Modifiedblue cross blue shield - louisianaPolicy 00692

upadacitinib (Rinvoq, Rinvoq LQ) coverage

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This policy governs medical coverage and authorization criteria for upadacitinib (Rinvoq, Rinvoq LQ) across Blue Cross and Blue Shield of Louisiana products; it applies to members when benefits and medical necessity criteria are met.

Policy Summary

PayerBlue Cross Blue Shield - Louisiana

Policyupadacitinib (Rinvoq, Rinvoq LQ) coverage

Policy CodePolicy 00692

Change TypeMaterial updates to prior‑therapy and DMARD denial rulesnew FDA indications added

Effective DateJul 1, 2026

Last ReviewApr 16, 2026

Next Review DateApr 1, 2027

Key ActionRequire documented trial and failure of Humira or Enbrel for rheumatoid arthritis prior to coverage consideration.

SourceLink

POLICY UPDATE CHANGES

A requirement for trial and failure of Humira or Enbrel in rheumatoid arthritis was added.

A new FDA-approved indication, psoriatic arthritis, was added along with subsequent patient selection criteria.

Traditional DMARD usage was switched to a 'not medically necessary' denial (i.e., DMARD rules were changed to trigger denials).

Clarified that other TNF failures can count in lieu of a trial and failure of Humira or Enbrel, where applicable.

Added criteria and updated policy for a new FDA‑approved indication: atopic dermatitis.

multipleindications covered

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Modifiedblue cross blue shield - louisianaPolicy 00692

upadacitinib (Rinvoq, Rinvoq LQ) coverage

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Sign up for blue cross blue shield - louisiana Policy 00692 alerts

Get alerted when Policy 00692 changes without checking for updates manually.

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Policy Summary

PayerBlue Cross Blue Shield - Louisiana

Policyupadacitinib (Rinvoq, Rinvoq LQ) coverage

Policy CodePolicy 00692

Change TypeMaterial updates to prior‑therapy and DMARD denial rulesnew FDA indications added

Effective DateJul 1, 2026

Last ReviewApr 16, 2026

Next Review DateApr 1, 2027

Key ActionRequire documented trial and failure of Humira or Enbrel for rheumatoid arthritis prior to coverage consideration.

SourceLink

POLICY UPDATE CHANGES

A requirement for trial and failure of Humira or Enbrel in rheumatoid arthritis was added.

A new FDA-approved indication, psoriatic arthritis, was added along with subsequent patient selection criteria.

Traditional DMARD usage was switched to a 'not medically necessary' denial (i.e., DMARD rules were changed to trigger denials).

Clarified that other TNF failures can count in lieu of a trial and failure of Humira or Enbrel, where applicable.

Added criteria and updated policy for a new FDA‑approved indication: atopic dermatitis.

multipleindications covered

requiredTB test prerequisite

not medically necessaryDMARD status

requiredHumira/Enbrel trial

Indication-specific Coverage Criteria

Indication-specific coverage criteria

The Company may consider upadacitinib to be eligible for coverage for the following indications when all patient selection criteria are met.

Rheumatoid Arthritis: Moderately to severely active rheumatoid arthritis; patient is ≥18 years of age; failed ≥1 traditional DMARD (e.g., methotrexate) unless contraindicated; drug not used in combination with biologic DMARDs (e.g., adalimumab, etanercept), potent immunosuppressants (e.g., azathioprine, cyclosporine), apremilast, or tofacitinib; failed etanercept OR adalimumab (or another TNF inhibitor) after ≥2 months of therapy (failure of another TNF inhibitor counts).

Psoriatic Arthritis: Diagnosis of active psoriatic arthritis; patient is ≥2 years of age; if Rinvoq LQ requested patient <18 years; if Rinvoq tablets requested patient ≥30 kg; failed ≥1 traditional DMARD (e.g., methotrexate) unless contraindicated; drug not used in combination with biologic DMARDs or potent immunosuppressants or specified agents; failed etanercept OR adalimumab (or another TNF inhibitor) after ≥2 months of therapy; negative TB test prior to treatment.

Atopic Dermatitis: Moderate to severe atopic dermatitis; patient is ≥12 years of age; chronic disease ≥6 months; BSA involvement ≥10%; tried and failed ≥1 prescription topical corticosteroid or calcineurin inhibitor unless contraindicated; tried and failed ≥1 systemic therapy for ≥3 months (methotrexate, azathioprine, cyclosporine, mycophenolate mofetil) or intolerant — failure of dupilumab or tralokinumab counts; drug not used in combination with other JAK inhibitors, monoclonal antibodies, or systemic immunosuppressants; negative TB test prior to treatment.

Ulcerative Colitis: Diagnosis of moderately to severely active ulcerative colitis; patient is ≥18 years of age; failed a TNF inhibitor after ≥2 months unless clinically inadvisable OR failed at least one conventional therapy (corticosteroid, azathioprine, 6‑MP) if TNF inhibitor clinically inadvisable; drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib; negative TB test prior to treatment.

Crohn's Disease: Diagnosis of moderately to severely active Crohn's disease; patient is ≥18 years of age; failed a TNF inhibitor after ≥2 months unless clinically inadvisable OR failed at least one conventional therapy (corticosteroid, azathioprine, 6‑MP) if TNF inhibitor clinically inadvisable; drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib; negative TB test prior to treatment.

Ankylosing Spondylitis: Diagnosis of active ankylosing spondylitis; patient is ≥18 years of age; failed NSAIDs unless clinically inadvisable; failed etanercept OR adalimumab (or another TNF inhibitor) after ≥2 months unless clinically inadvisable; drug not used in combination with other biologic DMARDs or potent immunosuppressants or specified agents; negative TB test prior to treatment.

Non‑radiographic Axial Spondyloarthritis: Active non‑radiographic axial spondyloarthritis confirmed by sacroiliitis on MRI; failed ≥2 months continuous therapy with ≥2 different oral NSAIDs at prescription strength unless clinically inadvisable; failed certolizumab pegol after ≥2 months unless clinically inadvisable; patient is ≥18 years of age; drug not used in combination with other biologic DMARDs or potent immunosuppressants or specified agents; negative TB test prior to treatment.

