CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tofacitinib (Xeljanz) coverage — rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and pcJIA

Coverage criteria for Xeljanz (tofacitinib) products for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTofacitinib (Xeljanz) coverage — rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and pcJIA

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date2018-09-00 or as written

Next Review Date

Key ActionObtain prior authorization with submission of the member's medical record documenting specialist involvement, active disease, and prior therapy failures or contraindications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsTypical authorization duration

2/dayXeljanz tablet limit

1/dayXeljanz XR limit

10 ml/dayXeljanz solution limit

Required

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Coverage Criteria for Tofacitinib (Xeljanz)

Initial therapy — Rheumatoid arthritis

Covered when ALL of the following are met for moderately to severely active rheumatoid arthritis (RA):

RA initial approval: Prescribed by or in consultation with a rheumatology specialist; documented moderately to severely active rheumatoid arthritis; member has undergone pretreatment tuberculosis (TB) screening prior to treatment; submission of the member's chart or medical record documenting medical necessity; and member has experienced an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses OR member has positive rheumatoid biomarkers (positive rheumatoid factor [RF] or anti-cyclic citrullinated peptide [anti-CCP]) or elevated inflammatory markers (CRP and/or ESR)authorization typically 12 months

Biomarker testing (RF, anti-CCP, CRP/ESR) referenced in policy

Initial therapy — Psoriatic arthritis

Covered when ALL of the following are met for active psoriatic arthritis (PsA):

PsA initial approval: Prescribed by or in consultation with a dermatologist or rheumatology specialist; documented active psoriatic arthritis in an adult (≥18 years); member has experienced an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; member has experienced an inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab where indicated; and tofacitinib will be used in combination with a nonbiologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine)authorization typically 12 months

Combination with a nonbiologic DMARD required per policy

Initial therapy — Ankylosing spondylitis

Covered when ALL of the following are met for active ankylosing spondylitis (AS):

AS initial approval: Prescribed by or in consultation with a rheumatology specialist; documented active ankylosing spondylitis in an adult (≥18 years); member has experienced an inadequate response or has a contraindication to TWO (2) NSAIDs; and member has experienced an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated dosesauthorization typically 12 months

Both NSAID failure and biologic trial failure referenced

Initial therapy — Ulcerative colitis

Covered when ALL of the following are met for moderately to severely active ulcerative colitis (UC):

UC initial approval: Prescribed by or in consultation with a gastroenterologist; documented moderate to severely active ulcerative colitis in an adult (≥18 years); member has had an inadequate response, intolerance, or contraindication to a trial of infliximab IV or adalimumab at maximum tolerated doses; and member has had an inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab where indicated; submission of the medical record documenting medical necessity is requiredauthorization typically 12 months

Multiple prior biologic therapy trials referenced

Initial therapy — Juvenile idiopathic arthritis

Covered when ALL of the following are met for active polyarticular juvenile idiopathic arthritis (pcJIA) in patients ≥2 years:

pcJIA initial approval: Prescribed by or in consultation with a rheumatology specialist; patient is 2 years of age or older; and patient has experienced an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated dosesauthorization typically 12 months

Age and prior biologic trial specified

Continuation / renewal criteria

Continuation/renewal criteria — all indications:

Clinical response: Authorization of 12 months may be granted when the member achieves or maintains a positive clinical response as evidenced by disease-specific measures from baseline (examples: for RA — ≥20% improvement in tender or swollen joint counts, pain, or disability; for PsA — decreased swollen/tender joints, improvement in dactylitis, enthesitis, or skin/nail disease; for AS — improved functional status, reduced total spinal pain, or decreased morning stiffness; for UC — improvements in stool frequency, urgency, rectal bleeding, CRP, endoscopic mucosal appearance, fecal calprotectin, or validated endoscopic scoring; for pcJIA — decreased number of joints with limitation and improved functional ability)disease-specific improvement from baseline

Multiple specific measures listed per indication

All indications not explicitly listed as FDA‑approved or compendial uses in this policy are considered experimental/investigational and are not a covered benefit.

Use of Xeljanz (tofacitinib) is not permitted concomitantly with an injectable biologic response modifier (for example, TNF inhibitors such as adalimumab, etanercept, infliximab, golimumab; or interleukin inhibitors such as secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab, mirikizumab) or with certain other oral non‑biologic agents (for example, apremilast, baricitinib, upadacitinib, etrasimod). Such concomitant use is excluded and may result in denial.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required (typically 12 months)

Prior authorization is required for tofacitinib and is typically granted for 12 months when the indication-specific criteria are satisfied, including prescription by or consultation with the appropriate specialist, documented active disease, TB screening, submission of supporting medical records, and required prior therapy failures or contraindications.

Authorization of 12 months may be granted when all indication criteria are met (see RA, PsA, AS, UC, pcJIA sections).
Specialist involvement is required (rheumatology for RA, AS, pcJIA; dermatology or rheumatology for PsA; gastroenterology for UC).
Pretreatment TB screening is required for all indications.
Submission of documentation and evidence of prior inadequate response/intolerance/contraindication to specified therapies is required.

Step Therapy

Step therapy — required prior agent trials

For RA, PsA, AS, UC, and pcJIA, approval requires that the member has had an inadequate response, intolerance, or contraindication to the specified prior therapies (e.g., at least a 3-month trial of adalimumab at maximum tolerated doses for many indications; additional prior biologics such as ustekinumab or infliximab or NSAID trials are required where noted).

Product Codes and Clinical Response Measures

Product namesmixed

XELJANZ	tofacitinib (brand name listed)
XELJANZ XR	tofacitinib extended-release tablets
XELJANZ SOLUTION	tofacitinib oral solution

Product names (alternate grouping)mixed

XELJANZ	tofacitinib (brand name listed)
XELJANZ XR	tofacitinib extended-release tablets
XELJANZ SOLUTION	tofacitinib oral solution

Clinical response measures — examples

RA — joint improvement≥20% improvement from baseline in tender joint count, swollen joint count, pain, or disability

PsA — joint/soft-tissue measuresImprovement from baseline in number of swollen or tender joints, dactylitis, enthesitis, or skin/nail involvement

AS — functional/pain measuresImprovement from baseline in functional status, total spinal pain, or inflammatory features such as morning stiffness

UC — GI and inflammatory measuresImprovement from baseline in stool frequency, urgency, rectal bleeding, CRP, endoscopic mucosal appearance, or fecal calprotectin

pcJIA — joint/function measuresImprovement from baseline in number of joints with limited movement and in functional ability or disease activity score

Background on Tofacitinib (Xeljanz)

Tofacitinib (Xeljanz) is an oral Janus kinase (JAK) inhibitor indicated in this policy for multiple immune‑mediated inflammatory diseases, including moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active ulcerative colitis, and polyarticular course juvenile idiopathic arthritis in patients ≥2 years. Prior to treatment, members must have a documented pretreatment tuberculosis (TB) screening, and medical record documentation supporting the applicable indication and prior treatment history is required for authorization.

Definitions and FDA-Approved Indications

FDA‑approved indications listed in policy

Rheumatoid arthritis (RA)Moderately to severely active rheumatoid arthritis

Psoriatic arthritis (PsA)Active psoriatic arthritis

Ankylosing spondylitis (AS)Active ankylosing spondylitis

Ulcerative colitis (UC)Moderately to severely active ulcerative colitis

Polyarticular juvenile idiopathic arthritis (pcJIA)Polyarticular course juvenile idiopathic arthritis in patients ≥2 years of age