DraftUnitedHealthcarePolicy N/A

Rinvoq (upadacitinib) — Prior Authorization and Coverage Criteria

Defines prior authorization, initial and reauthorization clinical criteria, and limitations of use for Rinvoq and Rinvoq LQ for multiple indications (RA, PsA, AD, UC, Crohn's, JIA, GCA) and specifies exclusions for combination therapy.

Policy Summary

PayerUnitedHealthcare

PolicyRinvoq (upadacitinib) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeCriteria added/updatednew formulation added

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis, prior therapy history (dates/duration), and evidence of positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Policy establishes prior authorization criteria for Rinvoq and Rinvoq LQ including indication-specific requirements and prohibitions on combination therapy with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants.

Added coverage criteria for new indication for Giant Cell Arteritis (GCA).

Added Rinvoq LQ formulation to the program.

Updated not-receiving-in-combination language to reference targeted immunomodulators and provided examples.

10+indications and limitations of use mentioned

Initial+Reauthauthorization pathways defined

Prohibited

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.

combination therapy exclusions

Availableneedle-phobia exception

Rinvoq+LQformulations covered

Coverage Criteria and Clinical Requirements

RA — Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active rheumatoid arthritis (RA).
AND - One of the following
- A
  - History of failure, contraindication, or intolerance to at least one 3-month trial of a non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses, unless contraindicated or not tolerated (document drug, date, and duration).
- Patient has been previously treated with a targeted immunomodulator FDA‑approved for RA (document drug, date, and duration).
Patient is not receiving Rinvoq in combination with specified targeted immunomodulators (e.g., Enbrel/etanercept, Cimzia/certolizumab, Simponi/golimumab, Orencia/abatacept, adalimumab, Xeljanz/tofacitinib, Olumiant/baricitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine).
Prescribed by or in consultation with a rheumatologist.

General Reauthorization

Covered for continuation when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Rinvoq therapy.
Patient is not receiving Rinvoq in combination with specified targeted immunomodulators (examples include Enbrel/etanercept, Cimzia/certolizumab, Simponi/golimumab, Orencia/abatacept, adalimumab, Xeljanz/tofacitinib, Olumiant/baricitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine).
Prescribed by or in consultation with an appropriate specialist (rheumatologist, dermatologist, gastroenterologist, or other specialty as indicated by the condition).

Psoriatic Arthritis — Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of active psoriatic arthritis (PsA).
AND - One of the following
- A
  - History of failure, contraindication, or intolerance to at least one 3‑month trial of methotrexate at maximally indicated dose, unless contraindicated or not tolerated (document date and duration).
  - History of failure, contraindication, or intolerance to at least one TNF inhibitor.
- Documented needle phobia leading to refusal of injectable therapies (refer to DSM‑V‑TR 300.29).

Atopic Dermatitis — Initial Authorization

Initial Authorization for Atopic Dermatitis — Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderate-to-severe chronic atopic dermatitis.
AND - One of the following
- A
  - Failure of a trial of appropriate topical therapies including medium-to-very high potency topical corticosteroid and either crisaborole or a topical calcineurin inhibitor (document dates and duration; or contraindication).
- B
  - Documentation of a 3‑month trial of a systemic FDA‑approved therapy for atopic dermatitis (examples include Dupixent/dupilumab, Adbry/tralokinumab, Ebglyss/lebrikizumab, Nemlivo/nemolizumab) with inadequate control (document drug, date, and duration) or physician attestation that use of all listed FDA‑approved systemic therapies is inadvisable (document rationale).

Atopic Dermatitis — Reauthorization

Reauthorization - Atopic Dermatitis — Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Rinvoq therapy.
Patient is not receiving Rinvoq in combination with specified targeted immunomodulators (e.g., dupilumab, Cibinqo/abrocitinib, Ebglyss/lebrikizumab, Nemlivo/nemolizumab, Xeljanz/tofacitinib, Olumiant/baricitinib, topical ruxolitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).
Prescribed by a dermatologist, immunologist, or allergist.

Psoriatic Arthritis — Initial Authorization (alternate group)

Initial Authorization for Psoriatic Arthritis — Covered when ALL of the following are met:

ALL of the following

Diagnosis of active psoriatic arthritis.
AND - One of the following
- A
  - History of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated or not tolerated (document date and duration).
  - History of failure, contraindication, or intolerance to at least one TNF inhibitor.
- Documented needle phobia leading to refusal of injectable therapies (refer to DSM‑V‑TR 300.29).