Polyarticular Juvenile Idiopathic Arthritis (pJIA): Diagnosis of polyarticular JIA; patient is ≥2 years of age; if Rinvoq LQ requested patient <18 years; if Rinvoq tablets requested patient ≥30 kg; failed ≥1 traditional DMARD (e.g., methotrexate) unless contraindicated; failed etanercept OR adalimumab (or another TNF inhibitor) after ≥2 months unless clinically inadvisable; drug not used in combination with other biologic DMARDs or potent immunosuppressants; negative TB test prior to treatment.

Giant Cell Arteritis (GCA): Diagnosis of giant cell arteritis; patient is ≥18 years of age; used in combination with a tapering course of corticosteroids; failed systemic corticosteroid therapy unless contraindicated; drug not used in combination with other biologic DMARDs or potent immunosuppressants; negative TB test prior to treatment.

Ulcerative Colitis criteria

Ulcerative colitis coverage will be considered when all criteria below are met.

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
Patient is ≥18 years of age
ONE of
- Failed treatment with a TNF inhibitor (e.g., adalimumab) after ≥2 months unless clinically inadvisable
- Failed treatment with at least one conventional therapy (corticosteroid, azathioprine, 6‑MP) if TNF inhibitor clinically inadvisable
Requested drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib

Ankylosing Spondylitis criteria

Ankylosing spondylitis coverage will be considered when all criteria below are met.

ALL of the following

Diagnosis of active ankylosing spondylitis
Patient is ≥18 years of age
Failed treatment with NSAIDs unless clinically inadvisable
Failed etanercept OR adalimumab (or another TNF inhibitor) after ≥2 months unless clinically inadvisable
Requested drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib

Non-radiographic Axial Spondyloarthritis criteria

Non-radiographic axial spondyloarthritis coverage will be considered when all criteria below are met.

ALL of the following

Active non‑radiographic axial spondyloarthritis confirmed by sacroiliitis on MRI
Failed ≥2 months continuous therapy with ≥2 different oral NSAIDs at prescription strength unless clinically inadvisable
Failed certolizumab pegol (Cimzia) after ≥2 months unless clinically inadvisable
Patient is ≥18 years of age
Requested drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib

Crohn's Disease criteria

Crohn's disease coverage will be considered when all criteria below are met.

ALL of the following

Diagnosis of moderately to severely active Crohn's disease
Patient is ≥18 years of age
ONE of
- Failed treatment with a TNF inhibitor (e.g., adalimumab) after ≥2 months unless clinically inadvisable
- Failed treatment with at least one conventional therapy (corticosteroid, azathioprine, 6‑MP) if TNF inhibitor clinically inadvisable
Requested drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib

Polyarticular Juvenile Idiopathic Arthritis criteria

Polyarticular juvenile idiopathic arthritis coverage will be considered when all criteria below are met.

ALL of the following

Diagnosis of polyarticular juvenile idiopathic arthritis
Patient is ≥2 years of age
If Rinvoq LQ requested, patient <18 years of age
If Rinvoq tablets requested, patient ≥30 kg
Failed ≥1 traditional DMARD (e.g., methotrexate) unless contraindicated
Failed etanercept OR adalimumab (or another TNF inhibitor) after ≥2 months unless clinically inadvisable

JIA criteria set

Polyarticular juvenile idiopathic arthritis — initial and continuation coverage criteria

ALL of the following

Initial: Diagnosis of polyarticular JIA; age ≥2 years; if Rinvoq LQ requested patient <18 years; if Rinvoq tablets requested patient ≥30 kg; failed ≥1 traditional DMARD unless contraindicated; failed etanercept OR adalimumab (or another TNF inhibitor) after ≥2 months; negative TB test prior to treatment; drug not used in combination with disallowed agents.

ALL of the following

Continuation: Prior authorization granted; documented beneficial clinical response from baseline (e.g., improved range of motion, reduced pain, decreased morning stiffness, reduced corticosteroid dose, improvement in inflammatory serum markers); drug not used in combination with disallowed agents.

GCA criteria set

Giant cell arteritis — coverage consideration and criteria

ALL of the following

Initial: Diagnosis of giant cell arteritis; patient is ≥18 years of age; used in combination with a tapering course of corticosteroids; failed systemic corticosteroid therapy unless contraindicated; requested drug not used in combination with other biologic DMARDs or potent immunosuppressants; patient has a negative TB test prior to treatment.

ALL of the following

Continuation: Prior authorization granted; documented beneficial clinical response from baseline (e.g., decreased headache, improved vision, reduced steroid dose, improvement in inflammatory markers); drug not used in combination with disallowed agents.

Initial use must be with a tapering course of corticosteroids and a negative TB test is required prior to treatment.

Other indications and investigational/Not medically necessary rules

Other indications — examples of required failures and continuation expectations; uses considered not medically necessary or investigational when criteria unmet.

Uses not meeting specified criteria are considered not medically necessary; certain formulations/doses/indications are investigational as listed.

Coverage history notes

Policy history entries describe prior committee reviews and note past additions to coverage eligibility such as requirements for trial and failure of specific TNF inhibitors for rheumatoid arthritis and additions of FDA‑approved indications (e.g., psoriatic arthritis).

Policy history documents Medical Policy Committee and Implementation Committee reviews and records additions such as the requirement for trial and failure of Humira (adalimumab) or Enbrel (etanercept) in rheumatoid arthritis and addition of psoriatic arthritis as an FDA‑approved indication.

Policy history cites the Rinvoq package insert (AbbVie) updated October 2025 for clinical and label information.

Recorded coverage-related changes (policy history)

Policy history entries indicating modifications to coverage criteria:

Requirement: Trial and failure of Humira (adalimumab) or Enbrel (etanercept) required for rheumatoid arthritis coverage (policy history entries).

Addition: Psoriatic arthritis added as an FDA‑approved indication with subsequent patient selection criteria noted in history.

Restriction: Traditional DMARD usage was switched to trigger a 'not medically necessary' denial per documented policy history entries.

