ModifiedCignaPolicy N/A

Prior Authorization: Rinvoq (upadacitinib) and Rinvoq LQ for inflammatory conditions

This policy governs prior authorization requirements for Rinvoq (upadacitinib extended-release tablets) and Rinvoq LQ (oral solution) for multiple inflammatory indications under Cigna-administered health benefit plans. It affects prescribers and reviewers seeking coverage for these medications.

Policy Summary

PayerCigna

PolicyPrior Authorization: Rinvoq (upadacitinib) and Rinvoq LQ for inflammatory conditions

Policy CodePolicy N/A

Change TypeIndication additions and revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of specialist involvement and required prior TNF inhibitor trial (or intolerance) per indication.

SourceLink

POLICY UPDATE CHANGES

For initial approvals in non-radiographic axial spondyloarthritis a requirement that the patient is ≥ 18 years of age was added.

Juvenile Idiopathic Arthritis was added as a newly approved indication.

Conditions Not Covered: Concurrent use with a biologic or targeted synthetic oral small molecule drug wording was changed and concurrent use with another JAK inhibitor was removed.

Giant Cell Arteritis indication added and steroid requirement for that indication was revised to require trying or currently taking systemic corticosteroid unless contraindicated.

For most indications specified approval is for Rinvoq tablets, not Rinvoq LQ oral solution (except JIA and psoriatic arthritis where LQ is allowed).

9+FDA indications

3–6 moInitial approval

1 yrContinuation approval

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Coverage Criteria for Rinvoq (upadacitinib)

Ankylosing Spondylitis

Covered when one of the following is met

Ankylosing Spondylitis A or B: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 18 years of age; AND ii. Patient has had a 3-month trial of at least ONE tumor necrosis factor (TNF) inhibitor OR tried at least one TNF inhibitor but was unable to tolerate a 3-month trial (conventional synthetic DMARDs do not count); AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Rinvoq extended-release tablets: 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 patient experienced a beneficial clinical response from baseline; OR b) compared with baseline patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function).see text

Objective measure examples: ASDAS, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQS, serum markers (CRP, ESR) (see chunk 12)

Atopic Dermatitis

Covered when one of the following is met

Atopic Dermatitis A or B: A) Initial Therapy: Approve for 3 months if ALL of the following are met: i. Patient is ≥ 12 years of age; AND ii. Patient has had a 4-month trial of at least ONE systemic therapy OR tried at least one systemic therapy but was unable to tolerate a 4-month trial (examples include dupilumab, lebrikizumab, nemolizumab, tralokinumab, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil); AND iii. Medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist. OR B) Patient is Currently Receiving Rinvoq extended-release tablets: Approve for 1 year if ALL of the following are met: i. Patient has been established on therapy ≥ 90 days; AND ii. Beneficial clinical response defined by listed skin/body measures; AND iii. Improvement in at least one symptom (e.g., decreased itching).see text

Examples of systemic therapies and objective/clinical response measures are listed in chunk 12.

Crohn's Disease

Covered when one of the following is met

Crohn's Disease A or B: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 18 years of age; AND ii. Patient has had a 3-month trial of at least ONE TNF inhibitor OR tried at least one TNF inhibitor but was unable to tolerate a 3-month trial (see Appendix for examples; conventional synthetic DMARDs do not count); AND iii. Medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Rinvoq extended-release tablets: 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 patient experienced a beneficial clinical response from baseline (examples include fecal markers, CRP, imaging, endoscopic assessment, and/or reduced corticosteroid dose); OR b) compared with baseline patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, blood in stool).see text

Objective measure examples in chunk 14.

Giant Cell Arteritis

Covered when one of the following is met

Giant Cell Arteritis A or B: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is > 18 years of age; AND ii. Patient has tried or is currently taking a systemic corticosteroid (e.g., prednisone) OR systemic corticosteroids are contraindicated; AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Rinvoq extended-release tablets: 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 patient experienced a beneficial clinical response from baseline (examples include CRP, ESR, resolution of fever, reduced corticosteroid dose); OR b) compared with baseline patient experienced an improvement in at least one symptom (e.g., decreased headache, scalp or jaw pain, fatigue, improved vision).see text

Steroid requirement: must have tried or be currently taking systemic corticosteroid unless contraindicated (chunk 15).

Juvenile Idiopathic Arthritis (JIA)

Covered when one of the following is met

JIA A or B: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 2 years of age; AND ii. Patient has had a 3-month trial of at least ONE TNF inhibitor OR tried at least one TNF inhibitor but was unable to tolerate a 3-month trial (conventional synthetic DMARDs do not count); AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Rinvoq or Rinvoq LQ: 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 patient experienced a beneficial clinical response from baseline (examples include MD global, PGA, PDA, JADAS, cJADAS, JSpADA, CRP/ESR, or reduced corticosteroid dose); OR b) compared with baseline patient experienced an improvement in at least one symptom (e.g., less joint pain, decreased morning stiffness, improved function).see text

Rinvoq LQ oral solution is permitted for pediatric indications (JIA) per chunks 16–17; LQ is not substitutable with tablets (see chunk 4 in brief).

