ModifiedMass General Brigham Health PlanPolicy N/A

Xeljanz_Xeljanz_XR_Prior_Authorization_Criteria

Prior authorization and quantity-limit policy for Xeljanz (tofacitinib) and Xeljanz XR for pharmacy benefit indications including RA, PsA, UC, pcJIA, and ankylosing spondylitis; defines initial and continuation criteria, required prior trials, approval durations, and quantity limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXeljanz_Xeljanz_XR_Prior_Authorization_Criteria

Policy CodePolicy N/A

Change TypeCriteria revised (indication-specific and reauthorization updates)

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required for Xeljanz/Xeljanz XR; submit documentation of trials/failures and clinical improvement to support approval and reauthorization.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for ulcerative colitis to remove disease characteristic requirement and allow approval if disease severity warrants systemic biologic as first-line therapy; initial approval length for UC updated to 24 months.

Specified approvable formulations for each indication and updated reauthorization criteria to require documentation of clinical response.

Updated criteria to be in line with FDA approved indication and removed TB requirement; added examples for each indication and updated conventional therapies.

5Indications covered

24 monthsStandard approval duration

90 daysNew-to-plan grace period

Coverage Summary

Xeljanz / Xeljanz XR (tofacitinib) is covered with criteria for the following indications: rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC), polyarticular-course juvenile idiopathic arthritis (pcJIA), and ankylosing spondylitis. Approval requires meeting the diagnosis-specific prior-trial and failure/intolerance/contraindication criteria listed below, and initial approvals are generally granted for 24 months. Members who are new to the plan within the past 90 days and are currently receiving the medication may be authorized without meeting all diagnosis-specific entry criteria (excluding product obtained via samples or manufacturer patient assistance programs).

Quick Facts / Thresholds

New-to-plan grace period90 days

Standard approval duration24 months

RA conventional therapy trial duration3-month trial and failure/intolerance/contraindication to ONE conventional therapy at maximally tolerated doses

pcJIA conventional therapy trial durationMinimum 6-week trial and failure/intolerance/contraindication to ONE conventional therapy at maximally tolerated doses

Ankylosing spondylitis trial durationMinimum 1-month trial and failure/contraindication/intolerance to TWO therapies

Initial Therapy Criteria (by indication)

General Authorization Conditions

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication OR when ALL of the following diagnosis-specific criteria are met:

ANY of the following

ALL of the following
- Member new to the plan within the past 90 days who is currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs)
Diagnosis-specific criteria (see indication-specific trees below) are met

ref”: “b1_0”

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy / Reauthorization

Requests for reauthorization will be approved when ALL of the following are met:

ALL of the following

Documentation is submitted supporting improvement in member's condition as evidenced by low disease activity or improvement in signs and symptoms of the condition

Documentation Required

Documentation for reauthorization

Submit documentation showing clinical improvement or low disease activity (improvement in signs and symptoms) to support reauthorization.

Unproven / Exclusions and Definitions

The policy does not list standalone 'not medically necessary' exclusions in the brief; instead it documents definitions, prior-review history, and notable exceptions. Per prior updates, the policy removed the tuberculosis (TB) screening requirement in 2023 and clarified indication and age requirements in subsequent reviews. Exceptions and contact information for prior authorization are provided in the policy header.

TNF inhibitors / TNF blockers: examples listed in the policy include adalimumab, certolizumab pegol, etanercept, and golimumab; for pcJIA the policy specifically cites adalimumab and etanercept as examples.

Applicable Codes and Quantity Limits

Quantity limits (formulation-specific)mixed

Xeljanz tablet	Quantity Limitation: 2 tablets per day
Xeljanz XR tablet	Quantity Limitation: 1 tablet per day
Xeljanz oral solution	Quantity Limitation: 240 mL per 30 days

Billing Rule

Approval duration

Approvals will be granted for 24 months. Initial approval length for ulcerative colitis has been updated to 24 months.

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Xeljanz/Xeljanz XR. Contact for specialty medications: Phone 877-519-1908, Fax 855-540-3693. Contact for non-specialty medications: Phone 800-711-4555, Fax 844-403-1029. Members new to the plan within the past 90 days who are currently receiving the requested medication may be granted authorization per the General Authorization Conditions.

Documentation Required

Trial and failure documentation

Document trials, failures, intolerances, or contraindications to the specified conventional therapies and to TNF inhibitors as required for the member's indication (for example: RA — 3-month trial of a conventional therapy such as methotrexate, leflunomide, or sulfasalazine; UC — trial/failure of one conventional therapy such as azathioprine, 6-mercaptopurine, aminosalicylates, or corticosteroids; pcJIA — minimum 6-week trial of methotrexate or leflunomide; AS — minimum 1-month trial and failure of two therapies).

Clinical Evidence and References

Evidence sources cited in the brief include the Xeljanz / Xeljanz XR prescribing information (Pfizer, February 2025) and guidelines such as the 2021 ACR guideline for rheumatoid arthritis and AGA/ACG and related ulcerative colitis guidelines (2019–2020 references cited).

Background

Background: Tofacitinib is a Janus kinase (JAK) inhibitor indicated for RA, PsA, UC, pcJIA, and ankylosing spondylitis. The policy requires documented prior trials of specified conventional therapies and, for most indications, prior inadequate response or intolerance to one or more TNF inhibitors before authorization. Indication-specific minimum trial durations and requirements are defined (for example, a 3-month conventional therapy trial for RA, a 6-week conventional therapy trial for pcJIA, and a 1-month trial requirement related to ankylosing spondylitis), and the policy allows exceptions for failure, intolerance, or contraindication. Continuation/reauthorization requires documentation of clinical improvement or low disease activity.

Revision History

2025-07-01revisionLatest

Removed prior disease characteristic requirement for ulcerative colitis and allowed approval if disease severity warrants systemic biologic as first-line therapy; initial approval length for UC updated to 24 months.

2025-01-01revision

Specified approvable formulations for each indication and updated reauthorization criteria to require documentation of clinical response.

2024-01-01revision

Criteria aligned with FDA-approved indication and TB requirement removed; examples added for each indication and conventional therapies updated.