Update: Background information updated to reflect FDA label changes, as recorded in policy history.

Recorded coverage-related changes (policy history)

Coverage decisions and criteria updated via committee reviews; specific criteria include required trials and changes in medical necessity status for traditional DMARDs.

Requirement recorded: Trial and failure of Humira or Enbrel required for RA prior to upadacitinib coverage.

Change recorded: Traditional DMARD usage classified as not medically necessary following label changes.

Indication added: Psoriatic arthritis documented as an FDA‑approved indication with patient selection criteria.

Policy history coverage criteria

Historical coverage criteria and changes logged in committee reviews

Policy history documents addition of trial/failure requirement for Humira or Enbrel in RA and clarifies that other TNF failures may be accepted in lieu where applicable.

Recorded policy-history coverage updates

Historical coverage criteria changes introduced via Medical Policy Committee and Implementation Committee approvals.

Added requirement: For rheumatoid arthritis, trial and failure of Humira or Enbrel required (other TNF failures may substitute where clarified).

Determination recorded: Traditional DMARD usage switched to not medically necessary owing to label changes.

Addition: Coverage criteria added for new FDA indications including atopic dermatitis and psoriatic arthritis with associated selection criteria.

Recorded coverage changes and clarifications

Policy history entries adding or clarifying coverage requirements and indications for upadacitinib.

Requirement: Trial and failure of Humira or Enbrel required for rheumatoid arthritis (policy history entries); other TNF failures may count in lieu where applicable.

Coverage additions recorded: Psoriatic arthritis and atopic dermatitis added as FDA‑approved indications with updated criteria.

Denial rule: Traditional DMARD usage switched to not medically necessary due to label changes, as noted in history.

Extracted policy criteria from history section

Policy updates introduced requirements and criteria tied to new FDA indications and prior‑treatment trials.

Requirement recorded repeatedly: Trial and failure of Humira or Enbrel required for rheumatoid arthritis in certain updates.

Policy change: Traditional DMARD usage changed to a not medically necessary denial due to label changes.

Clarification: Other TNF failures can count in lieu of a trial and failure of Humira or Enbrel where applicable.

Added indications: Psoriatic arthritis and atopic dermatitis added to coverage history with selection criteria.

Policy history criteria changes

Historical coverage modifications and selection criteria changes documented by committee actions.

Added requirement for trial and failure of Humira or Enbrel in rheumatoid arthritis (documented across multiple committee entries).

Clarification recorded: Other TNF failures may be accepted instead of Humira or Enbrel where specified in history entries.

Coverage additions: New FDA‑approved indications (psoriatic arthritis, atopic dermatitis) added with subsequent patient selection criteria.

Coverage status change: Traditional DMARD usage switched to not medically necessary in policy history due to label changes.

Product Identifiers, Codes, and Related Key Values

Product identifiersmixed

No codes listed

No specific procedure or billing codes in this extractmixed

No codes listed

Drugs/formulations mentionedmixed

Brand names and formulations described (Rinvoq tablets, Rinvoq LQ oral solution)

Referencemixed

Rinvoq [package insert]. AbbVie. Updated October 2025

No explicit codes in this sectionmixed

No codes listed

Minimum trial duration for prior therapies — inv-26

Minimum prior-therapy trial durationTypically at least TWO months of continuous therapy for specified prior agents unless clinical evidence or patient history indicates the agent will be ineffective or cause an adverse reaction.

Applies to TNF inhibitorsFailure of a TNF inhibitor (e.g., adalimumab, etanercept, certolizumab, golimumab, infliximab) is defined after at least TWO months of therapy unless clinically inadvisable.

Applies to certolizumab/other biologics in nr-axSpAFor non-radiographic axial spondyloarthritis, failure of certolizumab pegol is defined after at least TWO months of therapy unless clinically inadvisable.

NSAID trials in nr-axSpAnr-axSpA requires at least TWO months of continuous therapy with at least TWO different oral NSAIDs at prescription strength before advancing, unless clinically inadvisable.

Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Verify member benefits and medical necessity before requesting prior authorization

Coverage is available only when benefits exist in the member’s contract/certificate and the member meets the Company’s medical necessity criteria; coverage eligibility will be considered only when all listed patient selection criteria for the requested indication are met.

Prior Authorization

Meet and document all initial authorization clinical criteria

For initial authorization, confirm the diagnosis and indication-specific entry criteria are met (including age/weight/formulation limits where stated) and document failure of required prior therapies such as traditional DMARDs; requests will be denied as not medically necessary if these selection criteria are not met.

Example: RA — diagnosis of moderately to severely active RA, age ≥18, and failed one or more traditional DMARDs (e.g., methotrexate).
Example: PsA — diagnosis of active psoriatic arthritis, age ≥2, product-specific age/weight limits, and failed one or more traditional DMARDs.

Definitions and Terms

Investigational/Experimental — inv-54

Investigational/Experimental servicesInvestigational or experimental services are not covered, including any drug, device, procedure, or service provided under the investigational arm of a clinical trial or clinical study.

Exclusion from benefitsSuch investigational services are excluded from coverage under member benefits unless the contract expressly provides otherwise.

Coverage condition — inv-55

Contract benefits requiredCoverage is provided only if benefits are available in the member's contract/certificate.

Medical necessity requirementCoverage also requires meeting the policy's medical necessity criteria and guidelines.

Dual condition for eligibilityBoth contract benefit availability and fulfillment of medical necessity criteria must be satisfied for coverage to be considered.

Initial Authorization Requirements

Initial therapy requirements

Initial authorization requires meeting all listed diagnosis‑specific criteria.

Patient has the specified diagnosis per indication (RA, PsA, AD, UC, CD, AS, nr‑axSpA, pJIA, GCA).

Age and formulation/weight criteria met per indication (e.g., RA ≥18; PsA ≥2 with Rinvoq LQ <18 or Rinvoq tablets ≥30 kg; AD ≥12; pJIA ≥2 years).

Failed treatment with one or more traditional DMARDs (e.g., methotrexate) unless clinical evidence or history indicates contraindication or likely ineffectiveness.