Ulcerative Colitis — Initial Authorization

Initial Authorization for Ulcerative Colitis — Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis (UC).
AND - One of the following
- A
  - Inadequate response or intolerance to an adequate course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) prior to initiating biologic/JAK therapy (document drug, date, and duration).
- Previous treatment with a targeted immunomodulator FDA‑approved for UC (document drug, date, duration).
- Documented needle phobia leading to refusal of injectable therapies (refer to DSM‑V‑TR 300.29).

Reauthorization — General

Reauthorization - General — Reauthorization covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Rinvoq or Rinvoq LQ therapy appropriate to the treated condition.
Patient is not receiving Rinvoq or Rinvoq LQ in combination with specified targeted immunomodulators or potent immunosuppressants relevant to the indication (lists of prohibited agents vary by condition).
Prescribed by or in consultation with the appropriate specialist for the condition (e.g., rheumatologist, dermatologist, gastroenterologist).

Ankylosing Spondylitis / Non-radiographic Axial SpA — Initial Authorization

Initial Authorization for Ankylosing Spondylitis / Non-radiographic Axial Spondyloarthritis — Covered when ALL of the following are met:

ALL of the following

Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis with objective evidence of inflammation (when applicable).
AND - One of the following
- A
  - History of inadequate response to at least two NSAIDs used at maximally indicated doses, each for at least 4 weeks, unless contraindicated (document drugs, dates, and duration).
- Previous treatment with a targeted immunomodulator FDA‑approved for ankylosing spondylitis/non‑radiographic axial spondyloarthritis (document drug, date, and duration).

Ankylosing Spondylitis — Reauthorization

Reauthorization - Ankylosing Spondylitis — Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Rinvoq therapy.
Patient is not receiving Rinvoq in combination with specified targeted immunomodulators or potent immunosuppressants (see initial authorization lists).
Authorization will be issued for 12 months when criteria are met.

Crohn's Disease — Initial Authorization

Initial Authorization for Crohn's Disease — Covered when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active Crohn's disease.
AND - One of the following
- A
  - Failure of conventional therapies (document trial and duration) such as corticosteroids, azathioprine, 6‑mercaptopurine, or methotrexate at maximally indicated doses unless contraindicated or not tolerated.
- Previous treatment with a targeted immunomodulator FDA‑approved for Crohn's disease (document drug, date, and duration).
- Documented needle phobia leading to refusal of injectable therapies (refer to DSM‑V‑TR 300.29).

Crohn's Disease — Reauthorization

Reauthorization - Crohn's Disease — Reauthorization — Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Rinvoq therapy.
Patient is not receiving Rinvoq in combination with specified targeted immunomodulators or potent immunosuppressants (see initial authorization lists).
Authorization will be issued for 12 months when criteria are met.

Polyarticular JIA — Initial Authorization

Initial Therapy - Polyarticular Juvenile Idiopathic Arthritis (polyarticular JIA) — Covered when ALL of the following are met:

ALL of the following

Diagnosis of active polyarticular juvenile idiopathic arthritis.
AND - One of the following
- History of failure, contraindication, or intolerance to at least one TNF inhibitor.
- Documented needle phobia leading to refusal of injectable therapies (refer to DSM‑V‑TR 300.29).
Patient is not receiving Rinvoq or Rinvoq LQ in combination with specified targeted immunomodulators (e.g., Enbrel/etanercept, Cimzia/certolizumab, Simponi/golimumab, Orencia/abatacept, adalimumab, Xeljanz/tofacitinib, Olumiant/baricitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).

Combination Therapy Exclusion

Combination therapy exclusion — Use of Rinvoq or Rinvoq LQ in combination with specified targeted immunomodulators or potent immunosuppressants is not permitted:

ALL of the following

Concurrent use with other JAK inhibitors, biologic DMARDs, or specified potent immunosuppressants (examples below) is considered not appropriate and is excluded by policy.
Examples of targeted immunomodulators (non‑exhaustive): Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Stelara (ustekinumab), Skyrizi (risankizumab), Tremfya (guselkumab), Cosentyx (secukinumab), Taltz (ixekizumab), Xeljanz/tofacitinib, Olumiant/baricitinib, Otezla/apremilast, dupilumab, tralokinumab, abrocitinib, lebrikizumab, nemolizumab, topical ruxolitinib.
Examples of potent immunosuppressants (non‑exhaustive): azathioprine, cyclosporine, mycophenolate mofetil.

