CurrentUnitedHealthcarePolicy N/A

Rinvoq (upadacitinib) prior authorization and medical necessity

Rules for prior authorization, initial approval, and reauthorization of Rinvoq (upadacitinib) oral formulations for UnitedHealthcare members, covering multiple labeled indications (rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis) and who may prescribe. Affects prescribers and payers when seeking coverage.

Policy Summary

PayerUnitedHealthcare

PolicyRinvoq (upadacitinib) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeRoutine update — no material coverage changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific documentation, prior therapy trial details or documented needle-phobia, and evidence of positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

prohibitedcombination therapy

multiplecovered indications

allowedneedle-phobia exception

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

pediatric applicability

Coverage Criteria for Rinvoq (upadacitinib)

Initial Therapy - Rheumatoid Arthritis

Covered when ALL of the following are met

RA diagnosis: Diagnosis of moderately to severely active rheumatoid arthritis

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Prior therapy - pathway A or B: One of the following: (a) Both: i) history of failure to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated (document drug, date, duration) AND ii) history of failure, contraindication, or intolerance to at least one TNF inhibitor; OR (b) prior treatment with a systemic targeted immunomodulator FDA‑approved for RA as documented by claims/medical records; OR (c) documented needle‑phobia meeting DSM‑V‑TR 300.29

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Current user / sample limitation: If patient is currently on Rinvoq, provide claims or medical records documenting date and duration of therapy; patient must not have been established on therapy via a manufacturer supplied sample or AbbVie Rinvoq Complete program assistance

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Combination therapy exclusion: Patient is not receiving Rinvoq in combination with a systemic targeted immunomodulator for the same indication (e.g., adalimumab, certolizumab, etanercept, abatacept, golimumab, tofacitinib) or a potent immunosuppressant (e.g., azathioprine or cyclosporine)

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Prescriber requirement: Prescribed by or in consultation with a rheumatologist

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Reauthorization - Rheumatoid Arthritis

Covered when ALL of the following are met

Response documentation: Documentation of positive clinical response to Rinvoq therapy

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Combination therapy exclusion: Patient is not receiving Rinvoq in combination with a systemic targeted immunomodulator for the same indication or a potent immunosuppressant (e.g., azathioprine or cyclosporine)

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Initial Therapy - Psoriatic Arthritis

Covered when ALL of the following are met

PsA diagnosis: Diagnosis of active psoriatic arthritis

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Prior therapy - pathway A or B: One of the following: (a) Both: i) history of failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated (document date and duration) AND ii) history of failure, contraindication, or intolerance to at least one TNF inhibitor; OR (b) prior treatment with a systemic targeted immunomodulator FDA‑approved for psoriatic arthritis documented by claims/records; OR (c) documented needle‑phobia meeting DSM‑V‑TR 300.29

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Current user / sample limitation: If patient is currently on Rinvoq or Rinvoq LQ, document date and duration of therapy and verify patient was not established via a manufacturer supplied sample or AbbVie Rinvoq Complete assistance

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Reauthorization - Psoriatic Arthritis

Covered when ALL of the following are met

Reauth PsA response: Documentation of positive clinical response to Rinvoq or Rinvoq LQ therapy

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Rheumatologic indications (general initial and reauthorization constraints)

Covered when ALL of the following are met:

Rheumatology general: Patient is not receiving Rinvoq or Rinvoq LQ in combination with a systemic targeted immunomodulator or a potent immunosuppressant; patient has not been established on therapy via a manufacturer supplied sample or AbbVie Rinvoq Complete program; prescribed by or in consultation with a rheumatologist or dermatologist as specified per indication; authorization will be issued for 12 months.

Atopic dermatitis — Initial authorization

Covered when ALL of the following are met:

Diagnosis of moderate-to-severe chronic atopic dermatitis

Topical therapy trials: History of failure, contraindication, or intolerance to two topical therapy classes (medium-to-very-high potency topical corticosteroid, topical calcineurin inhibitor, or crisaborole); document drug and dates

Systemic therapy requirement: Either: (a) submission of medical records documenting a 3-month trial of a systemic drug for atopic dermatitis with physician attestation of inadequate control; OR (b) physician attests that FDA‑approved chronic systemic atopic dermatitis therapies are inadvisable (document rationale); OR (c) documented needle‑phobia preventing injectable therapy

