CurrentUnitedHealthcarePolicy 2025 P 2207-14

Tofacitinib (Xeljanz/Xeljanz XR/Xeljanz Oral Solution) prior authorization

Prior authorization / medical necessity criteria for Xeljanz, Xeljanz XR, and Xeljanz Oral Solution (tofacitinib) across indications: rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC), ankylosing spondylitis (AS), and polyarticular juvenile idiopathic arthritis (pcJIA). Defines initial and reauthorization requirements, combination exclusions, prescriber specialties, and duration of authorization.

Policy Summary

PayerUnitedHealthcare

PolicyTofacitinib (Xeljanz/Xeljanz XR/Xeljanz Oral Solution) prior authorization

Policy CodePolicy 2025 P 2207-14

Change TypeCriteria update (PsA indication added for oral solution)

Effective DateMar 1, 2026

Next Review Date

Key ActionProvide documentation of diagnosis and prior therapy trials (drug, dates, durations, and claims or medical records) for initial and reauthorization requests.

SourceLink

POLICY UPDATE CHANGES

12/2025: Updated PsA criteria to include Xeljanz Oral Solution for new indication for 2 years of age and older; updated background and reference.

Effective date set to 3/1/2026 per header; P&T approvals listed through 12/2025.

5Indications covered

12 moAuthorization length

3 moDMARD trial (RA/PsA)

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2 x 4wNSAID trials (AS)

Coverage Summary

Scope: Prior authorization and medical necessity criteria for Xeljanz, Xeljanz XR, and Xeljanz Oral Solution (tofacitinib) across indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC), ankylosing spondylitis (AS), and polyarticular juvenile idiopathic arthritis (pcJIA). The policy defines initial and reauthorization requirements, step-therapy and prior trial thresholds, prescriber specialty requirements, combination therapy exclusions, and typical authorization duration.

Coverage stance: Covered with criteria when the indication-specific prior authorization requirements are met (see policy number and effective date below). Policy number: 2025 P 2207-14. Effective date: 2026-03-01.

Quick facts and thresholds

Indications covered5 (RA, PsA, UC, AS, pcJIA)

Typical authorization length (reauthorization)12 months

Required DMARD trial (RA / PsA methotrexate)3 months (one non-biologic DMARD for RA; 3-month methotrexate trial for PsA)

NSAID trial requirement (Ankylosing spondylitis)History of failure to two NSAIDs, each used ≥4 weeks at maximally indicated doses

Policy number / Effective dateProgram #2025 P 2207-14; Effective date 2026-03-01

Initial Authorization Criteria (by indication)

Rheumatoid Arthritis (Initial Authorization)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active rheumatoid arthritis
ONE of
- 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 (document drug, date, and duration of trial)3 months
  Document drug, date, and duration
- 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 (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi))

Reauthorization / Continuation Criteria (by indication)

Ulcerative Colitis (Reauthorization)

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz XR therapy
NONE of the following concurrently
- Systemic targeted immunomodulator for the same indication (examples listed above)
- Potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

Ankylosing Spondylitis (Initial Authorization)

Covered when ALL of the following are met:

Concurrent Therapy Exclusions & Clinical Restrictions

Concurrent therapy exclusion

NONE of the following concurrently

Systemic targeted immunomodulator for treatment of the same indication (examples listed above)
Document examples in medical record/claims
Potent immunosuppressant (examples: azathioprine, cyclosporine, mycophenolate mofetil, 6-mercaptopurine)

Other recurring exclusion and documentation notes: manufacturer-supplied samples or assistance from the Pfizer XELSOURCE program may not be used to establish current use to bypass initial authorization requirements; patients established on therapy via samples/XELSOURCE must meet initial authorization criteria as if new to therapy.

Clinical recommendation: use of Xeljanz formulations in combination with biologic DMARDs or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil) for the same indication is not permitted and may lead to claim denial.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Initial and reauthorization require documentation per indication (diagnosis, prior trials, dates, durations, and claims or medical records).

Documentation Required

Document prior therapies and trial durations

Document drug, date, and duration of trials for prior DMARDs, targeted immunomodulators, TNF inhibitors, corticosteroids, immunosuppressants, or NSAIDs as applicable to the indication.

Documentation Required

Prescriber specialty requirement

Initial authorization must be prescribed by or in consultation with specified specialists per indication (rheumatologist, dermatologist, gastroenterologist).

