CurrentmhnPolicy CP.PHAR.443

Upadacitinib (Rinvoq, Rinvoq LQ) coverage

Defines medical necessity criteria, prescribing and prior authorization requirements, dosing limits, and approval durations for upadacitinib (Rinvoq/Rinvoq LQ) across labeled rheumatologic, dermatologic, and gastrointestinal indications for Medicaid members.

Policy Summary

Payermhn

PolicyUpadacitinib (Rinvoq, Rinvoq LQ) coverage

Policy CodePolicy CP.PHAR.443

Change TypeNo material changes

Effective DateDec 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, required prior therapy trials or justification, and indication-specific dosing to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsTypical approval duration

15 mg/dayCommon adult max daily dose

45 mgInduction dose (UC/CD)

≥2 yrsMin pediatric age (some indications)

ProhibitedConcurrent biologics/JAKi

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Covered with criteria (multiple indications)

Covered with criteria (multiple indications) — Rinvoq (upadacitinib) is covered when the specific, indication‑based initial or continued therapy criteria below are met. Criteria consolidate FDA‑approved indications and clinical prior‑therapy expectations; combination use with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants is prohibited.

Covered Indications with criteria

Initial or Continued Therapy Pathway
- Initial Therapy — Disease‑specific criteria
  - Request is for Rinvoq (upadacitinib) and prescribed by or in consultation with the appropriate specialist for the indication (e.g., rheumatologist for RA, GCA, AS/nr-axSpA, pJIA; dermatologist or allergist for atopic dermatitis; gastroenterologist for CD or UC).
  - Patient meets the age requirement for the indication per labeling (e.g., RA/UC/CD/AS/nr-axSpA/GCA: ≥18 years; Atopic Dermatitis: ≥12 years; Psoriatic Arthritis and pJIA: pediatric age thresholds as specified).
  - Documentation of diagnosis and disease activity consistent with the indication (e.g., CDAI or RAPID3 for RA; Mayo or Modified Mayo scores for UC; disease extent/BSA for AD; joint count or pediatric disease activity scores for pJIA).
  - Appropriate prior therapy trials have been completed as specified for the indication (examples consolidated): failure, intolerance, or contraindication to conventional therapies and required biologic/JAK sequencing per indication — e.g., prior trial(s) of methotrexate or other conventional DMARDs for RA/pJIA when applicable; failure of at least one TNF blocker for RA, PsA, AS, nr-axSpA, UC, CD unless TNF blockers are clinically inadvisable (in which case required alternative systemic therapy trials apply); indication‑specific agents (e.g., ustekinumab, adalimumab products, Otezla, Taltz, Actemra) must be trialed per the detailed indication criteria unless contraindicated or previously failed biologic).
  - Rinvoq is not being used concurrently with another biologic DMARD, another JAK inhibitor, anti-CD20 agents, selective co-stimulation modulators, integrin receptor antagonists, or other potent immunosuppressants (e.g., azathioprine, cyclosporine) due to additive immunosuppression and safety concerns. Combination use is excluded (see Section III).
  - Requested dose and regimen are within indication‑specific dosing limits (see Dosage and Administration): generally ≤15 mg once daily for most indications and ages; pediatric Rinvoq LQ and weight‑based dosing applied where specified; higher induction or refractory dosing (e.g., 45 mg induction for UC/CD; up to 30 mg/day for refractory severe disease in adults for UC/CD/AD when justified) only where the policy lists and labeling allow.
- Continued Therapy — Disease‑specific criteria
  - Member is currently receiving Rinvoq via the plan benefit or previously met initial approval criteria, or continuity of care provisions apply (state/product specific).
  - Member demonstrates clinical response to therapy as documented by decreased disease activity scores, improvement in signs/symptoms (e.g., reduction in itching for AD, improved CDAI/RAPID3 for RA, improvement in endoscopic or clinical scores for IBD), or other clinical justification when formal scores are not feasible.
  - No combination use with biologic DMARDs or other JAK inhibitors or the prohibited agents listed in Section III. Continued dosing does not exceed the maximums specified for the indication (e.g., generally 15 mg/day; induction dosing limits and refractory higher dose allowances per indication and labeling).
Operational and safety conditions
- Prescriber must document prior authorization history where referenced (prior authorization may be required for certain comparator agents such as adalimumab products, ustekinumab products, Otezla, Taltz, Actemra, Xeljanz/XR).
- Contraindications and boxed warnings must be reviewed: known hypersensitivity to upadacitinib or excipients; be aware of boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis (see Appendix C).
- Approval durations: initial and continued approvals are generally for 12 months for chronic indications unless otherwise specified (induction durations apply where listed).