Polyarticular JIA — Initial Authorization (alternate)

Initial Therapy - polyarticular JIA — Covered when ALL of the following are met for initial authorization:

ALL of the following

Diagnosis of active polyarticular juvenile idiopathic arthritis (repeat entry aligned with polyarticular JIA initial criteria).
Patient is currently on Rinvoq or Rinvoq LQ therapy as documented by claims history or medical records (document date and duration).
Patient has not received manufacturer-supplied samples or AbbVie Rinvoq Complete program assistance as the sole means to establish current use (document if applicable).
Patient is not receiving Rinvoq or Rinvoq LQ in combination with prohibited targeted immunomodulators or potent immunosuppressants (see combination therapy exclusion list).

Reauthorization — Condition-specific

Reauthorization — Reauthorization covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Rinvoq or Rinvoq LQ therapy.
Patient is not receiving Rinvoq or Rinvoq LQ in combination with prohibited targeted immunomodulators or potent immunosuppressants (see combination therapy exclusion list).
Prescribed by or in consultation with the appropriate specialist for the condition.

Giant Cell Arteritis — Initial Authorization

Initial Authorization - Giant Cell Arteritis — Covered when ALL of the following are met for initial authorization:

ALL of the following

Diagnosis of giant cell arteritis.
Patient is not receiving Rinvoq in combination with specified targeted immunomodulators (e.g., Enbrel/etanercept, Cimzia/certolizumab, Simponi/golimumab, Orencia/abatacept, adalimumab, Olumiant/baricitinib, tocilizumab, Xeljanz/tofacitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).
Prescribed by or in consultation with a rheumatologist.

Program-level Rules

Initial Authorization - additional rule applicable across programs:

ALL of the following

Patients who were established on therapy via receipt of manufacturer-supplied samples or AbbVie Rinvoq Complete program assistance must meet initial authorization criteria as if new to therapy (documentation required).
Notwithstanding the above criteria, UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; automated approval processes and supply limits may apply.

Provider Requirements, Documentation, and Step Therapy

Prior Authorization

Prior authorization required — Prior authorization required for initiation and continuation of Rinvoq/Rinvoq LQ

Prior authorization required for initiation and continuation of Rinvoq or Rinvoq LQ. Approval is contingent on meeting diagnosis-specific clinical criteria and required prior therapy trials or documentation of prior targeted immunomodulator use or current Rinvoq/Rinvoq LQ use.

Prior authorization required for all listed indications (e.g., RA, PsA, atopic dermatitis, UC, CD, ankylosing spondylitis/non-radiographic axial spondyloarthritis, polyarticular JIA, giant cell arteritis).
Authorization duration for most indications: 12 months (where specified).

Documentation Required

Indication and prior treatment requirement — Initial authorization requires documented diagnosis and prior treatment documentation

Initial authorization requires a documented diagnosis that matches the indication and completion of required prior treatment steps unless contraindicated or intolerance is documented. For some indications, prior use of an FDA‑approved targeted immunomodulator or biologic may substitute for non‑biologic step therapy when documented by claims history or medical records.

Policy Identifiers and Claims Codes

Policy identifiersmixed

Program Number 2025 P 2202-16

Internal program identifier

Claims/diagnosis codes used for automated approvalsmixed

ICD-10

Diagnosis codes may be used for automated approvals; specific codes not listed in this excerpt

Definitions and Key Terms

inv-47: Rinvoq / Rinvoq LQ — definition of product formulations

Active ingredientUpadacitinib

FormulationsRinvoq extended‑release tablets and Rinvoq LQ oral solution

Indications (examples)Multiple inflammatory indications including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis

inv-48: Needle-phobia — DSM-V-TR definition reference

DSM referenceSpecific phobia diagnostic criteria per DSM‑V‑TR 300.29

ConceptNeedle‑phobia = specific phobia of injections/needles

Use in policy

Background

Background: Rinvoq (upadacitinib) is an oral Janus kinase (JAK) inhibitor indicated for multiple inflammatory conditions across adult and pediatric populations, including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis/non‑radiographic axial spondyloarthritis, Crohn’s disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis. The product is available as extended‑release tablets and as an oral solution (Rinvoq LQ). The policy emphasizes that Rinvoq is not recommended to be used in combination with other JAK inhibitors, biologic immunomodulators, or potent immunosuppressants due to safety concerns.