Applicable Codes & Example Drug Classes

Examples of systemically targeted immunomodulators (listed in policy)mixed

	adalimumab
	certolizumab (Cimzia)
	etanercept (Enbrel)
	baricitinib (Olumiant)
	abatacept (Orencia)
	upadacitinib (Rinvoq)
	golimumab (Simponi)
	bimekizumab (Bimzelx)
	secukinumab (Cosentyx)
	apremilast (Otezla)

1–10 of 17

1/2

Potent immunosuppressants (examples)mixed

	azathioprine
	cyclosporine
	mycophenolate mofetil
	6-mercaptopurine

NSAID examples referencedmixed

	ibuprofen
	naproxen

Background & Definitions

Background: Tofacitinib (Xeljanz/Xeljanz XR/Xeljanz Oral Solution) is a Janus kinase (JAK) inhibitor.

FDA indications (high level): Xeljanz/Xeljanz XR are indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis in patients with inadequate response or intolerance to one or more TNF blockers. Xeljanz Oral Solution is indicated for treatment of active polyarticular juvenile idiopathic arthritis and active psoriatic arthritis in patients 2 years of age and older with inadequate response or intolerance to one or more TNF blockers.

Recommendation/limitation: The use with biologic DMARDs or potent immunosuppressants (e.g., azathioprine, cyclosporine) is explicitly not recommended.

Term	Definition
Needle-phobia	Documented needle-phobia to the degree the patient has previously refused any injectable therapy or medical procedure (referenced DSM-V-TR 300.29).
XELSOURCE	Pfizer sponsored assistance program; receipt of samples or assistance may not be used to establish current therapy for bypassing step requirements.

Clinical Evidence & References

Evidence and references: P&T approval dates span multiple reviews from 5/2020 through 12/2025 (latest 12/2025).

Primary product reference: Xeljanz package insert, Pfizer Labs; October 2025.

Revision History

2025-12material_change

12/2025: Updated psoriatic arthritis criteria to include Xeljanz Oral Solution indication for patients 2 years of age and older; background and reference updated.

2026-03-01revised_effective_dateLatest

Effective date set to 2026-03-01 per document header; P&T approvals listed through 12/2025.

Policy Summary

PayerUnitedHealthcare

PolicyTofacitinib (Xeljanz/Xeljanz XR/Xeljanz Oral Solution) prior authorization

Policy CodePolicy 2025 P 2207-14

Change TypeCriteria update (PsA indication added for oral solution)

Effective DateMar 1, 2026

Next Review Date

Key ActionProvide documentation of diagnosis and prior therapy trials (drug, dates, durations, and claims or medical records) for initial and reauthorization requests.

SourceLink

On This Page

Document drug, date, duration

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

Documented needle-phobia to the degree that the patient has previously refused any injectable therapy or medical procedure (refer to DSM-V-TR 300.29)

ALL of the following

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 XELSOURCE program, as a means to establish current user of Xeljanz/Xeljanz XR

Prescribed by or in consultation with a rheumatologist

Rheumatoid Arthritis (Reauthorization)

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz XR therapy
NONE of the following concurrently
- Systemic targeted immunomodulator for the same indication (examples listed in initial criteria)
  Examples: adalimumab, Bimzelx (bimekizumab), certolizumab (Cimzia), secukinumab (Cosentyx), etanercept (Enbrel), abatacept (Orencia), apremilast (Otezla), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), ixekizumab (Taltz), guselkumab (Tremfya), ustekinumab)
- Potent immunosuppressant (e.g., azathioprine or cyclosporine)

Psoriatic Arthritis (Initial Authorization)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of active psoriatic arthritis
ONE of
- History of failure to a 3 month trial of methotrexate at maximally indicated dose, unless contraindicated or clinically significant adverse effects (document date and duration)3 months
  Document date and duration
- Patient previously treated with a systemic targeted immunomodulator FDA-approved for psoriatic arthritis as documented by claims or medical records (document drug, date, duration). Examples: adalimumab, bimekizumab (Bimzelx), certolizumab (Cimzia), secukinumab (Cosentyx), etanercept (Enbrel), abatacept (Orencia), apremilast (Otezla), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), ixekizumab (Taltz), guselkumab (Tremfya), ustekinumab)
  Document drug, date, duration
- History of failure, contraindication, or intolerance to at least one TNF inhibitor
- Documented needle-phobia leading to refusal of injectable therapy or procedure (DSM-V-TR 300.29)
Patient is currently on Xeljanz, Xeljanz XR, or Xeljanz Oral Solution as documented by claims or medical records (document drug, date, duration)
Current-user pathway requires no samples/XELSOURCE assistance
NONE of the following concurrently
- Systemic targeted immunomodulator for treatment of the same indication (examples listed above)
- Potent immunosuppressant (e.g., azathioprine or cyclosporine)
Prescriber requirement
- Prescribed by or in consultation with a rheumatologist
- Prescribed by or in consultation with a dermatologist