Prescriber and combination restrictions: Prescribed by dermatologist, allergist, or immunologist; patient not receiving Rinvoq in combination with specified systemic targeted immunomodulators or potent immunosuppressants; patient was not established via manufacturer supplied sample or AbbVie assistance program; authorization for 12 months

Atopic dermatitis — Reauthorization

Covered when ALL of the following are met:

Response: Documentation of positive clinical response to Rinvoq therapy

Combination restrictions and prescriber: Patient is not receiving Rinvoq in combination with specified systemic targeted immunomodulators or potent immunosuppressants; prescribed by or in consultation with a dermatologist, allergist, or immunologist

Ulcerative colitis — Initial and reauthorization

Initial authorization covered when ALL of the following are met:

Diagnosis of moderately to severely active ulcerative colitis

Prior therapy: Either inadequate response to oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine), OR inadequate response/intolerance to at least one TNF inhibitor, OR prior treatment with a systemic targeted immunomodulator FDA‑approved for UC (document drug/date/duration)

Current therapy exception: If currently on Rinvoq, document claims/records and confirm patient was not established via manufacturer sample or AbbVie Rinvoq Complete program

Ankylosing spondylitis/non-radiographic axial spondyloarthritis — Initial and reauthorization

Initial authorization covered when ALL of the following are met:

Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis

NSAID trial or prior targeted therapy: Either history of failure to two NSAIDs at maximally indicated doses each used for at least 4 weeks unless contraindicated, OR prior treatment with a systemic targeted immunomodulator FDA‑approved for the condition (document drug/date/duration)

TNF inhibitor requirement: History of failure, contraindication, or intolerance to at least one TNF inhibitor, OR documented needle‑phobia preventing injectable therapy

Current therapy and documentation: If currently on Rinvoq, document claims/records of therapy; combination restrictions apply; authorization duration as specified in policy

Initial Therapy — Crohn's disease

Initial authorization — moderately to severely active Crohn's disease

Crohn's diagnosis: Diagnosis of moderately to severely active Crohn's disease

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Prior therapy: One of: (a) history of failure to conventional systemic therapies (corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) unless contraindicated; OR (b) inadequate response or intolerance to at least one TNF inhibitor; OR (c) prior treatment with a systemic targeted immunomodulator FDA‑approved for Crohn's disease; OR (d) documented needle‑phobia

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Current-user provision: If currently on Rinvoq, provide claims or medical records documenting drug, date, and duration; patient must not have established therapy via manufacturer free sample or Rinvoq Complete program assistance

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Reauthorization — Crohn's disease

Response documentation: Documentation of positive clinical response to Rinvoq therapy

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Combination therapy exclusion: Patient is not receiving Rinvoq in combination with a systemic targeted immunomodulator for the same indication or a potent immunosuppressant

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Initial Therapy — Polyarticular JIA

Initial authorization — active polyarticular juvenile idiopathic arthritis

pJIA diagnosis: Diagnosis of active polyarticular juvenile idiopathic arthritis

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Prior therapy or needle phobia or current use: One of: history of failure, contraindication, or intolerance to at least one TNF inhibitor; OR documented needle‑phobia preventing injectable therapy; OR current Rinvoq/Rinvoq LQ therapy with documentation and not established via manufacturer sample/program

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Combination therapy exclusion: Patient is not receiving Rinvoq or Rinvoq LQ in combination with a systemic targeted immunomodulator for the same indication or a potent immunosuppressant (examples listed)

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Prescriber:

Reauthorization — Polyarticular JIA

Reauthorization — polyarticular juvenile idiopathic arthritis

Response documentation: Documentation of positive clinical response to Rinvoq or Rinvoq LQ therapy

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Combination therapy exclusion: Patient is not receiving Rinvoq or Rinvoq LQ in combination with a systemic targeted immunomodulator for the same indication or a potent immunosuppressant

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Initial Therapy — Giant Cell Arteritis

Initial authorization — giant cell arteritis (GCA)

GCA diagnosis: Diagnosis of giant cell arteritis

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Combination therapy exclusion: Patient is not receiving Rinvoq in combination with a systemic targeted immunomodulator for treatment of the same indication or a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

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Prescriber: Prescribed by or in consultation with a rheumatologist

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Reauthorization — Giant Cell Arteritis

Reauthorization — giant cell arteritis

Response documentation: Documentation of positive clinical response to Rinvoq therapy

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Combination therapy exclusion: Patient is not receiving Rinvoq in combination with a systemic targeted immunomodulator for the same indication or a potent immunosuppressant

