Cigna Xeljanz Prior Auth Coverage Update

Coverage Criteria for Xeljanz (tofacitinib)

Ankylosing Spondylitis

Covered when ONE of the following is met:

Ankylosing Spondylitis - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is >= 18 years of age; AND (ii) patient meets ONE of the following: (a) patient has had a 3-month trial of at least one tumor necrosis factor inhibitor (TNFi); OR (b) patient has tried at least one TNFi but was unable to tolerate a 3-month trial; AND (iii) medication is prescribed by or in consultation with a rheumatologist. B) Patient is Currently Receiving Xeljanz/Xeljanz XR: Approve for 1 year if BOTH of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) patient meets at least one of the following: (a) when assessed by at least one objective measure (e.g., ASDAS, BASDAI, CRP, ESR, ASQoL, BASFI, BAS-G, BASMI, DFI, HAQS), patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced an improvement in at least one symptom (such as decreased pain or stiffness, or improvement in function or activities of daily living).

Examples of objective measures listed in policy (ASDAS, BASDAI, CRP, ESR, etc.).

Juvenile Idiopathic Arthritis

Covered when ONE of the following is met:

Juvenile Idiopathic Arthritis (JIA) - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is > 2 years of age; AND (ii) patient meets ONE of the following: (a) patient has had a 3-month trial of at least one TNFi; OR (b) patient has tried at least one TNFi but was unable to tolerate a 3-month trial; AND (iii) medication is prescribed by or in consultation with a rheumatologist. B) Patient is Currently Receiving Xeljanz: Approve for 1 year if BOTH of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) patient meets at least one of the following: (a) when assessed by at least one objective measure (e.g., MD global, PGA, PDA, cJADAS, JSpADA, serum markers, or reduced corticosteroid dose) patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced an improvement in at least one symptom (e.g., improved function, less joint pain, decreased duration of morning stiffness or fatigue).

Xeljanz oral solution only indicated for polyarticular JIA; XR formulation not for JIA.

Psoriatic Arthritis

Covered when ONE of the following is met:

Psoriatic Arthritis - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is >= 18 years of age; AND (ii) patient meets ONE of the following: (a) patient has had a 3-month trial of at least one TNFi; OR (b) patient has tried at least one TNFi but was unable to tolerate a 3-month trial; AND (iii) the medication will be used in combination with methotrexate or another conventional synthetic DMARD unless contraindicated; AND (iv) medication is prescribed by or in consultation with a rheumatologist or dermatologist. B) Patient is Currently Receiving Xeljanz/Xeljanz XR: Approve for 1 year if ALL of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) medication is used in combination with methotrexate or another conventional synthetic DMARD unless contraindicated; AND (iii) patient meets at least one of the following: (a) when assessed by at least one objective measure (e.g., DAPSA, CPDAI, PsA DAS, MDA, PsAID-12, LEI, SPARCC, Leeds Dactylitis Instrument, serum markers) patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced an improvement in at least one symptom (such as less joint pain, morning stiffness, fatigue, improved function, or decreased soft tissue swelling).

Examples of objective measures listed (DAPSA, CPDAI, PsA DAS, MDA, etc.).

Rheumatoid Arthritis

Covered when ONE of the following is met:

Rheumatoid Arthritis - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is >= 18 years of age; AND (ii) patient meets ONE of the following: (a) patient has had a 3-month trial of at least one TNFi; OR (b) patient has tried at least one TNFi but was unable to tolerate a 3-month trial; AND (iii) medication is prescribed by or in consultation with a rheumatologist. B) Patient is Currently Receiving Xeljanz/Xeljanz XR: Approve for 1 year if BOTH of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) patient meets at least one of the following: (a) patient experienced a beneficial clinical response when assessed by at least one objective measure (e.g., CDAI, DAS28-ESR or CRP, RAPID-3, SDAI); OR (b) patient experienced an improvement in at least one symptom (such as decreased joint pain, morning stiffness, fatigue, improved function, or decreased soft tissue swelling).

Conventional synthetic DMARDs do not count as TNFi trials; methotrexate background use is permitted.