Where specified, failed treatment with etanercept (Enbrel) OR adalimumab (Humira or listed biosimilars) after ≥2 months of therapy; failure of another TNF inhibitor also counts when noted.

Requested drug is NOT being used in combination with other biologic DMARDs, other JAK inhibitors, potent immunosuppressants, apremilast, or tofacitinib.

Requirements to Continue Therapy

Continuation therapy requirements

Continuation authorizations require prior approval and demonstration of clinical benefit compared to baseline.

ALL of the following

Patient has received an initial authorization for the requested indication
Patient has experienced a beneficial clinical response from baseline as evidenced by improvement in objective measures or clinical signs/symptoms (examples depend on indication such as ACR endpoints, ASDAS/BASDAI, mMS/endoscopic findings, fecal/serum markers, or specific AD improvement measures)
Drug not used concomitantly with other biologic DMARDs, other JAK inhibitors, potent immunosuppressants, apremilast, or tofacitinib

Continuation therapy requirements

Continuation requires documented benefit.

Prior Therapy and Step Requirements

Indication	Required prior agent(s) before coverage
Rheumatoid arthritis	Failed ≥1 traditional DMARD (e.g., methotrexate) AND failed etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (failure of another TNF inhibitor also counts)
Psoriatic arthritis	Failed ≥1 traditional DMARD (e.g., methotrexate) AND failed etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (failure of another TNF inhibitor also counts)
Polyarticular juvenile idiopathic arthritis (pJIA)	Failed ≥1 traditional DMARD (e.g., methotrexate) AND failed etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (failure of another TNF inhibitor also counts)

Indication	Step requirement (trial and failure)
Ulcerative colitis	Failed a TNF inhibitor after ≥2 months OR failed at least one conventional therapy (corticosteroid, azathioprine, or 6‑MP) if TNF inhibitor is clinically inadvisable
Ankylosing spondylitis	Failed NSAIDs (unless clinically inadvisable) AND failed etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (failure of another TNF inhibitor counts)
Non-radiographic axial spondyloarthritis	Failed ≥2 months continuous therapy with ≥2 different oral NSAIDs AND failed certolizumab pegol (Cimzia) after ≥2 months
Crohn's disease	Failed a TNF inhibitor after ≥2 months OR failed at least one conventional therapy (corticosteroid, azathioprine, or 6‑MP) if TNF inhibitor clinically inadvisable

Indication group	Lower-line therapies that must be tried and failed
Rheumatoid arthritis / Psoriatic arthritis	Failed ≥1 traditional DMARD (e.g., methotrexate) AND failed etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (failure of another TNF inhibitor counts)
Polyarticular juvenile idiopathic arthritis	Failed ≥1 traditional DMARD (e.g., methotrexate) AND failed etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (failure of another TNF inhibitor counts)
Giant cell arteritis / Other inflammatory indications	Failed indicated conventional systemic therapy for the condition (e.g., systemic corticosteroids for GCA) unless contraindicated

Indication	Required NSAID trial
Non-radiographic axial spondyloarthritis	Trial of at least two different oral NSAIDs at prescription strength (≥2 months of current continuous therapy) unless clinically inadvisable

Indication	Prior systemic therapy requirement
Ulcerative colitis and Crohn's disease	Per 2025 FDA labeling clarification: patient should have received at least one approved systemic therapy prior to treatment with Rinvoq when TNF blockers are not clinically appropriate

Context	Policy history / step placement
Policy history entries (committee actions)	Multiple history entries document addition of a requirement for trial and failure of Humira (adalimumab) or Enbrel (etanercept) in rheumatoid arthritis prior to coverage consideration

Indication	Required prior biologic before upadacitinib
Rheumatoid arthritis	Failure of etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (a different TNF inhibitor failure also counts) — added in policy history as requirement prior to upadacitinib

Policy-history note	Step / requirement
Medical Policy Committee / Implementation Committee entries	Recorded addition: trial and failure of Humira or Enbrel required for rheumatoid arthritis; other TNF failures may substitute where applicable

Reference	Prior trial/failure requirement
Policy history summaries (03/2022 entries)	Added requirement for trial and failure of Humira or Enbrel in rheumatoid arthritis; clarification that other TNF failures can count in lieu

Historical note	Biologic trial requirement
Policy history (committee approvals)	Requirement recorded for trial and failure of Humira or Enbrel before upadacitinib coverage in certain RA criteria; other TNF failures may be acceptable where applicable

Indication	Specific prior therapy required
Rheumatoid arthritis	Failed one or more traditional DMARDs AND failed etanercept (Enbrel) OR adalimumab (Humira) after ≥2 months (other TNF failure counts)

Indication	Prior trial/failure required
Ulcerative colitis	Failed a TNF inhibitor after ≥2 months OR failed conventional therapy (corticosteroid, azathioprine, 6‑MP) if TNF inhibitor clinically inadvisable
Crohn's disease	Failed a TNF inhibitor after ≥2 months OR failed conventional therapy (corticosteroid, azathioprine, 6‑MP) if TNF inhibitor clinically inadvisable; per 2025 FDA update, at least one approved systemic therapy is required when TNF blockers are not appropriate

Policy history reference	Prior trial/failure entry
Policy history (multiple committee reviews)	Repeated entries note requirement for trial and failure of Humira or Enbrel in rheumatoid arthritis prior to coverage

Policy-history summary	Mandatory prior step
Committee review notes (05/2022 entries)	Updated policy records a mandatory trial and documented failure of Humira or Enbrel for rheumatoid arthritis in specified criteria; other TNF failures may substitute where allowed

Policy Summary

PayerBlue Cross Blue Shield - Louisiana

Policyupadacitinib (Rinvoq, Rinvoq LQ) coverage

Policy CodePolicy 00692

Change TypeMaterial updates to prior‑therapy and DMARD denial rulesnew FDA indications added

Effective DateJul 1, 2026

Last ReviewApr 16, 2026

Next Review DateApr 1, 2027

Key ActionRequire documented trial and failure of Humira or Enbrel for rheumatoid arthritis prior to coverage consideration.

