CurrentPeach State Health PlanPolicy CP.PHAR.257

Clinical Policy: Ixekizumab (Taltz)

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Defines medical necessity criteria, prescriber requirements, dosing limits, and continuation rules for coverage of ixekizumab (Taltz) for Peach State Health Plan (Medicaid) members.

Policy Summary

PayerPeach State Health Plan

PolicyClinical Policy: Ixekizumab (Taltz)

Policy CodePolicy CP.PHAR.257

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2016

Next Review DateMay 25, 2025

Key ActionPrior authorization required with documentation that the member meets the specified diagnosis, prescriber specialty, age, prior therapy failures/intolerances, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial approval duration

12 monthsContinued therapy duration

≥6 yrsMin age — Psoriasis

≥18 yrsMin age — AS/PsA

80 mg

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CurrentPeach State Health PlanPolicy CP.PHAR.257

Clinical Policy: Ixekizumab (Taltz)

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Sign up for Peach State Health Plan Policy CP.PHAR.257 alerts

Get alerted when Policy CP.PHAR.257 changes without checking for updates manually.

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Defines medical necessity criteria, prescriber requirements, dosing limits, and continuation rules for coverage of ixekizumab (Taltz) for Peach State Health Plan (Medicaid) members.

Policy Summary

PayerPeach State Health Plan

PolicyClinical Policy: Ixekizumab (Taltz)

Policy CodePolicy CP.PHAR.257

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2016

Next Review DateMay 25, 2025

Key ActionPrior authorization required with documentation that the member meets the specified diagnosis, prescriber specialty, age, prior therapy failures/intolerances, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial approval duration

12 monthsContinued therapy duration

≥6 yrsMin age — Psoriasis

≥18 yrsMin age — AS/PsA

80 mg

Maintenance dose (adult)

C9399, J3590HCPCS referenced

Coverage and Medical Necessity Criteria

Initial Therapy — Axial Spondyloarthritis

Covered when ALL of the following are met for this indication

Axial Spondyloarthritis (AS or nr-axSpA) initial criteria: 1. Diagnosis of ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA). 2. Prescribed by or in consultation with a rheumatologist. 3. Age ≥ 18 years. 4. Failure of at least TWO non-steroidal anti-inflammatory drugs (NSAIDs) at up to maximally indicated doses, each used for ≥ 4 weeks unless clinically significant adverse effects are experienced or all are contraindicated. 5. No combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors. 6. Dose does not exceed one of the following: a) For AS: 160 mg at week 0, followed by maintenance dose of 80 mg every 4 weeks; b) For nr-axSpA: 80 mg every 4 weeks.

Approval duration: 6 months

Initial Therapy — Plaque Psoriasis

Plaque Psoriasis (PsO) initial criteria: 1. Diagnosis of moderate-to-severe plaque psoriasis as evidenced by either: a) ≥ 3% total body surface area involvement; or b) involvement of hands, feet, scalp, face, or genital area. 2. Prescribed by or in consultation with a dermatologist or rheumatologist. 3. Age ≥ 6 years. 4. Member meets one of the following prior-therapy requirements: a) Failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses; b) Intolerance or contraindication to MTX and failure of a ≥ 3 consecutive month trial of cyclosporine or acitretin at up to maximally indicated doses unless clinically significant adverse effects or contraindications; c) Intolerance or contraindication to MTX, cyclosporine, and acitretin, and failure of phototherapy unless contraindicated or clinically significant adverse effects. 5. No combination use with bDMARDs or JAK inhibitors. 6. Dose does not exceed one of the following per age/weight: a) Adults: initial 160 mg at week 0 (two 80 mg injections), then 80 mg at weeks 2, 4, 6, 8, 10, and 12, followed by maintenance 80 mg every 4 weeks; b) Pediatric <25 kg: 40 mg at week 0, then 20 mg every 4 weeks; c) Pediatric 25–50 kg: 80 mg at week 0, then 40 mg every 4 weeks; d) Pediatric >50 kg: 160 mg at week 0 (two 80 mg injections), then 80 mg every 4 weeks.

