updated UC criteria to require trial of oral corticosteroids and/or immunosuppressants.

11/2020revised

Added Xeljanz Oral Solution to the program and added Tremfya as step therapy medication for psoriatic arthritis; updated background and criteria due to new pcJIA indication.

5/2020new_program

Program initiated (new prior authorization/medical necessity program for Xeljanz products).

clarified

Clarified that patients established on therapy via manufacturer supplied samples or XELSOURCE assistance must meet initial authorization criteria as if new to therapy.