SourceLink

On This Page

Patient has a negative TB test (e.g., PPD, blood test) prior to treatment

Continuation: patient has received an initial authorization and has experienced a beneficial clinical response from baseline evidenced by improvement in objective measures (e.g., fecal or serum inflammatory markers, endoscopic findings, reduced corticosteroid use) or symptoms (pain, fatigue, stool frequency, rectal bleeding); drug not used in combination with disallowed agents.

Patient has a negative TB test prior to treatment

Continuation: prior authorization required and patient experienced beneficial clinical response from baseline evidenced by improvement in objective measures (e.g., ASDAS, BASDAI, inflammatory markers) or clinical signs/symptoms; drug not used in combination with disallowed agents.

Patient has a negative TB test prior to treatment

Continuation: prior authorization required and patient experienced beneficial clinical response from baseline evidenced by improvement in objective measures (e.g., fecal or serum inflammatory markers, endoscopic findings, reduced corticosteroid use) or symptoms; drug not used with disallowed agents.

Requested drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib

Patient has a negative TB test prior to treatment

Continuation: prior authorization granted; documented beneficial clinical response from baseline (improved joint symptoms, decreased steroid dose, improved function); drug not used with other biologic DMARDs or potent immunosuppressants.

Weight thresholds for Rinvoq vs Rinvoq LQ — inv-27

Rinvoq (extended‑release tablets) weight thresholdFor pediatric polyarticular JIA requests, Rinvoq tablets require patient weight ≥30 kilograms.

Rinvoq LQ (oral solution) pediatric weight‑band dosingRinvoq LQ recommended pediatric dosing by weight: 10 kg to <20 kg = 3 mg twice daily; 20 kg to <30 kg = 4 mg twice daily; ≥30 kg = 6 mg twice daily.

Formulation non‑substitutableRinvoq LQ oral solution is not substitutable with Rinvoq extended‑release tablets (different formulations and dosing).

Required prior biologic trial — inv-28

Required prior biologic trial for RA/PsA/JIAPolicy requires trial and failure of etanercept (Enbrel) OR adalimumab (Humira) after at least TWO months of therapy prior to coverage consideration; failure of another TNF inhibitor counts as well.

Other TNF failures allowedClarification in policy history indicates other TNF inhibitor failures may be accepted in lieu of Humira or Enbrel where applicable.

Applied across multiple indicationsThis trial/failure requirement is referenced for rheumatoid arthritis, psoriatic arthritis, polyarticular JIA, ankylosing spondylitis and related criteria where a prior TNF trial is specified.

Prior Authorization

Document prior approval and clinical benefit for continuation requests

For continuation authorization, ensure prior authorization was granted and provide documentation of clinical benefit compared to baseline (improvement in signs/symptoms or objective measures); also confirm the drug is not being used with prohibited concomitant immunosuppressive therapies.

Continuation requires evidence of beneficial clinical response from baseline (e.g., decreased joint pain, improved function, or objective lab/endoscopic improvements where applicable).
Atopic dermatitis continuation requires at least 6 months of therapy and demonstration of clinical benefit per listed measures.

Denial Risk

Avoid and confirm absence of prohibited concomitant therapies

Do not document or request coverage for concomitant use with other biologic DMARDs, other JAK inhibitors, or potent immunosuppressants — requests for therapy used in combination with these agents are exclusionary.

Examples of disallowed concomitant agents: adalimumab (Humira) or etanercept (Enbrel), other JAK inhibitors (tofacitinib, ruxolitinib, abrocitinib), azathioprine, cyclosporine, apremilast.
Requests that include concomitant use with these agents will be denied as not medically necessary.

Prior Authorization

Request prior authorization only when all indication-specific selection criteria are met

Submit a prior authorization request only when all patient selection criteria for the specific indication are met; the policy considers coverage when the complete set of criteria (initial and continuation as applicable) is documented.

The Company will consider coverage only when ALL listed patient selection criteria for the requested indication are satisfied.
Initial and continuation authorizations each have their own required criteria per indication and must be met as stated.

Prior Authorization

Provide prior approval details and evidence of ongoing benefit for continuation

For continuation approvals, provide proof of the original authorization plus clear documentation of a beneficial clinical response from baseline; absence of such evidence will result in denial as not medically necessary.

Continuation requires prior initial authorization.
Provide objective or symptomaticEvidence of improvement (e.g., ACR20, reduced corticosteroid use, improved endoscopy or inflammatory markers) as applicable to the indication.

Documentation Required

Document prior therapies and confirm absence of disallowed combination therapy

Certify that the requested drug is not being used in combination with other biologic DMARDs or potent immunosuppressants and document prior therapy failures (traditional DMARDs and specified biologics) per the indication.

Confirm prior therapies and documented failures (e.g., failed methotrexate or other traditional DMARDs unless contraindicated).
Confirm failure of specified TNF inhibitors (e.g., etanercept or adalimumab) after at least two months where required.
Document a negative TB test prior to initiation where required.

Prior Authorization

For JIA initial requests, meet age/weight/formulation and prior-therapy requirements

When requesting initial authorization for polyarticular juvenile idiopathic arthritis (JIA), document diagnosis, age (≥2 years), formulation-specific limits (Rinvoq LQ if <18 years; Rinvoq tablets only if ≥30 kg), prior traditional DMARD failure, TNF inhibitor failure, and negative TB test.

If requesting Rinvoq LQ, patient must be <18 years; if requesting Rinvoq tablets, patient must be ≥30 kg.
Document failure of one or more traditional DMARDs (e.g., methotrexate) and failure of etanercept or adalimumab after ≥2 months (other TNF failures may count).

Prior Authorization

Continuation: confirm prior approval, clinical benefit, and no prohibited combinations

For continuation in any indication, confirm the patient had prior approval and provide documentation of clinical benefit compared to baseline; continue to avoid prohibited combinations with biologic DMARDs or potent immunosuppressants.

Continuation requires prior authorization and documented improvement from baseline.
Do not continue therapy if it is being used with disallowed concomitant agents.

Prior Authorization

For GCA, require concurrent corticosteroid taper and negative TB test prior to initiation

For giant cell arteritis initial therapy, document use with a tapering corticosteroid regimen and a negative TB test prior to initiation.