Approval duration: 6 months

Initial Therapy — Psoriatic Arthritis

Psoriatic Arthritis (PsA) initial criteria: 1. Diagnosis of psoriatic arthritis (PsA). 2. Prescribed by or in consultation with a dermatologist or rheumatologist. 3. Age ≥ 18 years. 4. No combination use with bDMARDs or JAK inhibitors. 5. Dose does not exceed one of the following: a) PsA alone: 160 mg at week 0, followed by maintenance dose of 80 mg every 4 weeks; b) PsA with coexistent PsO: 160 mg at week 0, 80 mg at weeks 2, 4, 6, 8, 10, and 12, followed by maintenance 80 mg every 4 weeks.

Approval duration: 6 months

Continued Therapy

Continued therapy is covered when ALL of the following are met

Continued Therapy: 1. Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria, or continuity of care applies. 2. Member is responding positively to therapy. 3. Member does not have combination use with bDMARDs or JAK inhibitors. 4. If the request is for a dose increase, the new dose does not exceed 80 mg every 4 weeks.

Approval duration: 12 months

Other Indications

Other indications: 1. If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow either: a) the no coverage criteria policy for the relevant line of business (e.g., CP.PMN.255 for Medicaid) if the drug is on formulary/PDL; or b) the non-formulary policy (e.g., CP.PMN.16 for Medicaid) if not on formulary/PDL. 2. If the requested use is not specifically listed under Section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.PMN.53 for Medicaid).

Approval duration: 6 months

Dosing and administration (coverage-relevant)

Dosing regimens (by indication and weight) to be used when coverage is approved

Adult plaque psoriasis dosing: Initial: 160 mg subcutaneous (two 80 mg injections) at week 0; then 80 mg SC at weeks 2, 4, 6, 8, 10, and 12. Maintenance: 80 mg SC every 4 weeks.

Appendix D dosing table; chunk 18

Pediatric plaque psoriasis dosing (ages 6-17) by weight: >50 kg: starting 160 mg (two 80 mg injections) then 80 mg Q4W; 25–50 kg: 80 mg start then 40 mg Q4W; <25 kg: 40 mg start then 20 mg Q4W.

Appendix D pediatric dosing table; chunk 18

Other indications dosing summary: Psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA): dosing generally 80 mg SC every 4 weeks; initial/loading doses per Appendix D where specified.

Appendix D mentions these indications and 80 mg Q4W dosing; chunk 18

Coverage for uses of ixekizumab that are not FDA‑approved and are not specifically addressed in this policy is not authorized unless the request is supported by sufficient documentation of efficacy and safety in accordance with the Peach State off‑label use policy CP.PMN.53 or other applicable evidence of coverage documents. Requests for off‑label indications must include clinical rationale and supporting documentation to permit individual consideration.

The policy reiterates that combination use with another biologic disease‑modifying antirheumatic drug (bDMARD) or a Janus kinase inhibitor (JAKi) is not permitted; this prohibition was expressly carried forward from Section III into the initial and continued therapy criteria during the 2Q2022 policy update.

Use of ixekizumab in combination with other bDMARDs or potent immunosuppressants is explicitly not authorized / not medically necessary due to the risk of additive immunosuppression, neutropenia, and serious infections. Examples of agents/classes listed in the policy include tumor necrosis factor (TNF) antagonists, interleukin inhibitors (IL‑1, IL‑6, IL‑17, IL‑23, etc.), anti‑CD20 monoclonal antibodies, selective co‑stimulation modulators, integrin receptor antagonists, tyrosine kinase 2 inhibitors, sphingosine 1‑phosphate receptor modulators, and JAK inhibitors.

Initial Therapy Requirements by Indication

Initial Therapy — indication-specific requirements

Initial therapy — indication-specific requirements

Prescriber specialty and age requirements: Prescriptions must be written by or in consultation with the specified specialist: rheumatologist for axial spondyloarthritis; dermatologist or rheumatologist for plaque psoriasis and psoriatic arthritis. Minimum ages: PsO ≥ 6 years; AS and PsA ≥ 18 years.

Prior therapy requirements by indication: Axial spondyloarthritis: failure of at least TWO NSAIDs each used ≥ 4 weeks unless adverse effects or contraindicated. Plaque psoriasis: prior failure of systemic therapy per criteria (e.g., ≥3 months of methotrexate) or documented intolerance/contraindication with sequential failure of cyclosporine/acitretin or phototherapy as specified. Psoriatic arthritis: no mandated conventional DMARD trial specified in policy; see dosing and specialist requirements.

Prohibited combination therapy: Member must not be receiving combination therapy with other biological DMARDs or Janus kinase (JAK) inhibitors (see Section III).