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Reauthorization

Reauthorization for Rinvoq will be approved when ALL of the following are met:

Reauthorization requirements: (1) Documentation of positive clinical response to Rinvoq therapy AND (2) Patient is not receiving Rinvoq in combination with either: (a) a systemic targeted immunomodulator for treatment of the same indication, or (b) a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

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The policy does not recommend the use of Rinvoq in combination with other Janus kinase (JAK) inhibitors, biologic disease‑modifying antirheumatic drugs (biologic DMARDs) or biological therapies for the same indication, or with potent immunosuppressants (examples include azathioprine and cyclosporine). This limitation of use applies across labeled indications and is stated as a contraindication to combined therapy in the manufacturer labeling and reiterated in the coverage policy.

Concurrent use of Rinvoq or Rinvoq LQ with another systemic targeted immunomodulator for the same indication (examples listed in the policy such as adalimumab, certolizumab, risankizumab, tofacitinib, and others) or with a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil) is excluded from approval and will prevent authorization.

Requests for Rinvoq will be denied or not approved when the patient is receiving Rinvoq concurrently with a systemic targeted immunomodulator for the same indication or with a potent immunosuppressant. The policy lists multiple examples of systemic targeted immunomodulators and specifies potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil) that make combination therapy unacceptable for coverage.

Use of Rinvoq in combination with a systemic targeted immunomodulator for the same indication or with a potent immunosuppressant is an exclusion for both initial approval and reauthorization; such combination therapy is specifically identified as a basis to deny coverage.

Across indications the policy requires that patients be not receiving Rinvoq in combination with another systemic targeted immunomodulator for the same indication or with a potent immunosuppressant. The coverage language is consistent across initial authorization and reauthorization sections and lists examples of agents in both categories; authorization is withheld when these combination therapies are present.

Coding

No explicit CPT/HCPCS/NDC codes listed in this sectionmixed

No codes listed

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for initiation of Rinvoq or Rinvoq LQ. Approval is contingent on meeting indication‑specific criteria including diagnosis, required prior therapy trials or documented contraindications/intolerance, documentation of prior medication trials (drug, date, duration), and prescriber specialty requirements. Authorization will be issued for 12 months (state mandates may apply; CT, KY, and MS may require a 30‑day trial).

Prior authorization is required before initiation.
Document prior trials: drug name, dates, and duration; include claims history or medical records where applicable.
Authorization duration: 12 months (state-specific exceptions: Connecticut, Kentucky and Mississippi may require a 30‑day trial).

Step Therapy

Step Therapy Requirements

Step therapy requirements vary by indication. For rheumatoid arthritis: failure of a ≥3‑month trial of one non‑biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses is required unless contraindicated or intolerant. For psoriatic arthritis: failure of a ≥3‑month trial of methotrexate at maximally indicated dose is required unless contraindicated or intolerant. For atopic dermatitis: failure, contraindication, or intolerance to two classes of topical therapies plus inadequate response to an appropriate systemic biologic or systemic drug trial is required. For other indications (Crohn's disease, ulcerative colitis, ankylosing spondylitis, polyarticular JIA, etc.) prior conventional systemic therapy, failure or intolerance to at least one TNF inhibitor, or prior treatment with an FDA‑approved systemic targeted immunomodulator is required as specified by indication.

Definitions and Exceptions

Limitation of Use — Combination therapy

Limitation of use summaryRinvoq is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, biological therapies for IBD (e.g., ulcerative colitis, Crohn's disease), or potent immunosuppressants such as azathioprine and cyclosporine.

Action on inadequate responseDiscontinue Rinvoq if adequate therapeutic response is not achieved with the 30 mg dosage and use the lowest effective dose to maintain response.

Pediatric noteLimitation applies across labeled pediatric indications (e.g., psoriatic arthritis, polyarticular JIA) as described in product labeling.

Scope of combinations discouragedIncludes combination with other JAK inhibitors, biologic immunomodulators, and biological therapies for ulcerative colitis or Crohn's disease.

Needle‑phobia — Definition and use

Definition

Background

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor approved for multiple inflammatory conditions including moderately to severely active rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis/non‑radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis. The policy reiterates manufacturer limitations of use — notably the recommendation against combining Rinvoq with other JAK inhibitors, biologic immunomodulators, or potent immunosuppressants — and references dosing and therapeutic response guidance from labeling (for example, discontinuing if adequate response is not achieved at 30 mg and using the lowest effective dose to maintain response).