Patient must be ≥18 years and using the requested drug in combination with a tapering course of corticosteroids.
Obtain and document a negative TB test (e.g., PPD or blood test) before starting therapy.

Prior Authorization

When TNF blockers are not appropriate for IBD, document prior systemic therapy per FDA update

For ulcerative colitis and Crohn’s disease when TNF blockers are not appropriate, document prior receipt of at least one approved systemic therapy as clarified in the 2025 FDA labeling update.

Per FDA labeling (2025), patients should have received at least one approved systemic therapy prior to Rinvoq when TNF blockers are not clinically appropriate.

Documentation Required

Recognize prior-authority history that added biologic trial requirements and policy changes

Be aware that policy history documents multiple committee actions adding or clarifying prior-trial requirements and changes to medical necessity determinations; this history supports current requirements such as prior biologic trials in RA.

Policy history entries record additions like trial-and-failure requirements for Humira or Enbrel in RA and additions of FDA‑approved indications (e.g., psoriatic arthritis, atopic dermatitis).

Prior Authorization

RA: document trial and failure of Humira or Enbrel per policy history

Historical policy changes added a requirement for trial and failure of adalimumab (Humira) or etanercept (Enbrel) for rheumatoid arthritis prior to coverage consideration.

Policy history shows the trial-and-failure requirement for Humira or Enbrel in rheumatoid arthritis was added in committee updates.

Denial Risk

Traditional DMARD-only therapy may be deemed not medically necessary under updated policy

Note that the policy position was changed to designate traditional DMARD use in some contexts as not medically necessary following FDA label changes; requests relying solely on traditional DMARDs without meeting updated criteria may be denied.

Policy history documents switching traditional DMARD usage to a 'not medically necessary' denial due to label changes.

Prior Authorization

Ensure requests reflect prior-biologic trial requirements added in policy history

Policy history entries record additions of Humira/Enbrel trial-and-failure requirements and updates tied to new FDA-approved indications — ensure requests reflect these documented prior-therapy requirements.

Committee reviews added the Humira/Enbrel trial requirement for RA and added new FDA indications with corresponding patient selection criteria.

Step Therapy

For RA, document TNF trial(s) — Humira/Enbrel or other TNF failures where allowed

Historical committee updates added step requirements (trial and failure of Humira or Enbrel) for rheumatoid arthritis; other TNF inhibitor failures may substitute where the policy clarifies allowance.

The history notes that other TNF failures can count in lieu of Humira or Enbrel in some cases; document which TNF agent failed and duration of therapy (typically ≥2 months).

Prior Authorization

Include Humira/Enbrel trial-and-failure documentation for RA when applicable

Policy history adds or modifies prior authorization criteria tied to FDA indication changes and explicitly requires trial and failure of Humira or Enbrel for rheumatoid arthritis in applicable criteria.

When applicable, include documentation of trial and failure of Humira or Enbrel (or permitted TNF substitute) to support RA coverage requests.

Prior Authorization

Include documented Humira or Enbrel trial/failure for RA prior authorization

Multiple policy entries confirm a requirement for trial and failure of Humira or Enbrel in rheumatoid arthritis; include this prior therapy documentation when relevant to the request.

Policy history repeatedly references adding the Humira/Enbrel trial requirement for RA.

Prior Authorization

If Humira/Enbrel not used, document failure of another TNF inhibitor per allowance

If Humira or Enbrel were not used, document failure of another TNF inhibitor and note that the policy clarifies other TNF failures can substitute in lieu of Humira/Enbrel where applicable.

Policy history clarified that other TNF failures may be accepted instead of Humira or Enbrel in certain situations; document which TNF agent and duration of therapy.

Prior Authorization

RA prior-therapy requirement: document Humira/Enbrel trial details or accepted TNF substitute

Current policy requirements for RA explicitly require a trial and failure of Humira or Enbrel (other TNF failures may count where applicable); include duration and outcome of those trials in the request.

Document that trial duration met the policy threshold (at least TWO months) and describe clinical reason for failure or intolerance.
If applicable, indicate which alternative TNF inhibitor failed and why Humira/Enbrel were not used.

Prior Authorization

Follow updated criteria reflected in policy history for indication additions and prior trials

Policy history summaries note additions of new FDA‑approved indications and the repeated addition of a Humira/Enbrel trial requirement for RA; ensure current requests follow the updated criteria.

Policy history entries document both indication additions (psoriatic arthritis, atopic dermatitis) and the Humira/Enbrel trial requirement additions.

Documentation Required

Include historical prior‑therapy requirements (Humira/Enbrel) in requests where applicable

Policy history entries reiterate added prior‑therapy requirements (Humira/Enbrel) and changes to medical necessity determinations; include these prior-therapy facts in submissions when relevant.

Policy history repeatedly records the Humira/Enbrel requirement and the change to traditional DMARD status in coverage determinations.

Denial Risk

Provide mandatory Humira/Enbrel trial/failure documentation for RA to avoid denial

The requirement for trial and failure of Humira or Enbrel in rheumatoid arthritis appears repeatedly in policy history — when applicable, provide mandatory trial documentation in the prior authorization submission.

Policy history documents the Humira/Enbrel trial requirement across multiple committee actions; submissions lacking this documentation risk denial.

Prior Authorization

Document alternative TNF failures and rationale when Humira/Enbrel were not used

If Humira or Enbrel were not tried, explicitly document the alternative TNF agent that failed and the clinical rationale; policy history clarifies that other TNF failures can substitute where applicable.

State which TNF inhibitor failed (e.g., certolizumab, golimumab, infliximab), duration of therapy (typically ≥2 months), and reason for discontinuation.
Include any clinical justification for substituting other TNF failures for Humira/Enbrel per policy allowance.

Initial (authorization) definition — inv-56

Diagnosis and age requirementsInitial authorization requires the indicated diagnosis and meeting specified age criteria for each indication (e.g., adults ≥18 years for most IBD and axial spondyloarthritis indications; JIA patients ≥2 years).