Non-Radiographic Axial Spondyloarthritis

Covered when one of the following is met

Non-Radiographic Axial SpA A or B: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 18 years of age; AND ii. Patient has objective signs of inflammation defined as at least ONE of: a) CRP elevated beyond ULN for the reporting laboratory; OR b) sacroiliitis reported on MRI; AND iii. Patient has had a 3-month trial of at least ONE TNF inhibitor OR tried at least one TNF inhibitor but was unable to tolerate a 3-month trial; AND iv. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Rinvoq extended-release tablets: 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 patient experienced a beneficial clinical response from baseline (examples including ASDAS, BASDAI, serum markers); OR b) compared with baseline patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function).see text

Material change: initial approvals require patient ≥18 years (chunk 16/18).

Psoriatic Arthritis

Covered when one of the following is met

Psoriatic Arthritis A or B: A) Initial Therapy: Approve for 6 months if ALL of the following are met: i. Patient is ≥ 2 years of age; AND ii. Patient has had a 3-month trial of at least ONE TNF inhibitor OR tried at least one TNF inhibitor but was unable to tolerate a 3-month trial (conventional synthetic DMARDs do not count); AND iii. Medication is prescribed by or in consultation with a rheumatologist or dermatologist. OR B) Patient is Currently Receiving Rinvoq or Rinvoq LQ: 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 patient experienced a beneficial clinical response from baseline (examples include DAPSA, CPDAI, PsA DAS, MDA, PsAID-12, CRP/ESR); OR b) compared with baseline patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, improved function).see text

Conventional synthetic DMARDs do not count toward the TNFi requirement (chunk 19). Rinvoq LQ permitted for pediatric PsA (chunk 19/20).

Initial and Continuation Therapy criteria (generalized)

Covered when indication-specific initial or continuation criteria are met.

Indication coverage groups: One of the following indication groups must apply (see indication-specific sections).

Each indication contains an Initial Therapy (A) branch and a Currently Receiving (B) branch with the logic below.

Initial Therapy (general)

Age: Patient meets the minimum age for the requested indication (e.g., ≥2 years for JIA/PsA pediatric indications, ≥12 years for atopic dermatitis, ≥18 years for many adult indications).
See indication-specific criteria.
Prior TNF inhibitor trial: Patient has had a 3-month trial of at least ONE TNF inhibitor OR tried at least one TNF inhibitor but was unable to tolerate a 3-month trial. Conventional synthetic DMARDs do NOT count toward the TNF inhibitor requirement.3 months

For all indications, Rinvoq and Rinvoq LQ are not recommended to be used in combination with other Janus kinase inhibitors (JAKis), biologic therapies, or other potent immunosuppressants (for example, azathioprine or cyclosporine). This guidance reflects concern for increased immunosuppression and potential safety risks when these agents are co‑administered.

Coding and Billing Guidance

Coding guidance notemixed

No codes listed

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior Authorization is recommended for prescription benefit coverage of Rinvoq/Rinvoq LQ. All approvals are provided for the duration noted in the policy; when expressed in months, 1 month = 30 days. Initial prescriptions must be written by or in consultation with a physician who specializes in the condition being treated (e.g., rheumatologist, gastroenterologist, dermatologist, or other appropriate specialist per indication).

Prior authorization is required for Rinvoq and Rinvoq LQ; approvals are granted for the duration specified in the FDA‑indication sections (e.g., 3 or 6 months for initial therapy, 1 year for continuation when criteria met).
Initial prescribing must be by or in consultation with a specialist appropriate to the indication.

Denial Risk

Coding / Coverage Mismatch Denial Risk

Claims submitted with diagnosis or procedure codes that do not match a covered indication in this policy may be denied as not covered. Providers must bill using the most appropriate and specific codes for the service and diagnosis as of the date of submission. Review the plan’s coding guidance and the policy’s covered diagnoses before submitting a claim.

Definitions and Measurement Criteria

Rinvoq LQ substitution note (inv-23)

Substitution statusRinvoq LQ oral solution is not substitutable with Rinvoq extended‑release tablets.

Indicated pediatric uses for Rinvoq LQRinvoq LQ oral solution is indicated only for polyarticular juvenile idiopathic arthritis (JIA) and psoriatic arthritis in patients 2 to <18 years of age.

Formulation coverage noteFor most indications, coverage and initial approvals specify Rinvoq extended‑release tablets; Rinvoq LQ is allowed only for the pediatric indications noted (JIA and PsA ages 2 to <18).

Concurrent therapy cautionRinvoq/Rinvoq LQ is not recommended for use in combination with other JAK inhibitors, biologics, or potent immunosuppressants (e.g., azathioprine, cyclosporine).

Objective measures of response (inv-24)

Examples of validated indices — spondyloarthritis