Psoriatic Arthritis (Reauthorization)

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Xeljanz, Xeljanz XR, or Xeljanz Oral Solution therapy
NONE of the following concurrently
- Systemic targeted immunomodulator for the same indication (examples listed in initial criteria)
- Potent immunosuppressant (e.g., azathioprine or cyclosporine)

Ulcerative Colitis (Initial Authorization)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
ONE of
- Prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine)
- Patient previously treated with a systemic targeted immunomodulator FDA-approved for the treatment of ulcerative colitis as documented by claims or medical records (document drug, date, duration). Examples: adalimumab, vedolizumab (Entyvio), mirikizumab (Omvoh), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), guselkumab (Tremfya), ustekinumab, ozanimod (Zeposia)
  Document drug, date, duration
- History of failure, contraindication, or intolerance to at least one TNF inhibitor
- Documented needle-phobia leading to refusal of injectable therapy or procedure (DSM-V-TR 300.29)
Patient is currently on Xeljanz or Xeljanz XR therapy as documented by claims or medical records (document drug, date, duration)
Current-user pathway requires no samples/XELSOURCE assistance
NONE of the following concurrently
- Systemic targeted immunomodulator for the same indication (examples listed above)
- Potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
Prescribed by or in consultation with a gastroenterologist

ALL of the following

Diagnosis of active ankylosing spondylitis
ONE of
- History of failure to two NSAIDs (e.g., ibuprofen, naproxen) at maximally indicated doses, each used for at least 4 weeks, unless contraindicated or clinically significant adverse effects are experienced (document drug, date, duration)Two NSAIDs x >=4 weeks
  Document drug, date, duration
- Patient previously treated with a systemic targeted immunomodulator FDA-approved for the treatment of ankylosing spondylitis as documented by claims or medical records (examples: adalimumab, bimekizumab (Bimzelx), certolizumab (Cimzia), secukinumab (Cosentyx), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), golimumab (Simponi), upadacitinib (Rinvoq), ixekizumab (Taltz))
  Document drug, date, duration
- History of failure, contraindication, or intolerance to at least one TNF inhibitor
- Documented needle-phobia leading to refusal of injectable therapy or procedure (DSM-V-TR 300.29)
Patient is currently on Xeljanz or Xeljanz XR therapy as documented by claims or medical records (document drug, date, duration)
Current-user pathway requires no samples/XELSOURCE assistance
NONE of the following concurrently
- Systemic targeted immunomodulator for same indication (examples listed above)
- Potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
Prescribed by or in consultation with a rheumatologist

Ankylosing Spondylitis (Reauthorization)

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz XR therapy
NONE of the following concurrently
- Systemic targeted immunomodulator for same indication (examples listed above)
- Potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

Polyarticular Juvenile Idiopathic Arthritis (pcJIA) (Initial Authorization)

Covered when ALL of the following are met:

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
- Documented needle-phobia leading to refusal of injectable therapy or procedure (DSM-V-TR 300.29)
- Patient is currently on Xeljanz or Xeljanz Oral Solution as documented by claims or medical records (document drug, date, duration)
  Current-user pathway requires no samples/XELSOURCE assistance
NONE of the following concurrently
- Systemic targeted immunomodulator for same indication (examples: adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi))
- Potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
Prescribed by or in consultation with a rheumatologist

Polyarticular Juvenile Idiopathic Arthritis (Reauthorization)

Reauthorization approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Xeljanz or Xeljanz Oral Solution therapy
NONE of the following concurrently
- Systemic targeted immunomodulator for same indication (examples listed above)
- Potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

Rheumatologist: RA, AS, pcJIA, PsA (option)
Dermatologist: PsA
Gastroenterologist: UC

Documentation Required

Sample / XELSOURCE assistance

Patients established on therapy via manufacturer samples or XELSOURCE assistance must meet initial authorization criteria as if new to therapy; documentation must show patient has not used samples/XELSOURCE to establish current use when relying on current-use pathway.

Denial Risk

Concurrent therapy exclusion

Claim may be denied if patient is receiving Xeljanz/Xeljanz XR/Xeljanz Oral Solution in combination with a systemic targeted immunomodulator or potent immunosuppressant for the same indication.

Billing Rule

Authorization duration

Authorizations for reauthorization are issued for 12 months (where specified).

Typical reauthorization length = 12 months

Step Therapy

Step requirements

Requirement to try specified agents (e.g., non-biologic DMARD, methotrexate, TNF inhibitor, NSAIDs) prior to approval as specified per indication; exceptions for contraindication/intolerance or documented needle-phobia.