Prior therapy failuresInitial approval requires documented failure of specified prior therapies per indication (e.g., traditional DMARD(s), specific TNF inhibitors) unless clinically inadvisable.

Exclusion of concomitant disallowed agentsRequested drug must NOT be used in combination with other biologic DMARDs, other JAK inhibitors, potent immunosuppressants, or listed drugs (e.g., apremilast, tofacitinib).

Pre‑treatment TB testingA negative TB test (e.g., PPD or interferon‑gamma release assay) is required prior to initiating therapy.

Continuation (authorization) definition — inv-57

Prior authorization and prior approval requiredContinuation authorization requires that the patient has received an initial authorization (prior approval) before continuation is eligible.

Documented beneficial clinical responseContinuation requires evidence of clinical benefit from baseline (objective measures or symptom improvement) as specified per indication.

Avoidance of disallowed combinationsThe drug must not be used concomitantly with other biologic DMARDs, specified JAK inhibitors, or potent immunosuppressants for continuation eligibility.

Indication‑specific duration and adherenceSome indications (e.g., atopic dermatitis) specify minimum treatment duration and adherence criteria for continuation (e.g., documented benefit over time).

Rinvoq LQ — inv-58

Rinvoq LQ formulationRinvoq LQ is an oral solution formulation of upadacitinib (Rinvoq LQ oral solution).

Pediatric indication for Rinvoq LQRinvoq LQ dosing and indications include pediatric patients 2 years of age and older for certain indications (psoriatic arthritis, pJIA) per labeling and policy notes.

Non‑interchangeable with tabletsRinvoq LQ oral solution is not substitutable with Rinvoq extended‑release tablets (distinct formulation and dosing).

Traditional DMARDs — inv-59

Definition and roleTraditional DMARDs are disease‑modifying anti‑rheumatic drugs used to slow the disease process in rheumatoid arthritis and other inflammatory conditions.

ExamplesExamples include methotrexate, cyclosporine, sulfasalazine, mercaptopurine, and gold compounds.

First‑line useThese agents are referenced as first‑line or conventional therapies whose failure is typically required before advancing to JAK inhibitors in certain indications.

Traditional DMARDs — inv-60

Therapeutic classTraditional DMARDs are agents intended to slow disease progression by modifying immune system activity in rheumatoid arthritis and related inflammatory diseases.

Clinical contextPolicy notes traditional DMARDs as prior therapies whose intolerance or failure may be required prior to authorization of upadacitinib for some indications.

Representative agentsListed representative agents include methotrexate, cyclosporine, sulfasalazine, mercaptopurine, and gold compounds.

Non-radiographic axial spondyloarthritis — inv-61

DefinitionNon‑radiographic axial spondyloarthritis is axial spondyloarthritis not evident on plain radiography; diagnosis is supported by MRI evidence of active sacroiliac inflammation (sacroiliitis on MRI).

Clinical classificationPatients are classified as radiographic or non‑radiographic; non‑radiographic cases require objective MRI evidence of inflammation to support diagnosis.

Treatment contextPolicy requires failed trials of NSAIDs and sometimes biologic therapy prior to advanced therapies for nr‑axSpA.

ACR20 — inv-62

ACR20 definitionACR20 is the American College of Rheumatology criterion representing a 20% improvement used as a primary endpoint in psoriatic arthritis trials.

Use in trialsPolicy references ACR20 as the primary endpoint at week 12 in key PsA Phase 3 trials (PsA‑I and PsA‑II).

Atopic dermatitis disease measures — inv-63

vIGA‑AD definitionvIGA‑AD is the validated Investigator's Global Assessment for Atopic Dermatitis; trials used a baseline vIGA‑AD ≥3 to define moderate‑to‑severe disease.

EASI and EASI‑75EASI is the Eczema Area and Severity Index; EASI‑75 denotes at least 75% improvement in EASI score from baseline and is a primary endpoint in AD trials.

Trial entry criteriaAD trials required vIGA‑AD ≥3, EASI ≥16, BSA ≥10%, and Worst Pruritus NRS ≥4 at baseline for enrollment.

Modified Mayo score (mMS) — inv-64

Modified Mayo score (mMS)mMS is a 3‑component Mayo score (stool frequency, rectal bleeding, endoscopy findings) used to assess ulcerative colitis disease activity and define clinical remission in trials.

Use in UC trialsUC induction trials (UC‑1/UC‑2) used mMS to define clinical remission at week 8 as the primary endpoint.

ASAS40 — inv-65

ASAS40 definitionASAS40 is the Assessment of SpondyloArthritis International Society 40% response criterion used as a primary endpoint in ankylosing spondylitis and axial spondyloarthritis trials.

Use in trialsPolicy cites ASAS40 as the primary endpoint at week 14 in ankylosing spondylitis and nr‑axSpA trials.

Not medically necessary — inv-66

'Not medically necessary' denial termThe policy uses the term 'not medically necessary' to indicate when requests will be denied if selection criteria or continuation evidence are not met.

Historical applicationPolicy history documents that certain uses (e.g., traditional DMARD rules) were switched to trigger 'not medically necessary' denials following label changes.

Not medically necessary — inv-67

Alternate reference for 'not medically necessary'Policy history repeatedly references 'not medically necessary' denials, particularly in relation to traditional DMARD usage after label changes.

Committee approvals contextMedical Policy Committee and Implementation Committee entries in the history note these 'not medically necessary' determinations alongside added prior‑trial requirements.

Trial and failure of Humira or Enbrel in RA — inv-68

Trial and failure of Humira or Enbrel (policy term)Policy history explicitly added a requirement for trial and failure of Humira (adalimumab) or Enbrel (etanercept) in rheumatoid arthritis prior to coverage consideration.

Documented in multiple history entriesThis addition appears repeatedly in Medical Policy Committee and Implementation Committee history entries (dates noted in 2021–2022).

Traditional DMARD usage switched to not medically necessary — inv-69

Traditional DMARDs policy‑history changePolicy history notes that traditional DMARD usage was switched to a 'not medically necessary' denial due to label changes.

Repeated documentationThis change is recorded across multiple Medical Policy Committee/Implementation Committee entries in the policy history.