Policy Summary

PayerUnitedHealthcare

PolicyRinvoq (upadacitinib) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeCriteria added/updatednew formulation added

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis, prior therapy history (dates/duration), and evidence of positive clinical response for reauthorization.

SourceLink

On This Page

Patient has been previously treated with a targeted immunomodulator FDA‑approved for PsA (document drug, date, and duration).

Patient is not receiving Rinvoq or Rinvoq LQ in combination with specified targeted immunomodulators (examples include Simponi/golimumab, Orencia/abatacept, adalimumab, Stelara/ustekinumab, Skyrizi/risankizumab, Tremfya/guselkumab, Cosentyx/secukinumab, Taltz/ixekizumab, Xeljanz/tofacitinib, Olumiant/baricitinib, Otezla/apremilast) or potent immunosuppressants (e.g., azathioprine, cyclosporine).

Prescribed by or in consultation with a rheumatologist or dermatologist.

Documented needle phobia leading to refusal of injectable therapies (refer to DSM‑V‑TR 300.29).

Patient is not receiving Rinvoq in combination with specified targeted immunomodulators (e.g., dupilumab, Adbry/tralokinumab, Cibinqo/abrocitinib, Ebglyss/lebrikizumab, Nemlivo/nemolizumab, Xeljanz/tofacitinib, Olumiant/baricitinib, topical ruxolitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).

Prescribed by a dermatologist, immunologist, or allergist.

Previous treatment with an FDA‑approved targeted immunomodulator for PsA (document drug, date, duration).

Patient is not receiving Rinvoq or Rinvoq LQ in combination with specified targeted immunomodulators or potent immunosuppressants (see list under PsA initial authorization).

Prescribed by or in consultation with a rheumatologist or dermatologist.

Patient is not receiving Rinvoq in combination with specified targeted immunomodulators for UC (e.g., adalimumab, Simponi/golimumab, Stelara/ustekinumab, Xeljanz/tofacitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).

Prescribed by or in consultation with a gastroenterologist.

Documented needle phobia leading to refusal of injectable therapies (refer to DSM‑V‑TR 300.29).

Patient is not receiving Rinvoq in combination with specified targeted immunomodulators (e.g., Enbrel/etanercept, Cimzia/certolizumab, adalimumab, Simponi/golimumab, Xeljanz/tofacitinib, Olumiant/baricitinib) or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).

Prescribed by or in consultation with a rheumatologist.

Patient is not receiving Rinvoq in combination with specified targeted immunomodulators (e.g., adalimumab, Enbrel/etanercept, Cimzia/certolizumab, Simponi/golimumab, Orencia/abatacept, Stelara/ustekinumab, Skyrizi/risankizumab) or potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).

Prescribed by or in consultation with a gastroenterologist.

Prescribed by or in consultation with a rheumatologist.

Provide diagnosis matching the specific indication (e.g., "moderately to severely active rheumatoid arthritis", "active psoriatic arthritis", "moderate-to-severe chronic atopic dermatitis", "moderately to severely active Crohn's disease", "moderately to severely active ulcerative colitis", "active ankylosing spondylitis/non-radiographic axial spondyloarthritis", "active polyarticular juvenile idiopathic arthritis", "giant cell arteritis").
When prior biologic/targeted immunomodulator use is relied upon to bypass non-biologic step therapy, submit claims history or medical records documenting drug name, dates and duration of therapy.
Patients who established therapy via manufacturer samples or AbbVie assistance programs must meet initial authorization criteria as if new to therapy.

Prior Authorization

Initial authorization requirements — Indication‑specific prior therapy and documentation required

Initial authorization criteria are indication‑specific and generally require failure of prior standard therapies (or documented contraindication/intolerance), or documented prior use of an FDA‑approved targeted immunomodulator for the indication, or current documented use of Rinvoq/Rinvoq LQ.

