CurrentmhnPolicy CP.PHAR.257

Ixekizumab (Taltz)

Defines medical necessity criteria, initial and continuation approval conditions, dosing limits, excluded combination uses, provider documentation requirements, and coding implications for ixekizumab (Taltz) for Medicaid line of business.

Policy Summary

Payermhn

PolicyIxekizumab (Taltz)

Policy CodePolicy CP.PHAR.257

Change TypeRevised (coverage and product updates)

Effective DateSep 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

05.25: For AS, nr-axSpA, and PsO, added bypass of conventional therapies if a member has failed a biologic agent and extended initial approval durations to 12 months for chronic conditions.

RT4 (08.15.24): added new strengths for single-dose prefilled syringe (20 mg/0.25 mL, 40 mg/0.5 mL).

2Q 2026 annual review (01.23.26 / 05.26): no significant changes; references reviewed and updated.

3FDA-approved adult indications listed (PsA, AS, nr-axSpA)

1FDA-approved pediatric indication (PsO ≥6 years)

12Approval duration (initial) months

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Coverage Summary

Policy covers ixekizumab (Taltz) consistent with FDA-approved indications for plaque psoriasis (PsO) in patients aged ≥ 6 years, adult psoriatic arthritis (PsA), adult ankylosing spondylitis (AS), and adult non-radiographic axial spondyloarthritis (nr-axSpA).

Coverage is aligned to the FDA label dosing and indication-specific criteria (including defined induction and maintenance regimens and maximum maintenance dosing of 80 mg every 4 weeks), and requires that patients meet the indication-specific prior therapy requirements (for example, trials of conventional therapies such as NSAIDs for AS/nr-axSpA or methotrexate/cyclosporine/acitretin or phototherapy for PsO) unless the member has previously failed a biologic agent, in which case stepping back to conventional therapy is not required. Initial approvals for chronic indications are set to 12 months.

Key thresholds

Age for PsO≥ 6 years

Age for PsA/AS/nr-axSpA≥ 18 years

NSAID trial for AS/nr-axSpAFailure of at least 2 NSAIDs, each used for ≥ 4 weeks

Methotrexate trial for PsOFailure of ≥ 3 consecutive months of MTX at up to maximally indicated doses

Initial approval duration for chronic indications12 months

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Explicit exclusions: combination use of ixekizumab with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi) is not authorized and is a basis for denial of coverage.

Dose requests that exceed the policy-listed maximum regimens (for example, maintenance dosing above 80 mg every 4 weeks or regimens inconsistent with the indication-specific schedules) are not permitted and may be denied.

Applicable Codes

Informational HCPCS / Unlisted drug codes referencedHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologicals

Provider Actions

Documentation Required

Submit supporting documentation

Provider must submit documentation supporting that the member has met all approval criteria. Acceptable supporting documentation includes office chart notes, laboratory results, or other clinical information demonstrating diagnosis, prior therapy trials or failures, and response to treatment.

Office chart notes
Lab results
Other clinical information (e.g., imaging, specialist consult notes)

Prior Authorization

Prior authorization required

Coverage for ixekizumab is subject to prior authorization. Requests must meet the policy’s stated criteria for the specific indication. Initial approvals for chronic indications (e.g., AS, nr-axSpA, and PsO) are granted for 12 months.

Clinical Evidence & References

Evidence references (as summarized in the brief):

Primary reference: Taltz Prescribing Information, Eli Lilly; August 2024.

Guideline references: AAD‑NPF psoriasis guideline 2019; EULAR psoriatic arthritis 2023 update; ACR/National Psoriasis Foundation PsA guideline 2018; ACR/SAA/SPARTAN axSpA guideline updates.

No trial metric cards are provided in the brief; coverage is based on the prescribing information and guideline sources above.

Background

Background: Ixekizumab (Taltz) is an IL‑17A antagonist indicated for moderate‑to‑severe plaque psoriasis in patients aged ≥ 6 years, and for adult psoriatic arthritis, ankylosing spondylitis, and non‑radiographic axial spondyloarthritis. The policy aligns coverage with FDA indications and label dosing, specifies indication‑specific therapeutic prerequisites (e.g., trials of NSAIDs for AS/nr‑axSpA or trials of methotrexate/cyclosporine/acitretin or phototherapy for PsO), and allows bypassing those conventional therapy steps when a member has previously failed a biologic agent. Initial approval durations for chronic indications are set to 12 months.

Definitions

bDMARDBiological disease-modifying antirheumatic drug

nr-axSpANon-radiographic axial spondyloarthritis

MTXMethotrexate

Revision History

05.25material

For AS, nr-axSpA, and PsO, clarified that members who previously failed a biologic agent need not step back to conventional therapies (biologic failure bypass), and initial approval durations for chronic indications were set/extended to 12 months.

08.15.24non-material

Product availability updated: added new single-dose prefilled syringe strengths (20 mg/0.25 mL, 40 mg/0.5 mL).

01.23.26 / 05.26non-materialLatest