CurrentHealth NetPolicy CPPHAR443

Clinical Policy: Upadacitinib (Rinvoq; Rinvoq LQ)

Pharmacy clinical policy defining medical necessity criteria, dosing limits, prior authorization requirements, and continuation criteria for Upadacitinib (Rinvoq and Rinvoq LQ) across multiple FDA-approved indications for Centene-affiliated Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Upadacitinib (Rinvoq; Rinvoq LQ)

Policy CodePolicy CPPHAR443

Change TypeMultiple revisions (2019-2025)

Effective DateDec 1, 2019

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, disease activity scores) showing the member meets all approval criteria; prior authorization may be required.

SourceLink

POLICY UPDATE CHANGES

Added/updated dosing and indications across multiple FDA approvals including UC, CD, pJIA, nr-axSpA, and adjusted pediatric age limits for AD and PsA.

Removed redirection to preferred adalimumab products for UC per 2024 AGA guidelines and revised redirection to Zeposia with bypass allowance.

For pJIA, removed minimum cJADAS-10 score removed and baseline cJADAS-10 phrasing moved to Appendix J.

Added several preferred and biosimilar agents to preferred lists (e.g., Simlandi, adalimumab-adbm, Stelara biosimilars, Amjevita) across indications.

Reiterated requirement against combination use with a bDMARD or another JAK inhibitor.

Updated dosing tables (oral tablet and oral solution 'LQ') and maximum daily doses by indication and age/weight.

Coverage Summary

Coverage stance: covered_with_criteria. Scope: pharmacy clinical policy defining medical necessity criteria, dosing limits, prior authorization requirements, and continuation criteria for Upadacitinib (Rinvoq and Rinvoq LQ) across multiple FDA‑approved indications for Centene-affiliated Medicaid lines of business. FDA‑approved indications count: multiple (9–10+ listed indications including RA, PsA, pJIA, AD, AS, nr‑axSpA, UC, CD, and GCA). Common dosing limits: generally 15 mg/day and 1 tablet per day (common maximum); some indications permit higher induction or refractory dosing (e.g., UC/CD induction 45 mg; AD or refractory disease up to 30 mg/day). Effective date: 2019-12-01. Last review date: 2025-06-25.

Initial Therapy Criteria (by indication)

Continuation Therapy / Renewal Criteria

Combination Use Prohibition & Exclusions

The policy consistently prohibits concurrent use of Upadacitinib with other JAK inhibitors, biological DMARDs, or potent immunosuppressants due to additive immunosuppression and related safety concerns. Boxed warnings cited in the policy include serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, and the provider actions section specifies that requests will be denied if the member is using Rinvoq concurrently with other bDMARDs or JAK inhibitors or potent immunosuppressants because of increased immunosuppression, risk of neutropenia, and higher risk of serious infections.

Applicable Codes & Cross-references

Policy Reference Numbermixed

CPPHAR443

Clinical Policy Reference Number for Upadacitinib

Related internal policies / cross-referencesmixed

CP PMN.255	No coverage criteria policy (Medicaid) - referenced for formulary drugs
CP PMN.16	Non-formulary policy (Medicaid)
CP PMN.53	Off-label use policy (Medicaid)

Provider Actions & Operational Notes

Prior Authorization

Prior authorization and documentation required

Prior authorization and documentation required. Providers must submit office chart notes, relevant laboratory results, disease activity scores, and other clinical information supporting medical necessity. Prior authorization may also be required for comparator biologics referenced in the criteria (e.g., adalimumab products, ustekinumab, etc.).

Submit office chart notes and progress notes documenting diagnosis and treatment history
Include relevant labs (e.g., CBC, LFTs) and pregnancy status where applicable
Attach prior medication trials, durations, and reasons for discontinuation/failure
PA may be required for comparator biologics (adalimumab, ustekinumab, etc.)

Documentation Required

Baseline disease activity documentation

Clinical Evidence & References

Evidence citations: Prescribing Information — Rinvoq/Rinvoq LQ Prescribing Information, AbbVie Inc.; April 2025. Guideline and society references included in the policy: ACR, EULAR, AGA, AAD, NASPGHAN and other society guidelines (multiple citations and guideline updates listed within the reference section). Note: full trial metrics are not provided in the brief; do not reconstruct or repeat trial metric cards here.

Background & Definitions

Background: Upadacitinib (Rinvoq/Rinvoq LQ) is a Janus kinase (JAK) inhibitor with multiple FDA‑approved indications across adults and pediatrics (including RA, PsA, pJIA, AD, AS, nr‑axSpA, UC, CD, and GCA). The policy highlights boxed safety warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Dosing forms noted in the policy include Rinvoq tablets and Rinvoq LQ oral solution, with indication‑specific dosing examples (e.g., 15 mg PO QD typical adult dose; UC/CD induction 45 mg PO daily; pediatric weight‑based LQ dosing with defined weight bands and maximum daily doses).