Criteria for Continuing Therapy

Continued Therapy — continued therapy criteria

Continued therapy — applicable to all indications

Continued therapy (all indications): 1. Member is currently receiving medication via the benefit or previously met initial approval criteria (or continuity of care applies). 2. Member is responding positively to therapy. 3. Member does not have combination use with bDMARDs or JAK inhibitors. 4. Dose increase requests must not exceed 80 mg every 4 weeks.

Continuation — renewal requirements

Continuation / Renewal requirements: 1. For renewal, maintain dosing consistent with the approved schedule (typically 80 mg SC every 4 weeks for maintenance). 2. Member must continue to avoid prohibited combination therapy with other bDMARDs or JAK inhibitors. 3. Documentation of ongoing clinical response should be provided. 4. Prior authorization renewals follow plan-specific procedures and durations (continued therapy approvals generally 12 months).

Referenced in continued therapy and coding/revision notes; chunks 10 and 22

Required Prior Therapies and Alternatives

Step	Requirement	Provider actions
1
For plaque psoriasis: prior failure of systemic therapy — one of the following must be met
Document trial and duration (≥3 consecutive months for methotrexate; ≥3 months for cyclosporine or acitretin when MTX contraindicated/intolerant) with chart notes or other clinical documentation; include dosing and reason for failure/intolerance.

Step	Requirement	Provider actions
1
For axial spondyloarthritis (AS or nr-axSpA): failure of at least TWO NSAIDs each used at up to maximally indicated doses for ≥4 weeks unless adverse effects or contraindicated.
Document NSAID names, doses, dates, duration (≥4 weeks each) or provide clinical justification for intolerance/contraindication; ensure prescriber is rheumatologist or consult documented for initial request.

Phototherapy role	When allowed	Provider actions / notes
Alternative to systemic conventional DMARD
Allowed for plaque psoriasis when systemic conventional DMARD (eg, methotrexate, cyclosporine, acitretin) is contraindicated or clinically significant adverse effects are experienced
Document contraindication or adverse effects to systemic DMARD(s) and prior phototherapy trial and outcome when applicable; include dosing/product information as per Appendix D; note that HCPCS coding/PA requirements still apply and coding inclusion does not guarantee coverage.

Prior Authorization

Required prior systemic therapy for PsO; documentation, dosing, coding, and combination-use prohibitions

For plaque psoriasis, prior systemic therapy is required before authorizing ixekizumab: documented failure of a ≥3 consecutive month trial of methotrexate at up to maximally indicated doses, or documented intolerance/contraindication to methotrexate plus failure of a ≥3 month trial of cyclosporine or acitretin (unless adverse effects or contraindicated), or intolerance/contraindication to MTX, cyclosporine, and acitretin plus failure of phototherapy (unless contraindicated). Dosing must follow the policy’s adult and pediatric weight-band regimens when approved. Inclusion of HCPCS codes does not guarantee coverage and prior authorization with supporting documentation is required. Combination use with another biologic DMARD or a JAK inhibitor is prohibited and will preclude approval.

Required prior therapy (Plaque PsO): failure of ≥3 consecutive months of methotrexate at up to maximally indicated doses, OR intolerance/contraindication to MTX plus failure of ≥3 months of cyclosporine or acitretin, OR intolerance/contraindication to MTX, cyclosporine, and acitretin plus failure of phototherapy (unless contraindicated) [chunk 6].
Dosing and product info must be documented with the request: adult initial 160 mg at week 0 then 80 mg at weeks 2,4,6,8,10,12 and maintenance 80 mg every 4 weeks; pediatric weight-band dosing per policy (e.g., <25 kg start 40 mg then 20 mg Q4W; 25–50 kg start 80 mg then 40 mg Q4W; >50 kg start 160 mg then 80 mg Q4W) [chunk 6; chunk 18].

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorization with required supporting clinical documentation

Prior authorization is required and requests must include documentation that the member meets the specified diagnosis, prescriber specialty and age criteria, prior therapy failures/intolerances, absence of prohibited combination therapy, and dosing does not exceed policy limits.

Confirm diagnosis per indication-specific criteria (e.g., ≥3% BSA for PsO or AS/nr-axSpA diagnosis).
Prescriber is a dermatologist or rheumatologist (or consultation documented) as required by indication.
Provide prior therapy history and any intolerance/contraindication documentation.
Document proposed dosing and ensure it does not exceed the policy dose limits.