Revision History

2025-11criteria updateLatest

Updated criteria to reflect updated ulcerative colitis and Crohn's disease indications regarding TNF blockers; background and references updated; combination examples and language refined (no change to clinical intent).

2025-07criteria addition

Added Nemluvio as a try/fail drug option for atopic dermatitis.

2025-06criteria addition

Policy Summary

PayerUnitedHealthcare

PolicyRinvoq (upadacitinib) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeRoutine update — no material coverage changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific documentation, prior therapy trial details or documented needle-phobia, and evidence of positive clinical response for reauthorization.

SourceLink

On This Page

Prescriber requirement: Prescribed by or in consultation with a rheumatologist or dermatologist

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Combination therapy exclusion:

Patient is not receiving Rinvoq in combination with a systemic targeted immunomodulator for the same indication or a potent immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate mofetil)

Prescriber: Prescribed by or in consultation with a gastroenterologist

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Prescribed by or in consultation with a rheumatologist

RA: document 3‑month trial of non‑biologic DMARD (drug, date, duration) unless contraindicated.
PsA: document 3‑month methotrexate trial (date, duration) unless contraindicated.
Atopic dermatitis: failure/contraindication to two topical classes and trial of a systemic drug (3 months) or inadequate response to systemic biologic documented.
Inflammatory bowel disease and axial spondyloarthritis: document failure of conventional systemic therapy or TNF inhibitor, or prior targeted immunomodulator exposure.

Note

Alternative Agents / Step‑through Context

Step-through / alternative agent context: Tried/failed alternatives should align with FDA labeling and clinical guidelines. Examples of systemic agents referenced include cyclosporine, azathioprine, methotrexate, mycophenolate mofetil (AAD guidance) and conventional therapies such as corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate for Crohn's disease. Prior use of FDA‑approved systemic targeted immunomodulators for the applicable indication may satisfy step requirements.

Systemic immunomodulators per guideline: cyclosporine, azathioprine, methotrexate, mycophenolate mofetil.
Conventional Crohn's therapies: corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate.
Tried/failed alternatives supported by FDA labeling or guideline references.

Step Therapy

Step Therapy Required Prior to Initiation

Prior to initiation, patients must have either documented failure/intolerance/contraindication to required prior therapies for the specific indication OR be currently receiving Rinvoq/Rinvoq LQ as shown by claims/medical record documentation. Patients established on therapy via manufacturer samples or assistance programs must meet initial authorization criteria as if new to therapy (manufacturer assistance does not qualify as documented prior use).

Acceptable initiation documentation: claims history or medical records documenting drug, date, and duration of prior therapy.
Patients currently on therapy: submit claims history or medical records documenting current Rinvoq/Rinvoq LQ use.
Manufacturer samples or assistance program receipt does not establish prior use for authorization purposes.

Denial Risk

Triggers for Denial

Requests may be denied if the required step‑therapy or prior therapy documentation is not provided or if the patient is receiving disallowed combination therapy. Common denial triggers include lack of documented trials (drug, date, duration), failure to meet indication‑specific prior therapy requirements, or use of a manufacturer sample as sole evidence of prior use.

Denial risk if required prior therapy trials are not documented.
Denial risk if patient established only via manufacturer sample or assistance program without meeting initial criteria.
Denial risk if documentation does not confirm duration or adequacy of prior therapy trials.

Denial Risk

Prohibited Combination Therapy

Prohibited combination therapy: Rinvoq or Rinvoq LQ must not be used in combination with another systemic targeted immunomodulator for the same indication or with a potent immunosuppressant. Examples of systemic targeted immunomodulators that must not be co‑administered for the same indication include adalimumab, certolizumab (Cimzia), etanercept (Enbrel), abatacept (Orencia), golimumab (Simponi), tofacitinib (Xeljanz), vedolizumab (Entyvio), risankizumab (Skyrizi), guselkumab (Tremfya), ustekinumab, secukinumab (Cosentyx), bimekizumab (Bimzelx), ixekizumab (Taltz), mirikizumab (Omvoh), and others depending on indication. Potent immunosuppressants listed as exclusions include azathioprine, cyclosporine, and mycophenolate mofetil.

Do not co‑prescribe Rinvoq/Rinvoq LQ with another systemic targeted immunomodulator for the same indication.
Do not co‑prescribe with potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate).
Examples of excluded agents provided by indication — confirm agent list in the specific indication criteria.