Ulcerative Colitis

Covered when ONE of the following is met:

Ulcerative Colitis - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is >= 18 years of age; AND (ii) patient meets ONE of the following: (a) patient has had a 3-month trial of at least one TNFi; OR (b) patient has tried at least one TNFi but was unable to tolerate a 3-month trial; AND (iii) medication is prescribed by or in consultation with a gastroenterologist. B) Patient is Currently Receiving Xeljanz/Xeljanz XR: Approve for 1 year if BOTH of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) patient meets at least one of the following: (a) when assessed by at least one objective measure (e.g., fecal calprotectin, CRP, endoscopic assessment, or reduced corticosteroid dose) patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced an improvement in at least one symptom (such as decreased pain, fatigue, stool frequency, or decreased rectal bleeding).

Examples of objective measures include fecal markers, serum markers, endoscopy, or corticosteroid dose reduction.

Concurrent administration of Xeljanz/Xeljanz XR with another biologic or with another targeted synthetic oral small molecule drug is considered not medically necessary. The policy states that combination therapy is generally not recommended because of a potentially higher rate of adverse events and a lack of controlled clinical data demonstrating additive efficacy. Do not prescribe Xeljanz in combination with other biologics or targeted synthetic oral small molecules for inflammatory conditions unless otherwise supported by updated evidence and policy guidance.

Use of Xeljanz/Xeljanz XR for renal transplantation is listed as a condition not covered. The policy cites insufficient data and references a Phase IIb kidney transplant study in which tofacitinib was comparable to cyclosporine for prevention of acute rejection, but it also notes safety concerns — specifically the potential for Epstein‑Barr virus‑associated post‑transplant lymphoproliferative disorder observed in certain transplant patients. Because of these uncertainties, Xeljanz is not approved for renal transplant use under this policy.

Operationally, the policy treats concomitant use of Xeljanz with other biologics or with another targeted synthetic oral small molecule drug, and concomitant use with potent immunosuppressants (examples include azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil) as not medically necessary. The rationale provided is an increased risk of additive immunosuppression and adverse events and the absence of controlled data evaluating such combinations in the covered indications. The policy explicitly notes that this restriction does not apply to background methotrexate use in rheumatoid arthritis where Xeljanz has been evaluated with methotrexate or other conventional DMARD combinations.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization requirement

Prior Authorization is recommended for prescription benefit coverage of Xeljanz/Xeljanz XR. All approvals are provided for the duration noted in the clinical criteria (e.g., initial approvals for 6 months, continuation approvals for 1 year where specified). In cases where the approval is authorized in months, 1 month is equal to 30 days. Prior authorization criteria are reviewed and updated periodically; check the policy history for annual revisions and selected updates. Prescribers must follow the criteria in the policy and submit documentation supporting the requested indication, prior therapies, treatment response, and any reasons for intolerance when applicable.

Approvals provided for durations specified in the FDA‑approved indication sections (e.g., 6 months initial, 1 year continuation).
1 month = 30 days for authorization calculations.
Policy criteria and prior authorization requirements are periodically updated (see HISTORY).

Documentation Required

Prescriber specialty requirement

Definitions and Drug Formulations

Tofacitinib formulations — Xeljanz/Xeljanz XR

Formulations includedTofacitinib tablets, oral solution, and extended‑release (Xeljanz/Xeljanz XR).

XR (extended‑release) restrictionsXR formulation is NOT indicated for polyarticular juvenile idiopathic arthritis (PJIA); oral solution is the formulation indicated for PJIA.

Indication-specific notesTablets and XR are approved for adult indications (AS, PsA, RA, UC) per prescribing indications; oral solution indicated only for polyarticular JIA.

Abbreviation — nr-axSpA

Abbreviationnr-axSpA = Non-radiographic axial spondyloarthritis.

Context of useListed in the appendix among other abbreviations and related spondyloarthritis terms (AS, nr-axSpA).

Background on Tofacitinib

Tofacitinib (Xeljanz/Xeljanz XR) is an oral Janus kinase (JAK) inhibitor used to treat multiple inflammatory conditions. The policy identifies FDA‑approved indications including ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis, and highlights that Xeljanz is generally not recommended in combination with biologics or certain potent immunosuppressants because of safety concerns and limited supporting data.

OpenPayer

Inflammatory Conditions - Xeljanz/Xeljanz XR Prior Authorization Policy

Coverage Criteria for Xeljanz (tofacitinib)

Prior Authorization, Documentation, and Provider Requirements

Definitions and Drug Formulations

Background on Tofacitinib