Term	Definition
bDMARDs
biological disease-modifying antirheumatic drugs
JAKi
Janus kinase inhibitors
MTX
methotrexate
CDAI
Clinical Disease Activity Index (see Appendix F) — composite index for assessing RA activity with interpretation ranges: remission <2.8; low 2.8–<10; moderate 10–<22; high ≥22.
RAPID3
Routine Assessment of Patient Index Data 3 (see Appendix G) — patient-reported index (function, pain, patient global) with interpretation: <3 remission; 3.1–6 low; 6.1–12 moderate; >12 high.
cJADAS-10
Clinical Juvenile Disease Activity Score (10-joint) composed of parent global assessment (0–10 VAS), count of active joints (max 10), and physician assessment; total range 0–30 with interpretation: <1 inactive; 1.1–2.5 low; 2.51–8.5 moderate; >8.5 high.

Revision History

02.23.21revision

2Q 2021: added combination bDMARDs under Section III; updated CDAI table; added Actemra to redirect options for RA and modified Xeljanz redirection with bypass for cardiovascular risk.

05.22.22revision

2Q 2022: added new FDA indications (PsA, AD, UC, AS); added redirection to Olumiant for RA; reiterated prohibition on combination use across Sections I and II; revised lower age limit for AD to 12 per PI.

05.25.23revision

RT4/2023: added Crohn's disease criteria; removed some prior redirections (Enbrel/Cimzia) and standardized requirement for one adalimumab product across multiple indications.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Upadacitinib (Rinvoq; Rinvoq LQ)

Policy CodePolicy CPPHAR443

Change TypeMultiple revisions (2019-2025)

Effective DateDec 1, 2019

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, disease activity scores) showing the member meets all approval criteria; prior authorization may be required.

SourceLink

On This Page

Documentation Required

Pediatric weight-based dosing

Pediatric weight-based dosing. For Rinvoq LQ pediatric formulations, document the patient's current weight to support dosing within approved weight bands and to justify the selected dose.

Record and attach most recent weight in kg for pediatric patients
Correlate weight to Rinvoq LQ dosing bands (e.g., 10–<20 kg = 6 mg QD; 20–<30 kg = 8 mg QD; ≥30 kg follow adult dosing options as specified)

Billing Rule

Dose limits enforcement

Dose limits enforcement. Ensure requested dose does not exceed per-indication caps; typical maintenance limit is 15 mg once daily (one tablet/day). Higher induction doses for UC/CD (e.g., 45 mg once daily or 1 tablet once daily for induction as listed) or temporary 30 mg/day allowances for certain indications may be permitted with clinical justification—document rationale.

Standard adult maintenance limit: 15 mg per day and 1 tablet per day
Ulcerative colitis induction: may include 45 mg once daily for 8 weeks or 1 tablet once daily for 8 weeks per policy induction language—verify against current PI
Atopic dermatitis and certain scenarios: medical justification may support up to 30 mg/day; document clinical rationale
Pediatric Rinvoq LQ dosing must align with weight bands (see pediatric callout)

Denial Risk

Combination therapy exclusion

Combination therapy exclusion — denial risk. Coverage will be denied if Rinvoq/Rinvoq LQ is used concurrently with other biologic DMARDs, other JAK inhibitors, or potent immunosuppressants (e.g., azathioprine, cyclosporine).

Concurrent use with biologic DMARDs or other JAK inhibitors is not authorized
Concurrent use with potent immunosuppressants such as azathioprine or cyclosporine is not authorized

Prior Authorization

Redirection / step requirements to preferred biologics

Redirection / step requirements to preferred biologics. Providers should follow step therapy and preferred product lists; requests may be redirected to preferred adalimumab or ustekinumab products or to alternative agents (e.g., Zeposia) per the plan's current preferred product list. Bypass allowances and exceptions noted in the revision history may apply—check current formularies and prior authorization rules.

Follow current preferred product lists for adalimumab and ustekinumab prior authorization or step requirements
Alternatives such as Zeposia may be preferred in certain indications—verify plan-specific guidance
Bypass or exception criteria may exist as recorded in revision history; document clinical justification when requesting an exception

04.23.25material_changeLatest

Apr 2025: added requirement for use of one preferred ustekinumab (Stelara) biosimilar for PsA, CD, and UC; for UC removed Zeposia preference and revised step options to include preferred adalimumab or preferred ustekinumab product; updated appendices and preferred product lists; updated dosing/age expansions per multiple FDA approvals.