Traditional DMARDs — inv-70

Traditional DMARDs — additional referenceTraditional DMARDs are defined and listed (methotrexate, cyclosporine, sulfasalazine, mercaptopurine, gold compounds); policy history ties their role to prior‑therapy requirements and changed denial status.

Role in authorizationFailure of one or more traditional DMARDs is cited as an initial authorization requirement for several indications unless clinically inadvisable.

Traditional DMARD usage — inv-71

Policy‑history note on DMARD usageHistory entries document that traditional DMARD usage was changed to a not medically necessary denial and that this was associated with FDA label updates and committee reviews.

Implication for coverageThe history indicates denial rules were tightened for circumstances involving traditional DMARDs following label changes.

Traditional DMARDs — inv-72

Policy stance changed to not medically necessaryMultiple history entries state traditional DMARD usage was switched to a 'not medically necessary' denial due to label updates, affecting authorization decisions.

Recorded with committee approvalsThe change is documented alongside Medical Policy Committee and Implementation Committee approvals and date references.

Not medically necessary (as applied to traditional DMARD usage) — inv-73

'Not medically necessary' applied to DMARD usagePolicy history explicitly states that traditional DMARD usage was switched to a 'not medically necessary' denial in the policy record.

Effect on prior‑therapy requirementsThis history entry accompanies additions of prior biologic trial requirements (Humira/Enbrel) and other indication updates.

Traditional DMARD usage — inv-74

DMARD denial due to label changesPolicy history repeatedly records that traditional DMARD usage was moved to a not medically necessary denial because of FDA label changes.

Documented across multiple reviewsThis action appears in several committee review entries and implementation approvals in the history.

Therapeutic trial requirement — inv-75

Therapeutic trial requirement — Humira/EnbrelPolicy history and step‑therapy sections record a therapeutic trial and documented failure of Humira (adalimumab) or Enbrel (etanercept) as a requirement prior to upadacitinib for rheumatoid arthritis in multiple entries.

Alternative TNF failure allowanceClarifications indicate other TNF inhibitor failures may be accepted in lieu of Humira or Enbrel where applicable.

Repeatedly noted in historyThis requirement is referenced repeatedly across Medical Policy Committee and Implementation Committee history entries (2021–2022).

Patient has a negative TB test (e.g., PPD or blood test) prior to initiating treatment where indicated.

For ulcerative colitis and Crohn's disease, FDA labeling (2025) clarifies patients should have received at least one approved systemic therapy prior to treatment when TNF blockers are not clinically appropriate.

Initial therapy requirements per indication

Initial authorization criteria per indication include diagnosis, age limits, required prior therapy failures, exclusion of combination use, and negative TB test.

ALL of the following

Diagnosis and age criteria as specified per indication
Required prior therapy failure(s) specific to the indication (e.g., TNF inhibitor, NSAIDs, certolizumab, conventional therapies) after ≥2 months where specified unless clinically inadvisable
Drug not used in combination with other biologic DMARDs, potent immunosuppressants, apremilast, or tofacitinib
Negative TB test prior to initiation where indicated

Failure durations referenced: typically at least TWO months of therapy unless clinical evidence suggests ineffectiveness or adverse reaction.

Initial therapy

Initial therapy requirements are diagnosis‑specific and include age/weight/formulation limits, prior therapy failures, TB testing, and avoidance of disallowed combinations.

ALL of the following

Diagnosis‑specific requirement satisfied
Age and weight/formulation restrictions met (e.g., JIA ≥2 years; Rinvoq tablets ≥30 kg; Rinvoq LQ for pediatric use under 18 as specified)
Failed traditional DMARDs and indicated biologic(s) per indication unless contraindicated
Negative TB test prior to initiating therapy
Not used in combination with other biologic DMARDs or potent immunosuppressants

Requests that do not meet these initial authorization criteria will be denied as not medically necessary per Company requirement.

Initial therapy and trial evidence

Clinical trial evidence and recommended dosing summarized for initial use.

Recommended Rinvoq adult dose for most indications is 15 mg once daily (trials also studied 30 mg).

Ulcerative colitis induction regimens in trials used 45 mg once daily for 8 weeks; Crohn's disease induction used 45 mg once daily for 12 weeks; maintenance studied at 15 mg and 30 mg.

Multiple Phase 3 randomized controlled trials support efficacy across indications (RA, PsA, AD, UC, CD, AS, nr‑axSpA, pJIA, GCA).

Atopic dermatitis trials used entry criteria consistent with policy (vIGA‑AD ≥3, EASI ≥16, BSA ≥10%); trials assessed 16‑week induction with 15 mg and 30 mg doses.

Study dosing and induction regimens

Doses and trial designs reported in clinical studies

Psoriatic arthritis trials assessed Rinvoq 15 mg once daily (also 30 mg in studies); primary endpoints included ACR responses at 12 weeks/24 weeks.

Atopic dermatitis: trials evaluated 15 mg and 30 mg once daily for 16‑week induction with co‑primary endpoints (vIGA‑AD and EASI‑75).

Ulcerative colitis induction: Rinvoq 45 mg once daily for 8 weeks in UC‑1/UC‑2 trials; Crohn's induction: 45 mg once daily for 12 weeks in CD‑1/CD‑2 trials.

ALL of the following

Patient has received prior initial authorization
Documented beneficial clinical response from baseline per indication (examples: objective inflammatory markers, endoscopic improvement, reduced corticosteroid use, improved joint function, reduction in BSA or pruritus for AD) — AD continuation specifically requires at least 6 months of therapy and adherence
Drug not used in combination with disallowed agents

Lack of documented benefit or use with prohibited concomitant therapies will result in denial as not medically necessary.

Continuation therapy

Continuation authorization general rule

ALL of the following

Continuation: prior authorization granted previously
Patient experienced beneficial clinical response from baseline as defined per indication
Requested drug not used concomitantly with other biologic DMARDs or potent immunosuppressants

For atopic dermatitis continuation specifically: patient must have received at least 6 months of therapy, be adherent, and demonstrate clinically meaningful benefit (two or more listed improvements).