Documentation Required

Reauthorization Documentation

Reauthorization requires submission of documentation demonstrating a positive clinical response to Rinvoq or Rinvoq LQ. Additionally, the member must not be receiving Rinvoq in combination with another systemic targeted immunomodulator for the same indication or with a potent immunosuppressant. Provide objective or clinician‑documented evidence of clinical benefit (e.g., symptom improvement, disease activity measures, decreased steroid use) and updated medication history (drug, dates, duration).

Document positive clinical response to therapy for reauthorization.
Confirm absence of prohibited combination therapy at time of reauthorization.
Provide updated claims history or medical records showing ongoing medication use and clinical response.

Documented specific phobia meeting DSM‑V‑TR 300.29 criteria in which the patient has previously refused injectable therapy or medical procedures.

Acceptable as alternativeA documented needle‑phobia may be used as an alternative to prior injectable biologic therapy requirements when requesting authorization.

Documentation requiredMedical records should reference DSM‑V‑TR 300.29 diagnostic criteria and document prior refusal of injections or procedures.

Manufacturer sample assistance — Establishing current user

Manufacturer samples not sufficientReceipt of manufacturer‑supplied sample in the prescriber's office or participation in the AbbVie Rinvoq Complete program is not acceptable to establish a patient as a current user for authorization purposes.

Implication for requestsPatients established on therapy via samples or assistance must meet initial authorization criteria as if new to therapy.

Documentation expectationFor current‑user requests, claims history or medical records must document drug, date, and duration of therapy; note whether therapy was established via sample/program.

Documented needle‑phobia — Exception to prior injectable therapy

Diagnostic thresholdPatient has previously refused any injectable therapy or medical procedure and meets DSM‑V‑TR 300.29 specific phobia diagnostic criteria.

Use in lieu of prior biologic trialDocumented needle‑phobia can substitute for the requirement to trial injectable biologic therapies when seeking authorization.

Required documentationProvider must submit records documenting the phobia diagnosis and evidence of prior refusals of injectable treatments or procedures.

Potent immunosuppressant — Examples and restriction

Examples of potent immunosuppressantsPolicy lists azathioprine, cyclosporine, and mycophenolate mofetil as examples of potent immunosuppressants.

Combination prohibitionPatients must not receive Rinvoq in combination with a potent immunosuppressant for treatment of the same indication to be eligible for authorization.

Referenced across indicationsThis restriction is reiterated for multiple indications including rheumatologic and gastrointestinal conditions in the policy.

Updated background and added coverage criteria for new indication for Giant Cell Arteritis (GCA); references updated.

2025-04annual review

Annual review conducted; Ebglyss added as an example of systemic drug product and examples updated with no change to clinical intent.

2024-06program update

Added Rinvoq LQ to the program and updated criteria with pediatric indication for psoriatic arthritis and added criteria for polyarticular juvenile idiopathic arthritis; background, references and state mandate footnote updated.

2023-07coverage expansion

Updated not-receiving-in-combination language to reference 'targeted immunomodulator' and added coverage criteria for Crohn's disease; background and references updated.

2022-12coverage addition

Added coverage criteria for non-radiographic axial spondyloarthritis and updated background and references.

2022-07criteria change

Removed age requirement from initial authorization criteria for atopic dermatitis.

2022-06coverage addition

Updated background and added coverage criteria for ankylosing spondylitis; references updated.

2022-05coverage addition

Updated background and added coverage criteria for ulcerative colitis; state mandate updated to include Mississippi.

2022-03coverage addition

Updated background and added coverage criteria for new indication for atopic dermatitis.

2022-02criteria modification

Added step-through requirement of a TNF inhibitor for rheumatoid arthritis and added coverage criteria for psoriatic arthritis per updated label; updated background and references and added footnote supporting FDA-labeled first-line requirements.

2021-12language clarification

Updated conventional DMARD bypass language for rheumatoid arthritis with no change to clinical intent; updated Connecticut/Kentucky footnote.

2021-05criteria clarification

Added coverage criteria for patients previously treated with a biologic DMARD and clarified that submission of medical records is required to bypass non-biologic step therapy when claim history is unavailable.

2021-05-??program launch

New prior authorization/medical necessity program established for Rinvoq (upadacitinib)/Rinvoq LQ (new program entry listed May 2021).

2020-05program creation

Change control record indicates initial program creation for prior authorization/medical necessity for Rinvoq (upadacitinib) in May 2020.