Rheumatoid arthritis (RA): Diagnosis of moderately to severely active RA plus history of failure to a ≥3-month trial of at least one non‑biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated; OR documented prior targeted immunomodulator therapy for RA; OR current Rinvoq use documented by claims/medical records.
Psoriatic arthritis (PsA): Diagnosis of active PsA plus failure of a ≥3‑month trial of methotrexate at maximally indicated dose unless contraindicated; OR failure/contraindication/intolerance to at least one TNF inhibitor; OR documented prior targeted therapy; OR current Rinvoq/Rinvoq LQ use.
Atopic dermatitis (AD): Diagnosis of moderate‑to‑severe chronic AD plus trial and inadequate response to medium‑to‑very‑high potency topical corticosteroids and topical calcineurin inhibitor (document dates) AND either a documented 3‑month trial of a systemic product for AD (e.g., tralokinumab, dupilumab, lebrikizumab, nemolizumab, etc.) with physician attestation of inadequate control, or documentation that all listed FDA‑approved systemic therapies are inadvisable (document drugs and rationale).
Ulcerative colitis (UC): Diagnosis of moderately to severely active UC plus inadequate response to corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) OR documented prior targeted immunomodulator for UC; prescribed by or in consultation with a gastroenterologist.
Crohn's disease (CD): Diagnosis of moderately to severely active CD plus failure of conventional therapies (e.g., corticosteroids, azathioprine, 6‑mercaptopurine, methotrexate) OR documented prior targeted immunomodulator for CD; prescribed by or in consultation with a gastroenterologist.
Ankylosing spondylitis / non‑radiographic axial spondyloarthritis: Diagnosis plus failure of two NSAIDs (each >=4 weeks) at maximally indicated doses unless contraindicated OR prior targeted immunomodulator for the indication; prescribed by or in consultation with a rheumatologist.
Polyarticular juvenile idiopathic arthritis (pJIA): Diagnosis plus history of failure/contraindication/intolerance to at least one TNF inhibitor OR documented prior targeted therapy; prescribed by or in consultation with a rheumatologist.
Giant cell arteritis: Diagnosis of giant cell arteritis (initial authorization criteria as specified).

Denial Risk

Concurrent therapy exclusion — Coverage denied for concurrent use with listed targeted immunomodulators or potent immunosuppressants

Requests will be denied if the patient is receiving Rinvoq or Rinvoq LQ concurrently with specified targeted immunomodulators or potent systemic immunosuppressants. Concurrent use of multiple targeted immunomodulators or potent immunosuppressants is not allowed.

Do not combine Rinvoq or Rinvoq LQ with other targeted immunomodulators (examples include enbrel/etanercept, cimzia/certolizumab, simponi/golimumab, orencia/abatacept, adalimumab, xeljanz/tofacitinib, olumiant/baricitinib, stelara/ustekinumab, skyrizi/risankizumab, tremfya/guselkumab, cosentyx/secukinumab, taltz/ixekizumab, otezla/apremilast, cebinqo/abrocitinib, dupilumab, tralokinumab, etc.).
Do not combine Rinvoq or Rinvoq LQ with potent immunosuppressants such as azathioprine, cyclosporine, or mycophenolate mofetil.

Denial Risk

UC combination therapy exclusion — Coverage can be denied if Rinvoq is combined with listed biologics/targeted agents or potent immunosuppressants

For ulcerative colitis, coverage can be denied if Rinvoq is used in combination with listed biologics/targeted agents or potent immunosuppressants. Prescriptions should be made by or in consultation with a gastroenterologist and required prior therapy trials must be documented.

UC-specific prohibited combinations include TNF inhibitors and other UC biologics/targeted therapies (e.g., adalimumab, golimumab, ustekinumab, tofacitinib) and potent immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil).
Document inadequate response to corticosteroids and/or immunosuppressants when required, or documented prior targeted immunomodulator therapy with dates and duration.

Documentation Required

Required documentation for prior therapy and current use — Submit claims history or medical records documenting prior and current therapy

Submit complete documentation of prior therapies, current use, and reasons for bypassing step therapy when applicable. Claims history alone may be used but medical records are required when claims do not clearly document prior or current targeted immunomodulator use.

Document drug name, dates and duration of prior trials (including DMARDs, NSAIDs, corticosteroids, conventional immunosuppressants, topical and systemic AD therapies, and prior targeted immunomodulators).
When relying on prior use of an FDA‑approved targeted immunomodulator to bypass non‑biologic step therapy, include claims history or medical records that clearly show medication name, start/end dates, and duration.
For current Rinvoq or Rinvoq LQ users, submit claims history or medical records documenting date of initiation and duration of therapy; if current use was established via manufacturer sample or assistance program, the patient must still meet initial criteria.