Product Availability, Dosing, and Coding References

No explicit CPT/HCPCS/NDC codes in this sectionmixed

No codes listed

Product availability / dosage formsNDC

NDC/Strength

Tablets, extended-release: 15 mg, 30 mg, 45 mg; Oral solution (Rinvoq LQ): 1 mg/mL

Mayo Score thresholds

Mayo Score (full)Mayo Score ≥ 6

Modified Mayo Scoremodified Mayo Score ≥ 5

Mayo Endoscopic ScoreMayo Endoscopic Score ≥ 2

CDAI / RAPID3 requirements for RA

Baseline assessment requiredDocumentation of baseline CDAI or RAPID3 score is required for initial RA approval

Continued therapy — CDAIContinued RA therapy requires evidence of a decrease in CDAI from baseline

Continued therapy — RAPID3If CDAI reassessment is not possible, improvement or similar disease-severity RAPID3 compared with baseline may be submitted as justification

Maximum daily dose by indication / age / weight

Typical adult maximum15 mg per day (and 1 tablet per day) for most adult indications

Higher dose allowanceUp to 30 mg per day (1 tablet per day) may be considered for refractory, severe, or extensive UC or CD

Pediatric weight-based limitsRinvoq LQ oral solution weight-based dosing for pediatric patients (e.g., 6 mg, 8 mg, 12 mg or Rinvoq 15 mg per applicable weight bands) with specified maximums

Maximum daily dose

Standard maximum daily dose15 mg/day for most indications (and 1 tablet per day)

Permitted higher maximumMaximum up to 30 mg/day may be used for some refractory UC or CD maintenance or severe/extensive cases (30 mg PO QD)

Rinvoq LQ pediatric maximumRinvoq LQ oral solution maximum 12 mg/day for pediatric indications when dosed BID (equivalent to specified mg/day limits)

Modified Mayo Score

modified Mayo Score threshold>= 5

ContextModified Mayo Score option added as a documentation option to define moderate‑to‑severe UC in initial criteria

Reference appendixSee Appendix H for supplemental information on modified Mayo Score

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rinvoq (upadacitinib) and approval is contingent on meeting indication-specific criteria, including diagnosis, prescriber specialty, age limits, and prior therapy trials or failures as described in the policy. Requests that exceed indication-specific dosing limits or propose combination use with biologic DMARDs or other JAK inhibitors will be denied.

Prior authorization required for initial and continued therapy for all covered indications (RA, PsA, AD, AS/nr-axSpA, UC, CD, pJIA, GCA).
Prescriber requirements: many indications require prescription by or in consultation with a specialist (e.g., rheumatologist, dermatologist, gastroenterologist).
Approval contingent on meeting indication-specific criteria and documentation (see criteria sections I and II).

Prior Authorization

Prior authorization and dosing limits

Prior authorization and continuation approvals require evidence of prior approval under the benefit or documentation that the member currently meets the policy’s continued therapy criteria. For continued therapy, documentation must show clinical response to Rinvoq (e.g., decrease in CDAI or RAPID3 for RA; reduction in itching/scratching for AD; evidence of clinical response for CD/UC/AS/psA/GCA). Dose increase requests must be justified and must not exceed indication-specific maximums.

Continued therapy: evidence of positive response (disease activity scores or clinician documentation) required.
If request is for a dose increase, new dose must not exceed the maximums listed for the specific indication (e.g., generally 15 mg/day for most adults; AD and IBD have specified higher options with justification).
If member previously met initial criteria or is receiving therapy through Centene benefit, continuity options apply per state/product regulations.

Prior Authorization

Indication-specific dosing and PA

Indication-specific dosing limits and maximum daily doses must be followed. Examples include: adults for many indications — 15 mg once daily (1 tablet per day); ulcerative colitis and Crohn’s disease have induction and maintenance schedules (induction up to 45 mg daily for specified weeks then maintenance 15 mg QD; 30 mg/day may be considered for refractory disease with justification); pediatric oral solution (Rinvoq LQ) dosing by weight for pJIA and pediatric PsA with specific maximums.

Rheumatoid arthritis, AS, nr-axSpA, PsA (adult): 15 mg PO QD, 1 tablet per day (maximum 15 mg/day).
Atopic dermatitis (age ≥12 and ≥40 kg <65 years): start 15 mg PO QD; if inadequate response consider 30 mg PO QD; age ≥65 years max 15 mg/day.
Ulcerative colitis & Crohn’s disease: induction regimens (UC induction 45 mg PO QD for 8 weeks; CD induction 45 mg PO QD for 12 weeks) then maintenance 15 mg PO QD; 30 mg PO QD may be considered for refractory/severe disease with justification.
pJIA and pediatric PsA: Rinvoq LQ oral solution weight-based dosing (e.g., 3 mg BID for 10–<20 kg, 4 mg BID for 20–<30 kg, 6 mg BID for ≥30 kg) with specified maximums; for children ≥30 kg, tablet regimens align with 15 mg PO QD where applicable.

Documentation Required

Required clinical documentation

Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant lab results, disease activity scores, and prior therapy details to demonstrate that the member meets the initial or continued therapy criteria.