Documentation Required

Atopic dermatitis trial documentation — Document topical therapy trials and systemic trial or contraindication

Atopic dermatitis initial authorization requires documentation of topical therapy failure and systemic therapy trial or documented contraindication to listed systemic AD agents.

Document trials of topical therapies: medium‑to‑very‑high potency topical corticosteroids (examples: mometasone, fluocinonide), topical calcineurin inhibitors (pimecrolimus, tacrolimus), and crisaborole when applicable (include dates and duration or reason for contraindication).
Provide medical records showing a 3‑month trial of a systemic product for AD (examples: tralokinumab, dupilumab, lebrikizumab, nemolizumab, etc.) with physician attestation that the patient was not adequately controlled, OR documentation that all listed FDA‑approved systemic therapies are inadvisable with rationale.

Step Therapy

Step therapy and alternatives — Document required step therapy trials and acceptable alternatives

When prior therapy is required (step therapy), document dates, duration, and reason for failure/contraindication/intolerance. Acceptable prior therapies vary by indication; claims history may be used to support trials but include clinical notes when needed.

RA/PsA: Trial of non‑biologic DMARDs (e.g., methotrexate) for ≥3 months at maximally indicated doses unless contraindicated; for some PsA and RA scenarios, trial/failure/contraindication to at least one TNF inhibitor may be required.
Ankylosing spondylitis: Trial of two NSAIDs (each ≥4 weeks) at maximally indicated doses unless contraindicated.
Crohn's/UC: Trial/failure of conventional therapies (e.g., corticosteroids, azathioprine, 6‑mercaptopurine, methotrexate) as specified, or documented prior targeted immunomodulator therapy.
Atopic dermatitis: Topical regimen trial plus systemic therapy trial as noted in AD-specific criteria.

Step Therapy

Step therapy and prior biologic/systemic trials — Trials of prior biologic or systemic agents (including TNF inhibitors) required where specified

Some indications require trials of prior biologic or systemic therapies (including TNF inhibitors) before Rinvoq or Rinvoq LQ will be authorized; alternatively, documented intolerance or contraindication to those agents may satisfy the requirement.

Where specified (e.g., RA, PsA, pJIA), document failure, contraindication, or intolerance to at least one TNF inhibitor (examples: etanercept, certolizumab, golimumab, adalimumab) before approval, unless previously treated with another FDA‑approved targeted immunomodulator documented by claims or medical records.
When prior biologic therapy is used to meet criteria, include records showing drug name, start/end dates, and duration to support the request.

Accepted as justification to avoid injectable therapies when documented

inv-49: Documented needle-phobia — criteria for using needle-phobia as justification

Required documentationDocumented diagnosis of specific phobia (needle‑phobia) referencing DSM‑V‑TR 300.29

Prior behaviorEvidence that patient previously refused injectable therapy or medical procedure

Supporting recordsClaims history or medical records documenting current/prior therapy and refusal history where applicable

inv-50: Needle-phobia — further detail about severity and prior refusal of injectables

Severity requirementNeedle‑phobia must be to the degree that the patient previously refused any injectable therapy or medical procedure

Effect on prior therapy requirementWhen documented, needle‑phobia can substitute for prior injectable therapy requirement (e.g., TNF inhibitor) in some indications

VerificationRefer to DSM‑V‑TR 300.29 for specific phobia diagnostic criteria when assessing severity and prior refusals

inv-51: Targeted immunomodulator — examples list

DefinitionTargeted immunomodulators = biologic or targeted agents used to modulate immune response

ExamplesAdalimumab; etanercept (Enbrel); certolizumab (Cimzia); golimumab (Simponi); abatacept (Orencia); tofacitinib (Xeljanz); baricitinib (Olumiant); ustekinumab (Stelara); risankizumab (Skyrizi)

Policy implicationConcurrent use with Rinvoq/Rinvoq LQ is prohibited per combination therapy exclusions

inv-52: Potent immunosuppressant — examples list

DefinitionPotent immunosuppressants = systemic immunosuppressive agents with broad immune‑suppressing effects

ExamplesAzathioprine; cyclosporine; mycophenolate mofetil

Policy implicationUse in combination with Rinvoq/Rinvoq LQ is not recommended and may lead to denial