Baseline and follow-up disease activity scores where applicable (e.g., CDAI or RAPID3 for RA; Mayo, modified Mayo, or Mayo Endoscopic Score for UC; documentation of high disease activity or baseline joint counts for pJIA).
Clinical notes describing response to prior therapies and to current Rinvoq therapy (e.g., reductions in symptoms, improved ESR/CRP, improved activities of daily living).
Laboratory results and other objective data when relevant (e.g., ESR/CRP).
Failure/intolerance documentation for prior medications (dates, doses, reasons for discontinuation, adverse effects).

Step Therapy

Prior therapy requirements and redirection to preferred agents

The policy requires documentation of prior therapy trials and redirection to preferred agents where applicable. Many indications require trials of conventional DMARDs, TNF inhibitor(s), and other specified biologics before Rinvoq will be approved, unless the member has intolerance, contraindication, or prior biologic failure that allows bypass of conventional steps. Prior authorization may also be required for redirected agents (e.g., adalimumab products, ustekinumab, Actemra, Taltz, Otezla, Xeljanz).

Step therapy: RA often requires MTX trial (≥3 months) and failure of specified agents (e.g., preferred adalimumab product, Actemra, Xeljanz in certain scenarios) unless prior biologic failure permits bypass.
PsA: adults require failure of multiple agents (adalimumab product, Otezla, Taltz, ustekinumab product) unless prior biologic failure allows bypass; pediatric redirection rules apply (e.g., Otezla for certain pediatric ages).
Axial spondyloarthritis/AS: NSAID failure and trials of specified biologics (adalimumab product, Taltz, and Xeljanz in specified circumstances).
IBD (UC/CD): requirement for steroid trial and failure of preferred TNF or ustekinumab products (options include stepping through a preferred adalimumab product or a preferred ustekinumab product for UC per recent updates).
Providers must include dates, durations, doses, and reasons for failure or intolerance for prior agents; failure to document required prior therapy or redirection may result in denial.

Definitions and Clinical Measures

Upadacitinib (Rinvoq, Rinvoq LQ)

Drug classJanus kinase (JAK) inhibitor

IndicationsMultiple inflammatory conditions as specified in policy including RA, PsA, AD, UC, CD, AS, nr-axSpA, GCA, and pJIA

Brand names / formulationsRinvoq (tablets) and Rinvoq LQ (oral solution) — dosing and administration differ by indication and age/weight

CDAI

DefinitionCDAI = clinical disease activity index

UseAppendix references CDAI for baseline assessment and monitoring of RA activity

Score rangeCDAI score ranges from 0 to 76 (see Appendix F)

RAPID3

DefinitionRAPID3 = Routine Assessment of Patient Index Data 3

UseUsed as a baseline or follow‑up assessment for RA when CDAI reassessment is not possible

ScoringRAPID3 score ranges 0–30; interpretation categories provided in Appendix G

JAKi

AbbreviationJAKi = Janus kinase inhibitors

Policy noteCombination use of multiple JAK inhibitors is not authorized per policy (safety risk)

Clinical relevanceUpadacitinib is a member of the JAKi class used across rheumatology, dermatology, and GI indications

MTX or DMARD failure

DefinitionMTX or DMARD failure is defined in Appendix D; examples and guidance on pregnancy and alcohol use included

ConsequencePolicy requires documented failure of MTX or other conventional DMARDs for many indications unless intolerance/contraindication is documented

DocumentationProviders should include prior therapy duration and reasons for discontinuation in supporting documentation

Disease activity scores (appendices)

Included scoresPolicy appendices include RA classification (2010 ACR), CDAI, RAPID3, cJADAS‑10 (JIA), and Mayo/modified Mayo/Mayo Endoscopic scores for UC

PurposeAppendices support assessment of disease severity and documentation requirements for initial and continued therapy

Reference locationsSee Appendices E–J for classification and scoring details

modified Mayo Score ≥5

Thresholdmodified Mayo Score ≥ 5 may be used as an option to define moderate‑to‑severe ulcerative colitis for initial criteria

Policy changeOption for modified Mayo Score ≥5 was added in recent updates to UC initial criteria

See appendixAppendix H contains supplemental information on modified Mayo Score

cJADAS-10

DefinitioncJADAS‑10 = clinical juvenile arthritis disease activity score (10‑joint) for pJIA

Policy updateMinimum cJADAS‑10 ≥ 8.5 requirement for pJIA was removed in recent updates

UseAppendix J provides cJADAS‑10 parameters and interpretation guidance

OpenPayer

Upadacitinib (Rinvoq, Rinvoq LQ) coverage

Coverage Criteria and Medical Necessity

Product Availability, Dosing, and Coding References

Prior Authorization, Documentation, and Step Therapy Requirements

Background and Scope

Definitions and Clinical Measures