Billing Rule

HCPCS coding (C9399, J3590) and prior authorization

Billing and Code References

HCPCS Codes referencedHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologicals

BSA threshold for moderate-to-severe psoriasis

BSA thresholdAt least 3% total body surface area OR involvement of hands, feet, scalp, face, or genital area (areas that severely impact daily function)

Policy referenceAdded per 2019 AAD/NPF guidelines in 2Q2021 review

Approval duration contextUsed as part of initial Plaque Psoriasis criteria for 6-month initial approval

Dose Schedules and Quantity Limits

Ixekizumab (Taltz) — maintenance and regimen overview

Maintenance dose (typical)80 mg subcutaneous every 4 weeks

Adult plaque psoriasis initial regimen160 mg SC (two 80 mg injections) at week 0; then 80 mg SC at weeks 2, 4, 6, 8, 10, 12; maintenance 80 mg Q4W

PsA / AS dosing summaryFor PsA and AS indications dosing is generally 80 mg SC every 4 weeks (with indication-specific initial 160 mg where noted)

Ixekizumab (Taltz) — dosing schedule and pediatric weight bands

Adult initial dose (Plaque PsO)160 mg SC (two 80 mg injections) at week 0, then 80 mg SC at weeks 2,4,6,8,10,12; maintenance 80 mg Q4W

Pediatric dosing — >50 kgStarting 160 mg (two 80 mg injections) at week 0; then 80 mg every 4 weeks

Abbreviations and Product Availability

Abbreviations

ASankylosing spondylitis

nr-axSpAnon-radiographic axial spondyloarthritis

PsApsoriatic arthritis

PsOplaque psoriasis

IL-17Ainterleukin-17A

MTXmethotrexate

JAKiJanus kinase inhibitors

Administration Setting

Note

Home administration / site‑of‑care determination

Self-administered subcutaneous injection presentations are available; site‑of‑care (including home administration) should be determined per plan and provider.

Available presentations support self‑administration (autoinjector and prefilled syringes).
Determine site‑of‑care per plan/provider policies.

Clinical Background

Ixekizumab (Taltz) is a monoclonal antibody that functions as an interleukin‑17A (IL‑17A) antagonist and is indicated for treatment of moderate‑to‑severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non‑radiographic axial spondyloarthritis where appropriate. The policy aligns age and dosing criteria to FDA‑approved indications and Appendix dosing tables: for adult plaque psoriasis the recommended induction is 160 mg at week 0 (two 80 mg injections) followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12 with maintenance of 80 mg every 4 weeks, with pediatric weight‑banded dosing and self‑administered prefilled syringe/auto‑injector presentations noted in the product information.

Policy Revision History

2025-02-28references_updatedLatest

Prescribing information and guideline citations updated through 2025, including Taltz Prescribing Information (August 2024) and major guideline references (AAD-NPF 2019; EULAR 2019; ACR/NPF 2018; ACR/SpA 2019).

Policy Summary

PayerPeach State Health Plan

PolicyClinical Policy: Ixekizumab (Taltz)

Policy CodePolicy CP.PHAR.257

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2016

Next Review DateMay 25, 2025

Key ActionPrior authorization required with documentation that the member meets the specified diagnosis, prescriber specialty, age, prior therapy failures/intolerances, and dosing limits.

SourceLink

On This Page

Approval duration and documentation: Initial approvals are generally for 6 months; providers must submit documentation (e.g., office notes, labs) supporting diagnosis, prior therapy trials/intolerances, and dosing. Prior authorization is required.

Initial therapy dosing

Initial therapy dosing — per indication and pediatric weight bands

Adult initial dosing (plaque psoriasis): 160 mg SC (two 80 mg injections) at week 0 as the initial dose for adults with plaque psoriasis.

Pediatric initial dosing by weight: >50 kg: 160 mg initial (two 80 mg) then 80 mg Q4W; 25–50 kg: 80 mg initial then 40 mg Q4W; <25 kg: 40 mg initial then 20 mg Q4W.

Initial dosing for AS, nr-axSpA, and PsA: Where specified: AS and nr-axSpA and PsA use initial/loading and maintenance dosing per Appendix D; maintenance dosing generally 80 mg SC every 4 weeks with initial 160 mg where indicated.

HCPCS coding: providers should reference policy-listed codes (e.g., C9399, J3590) but note that listing of codes does not guarantee coverage—follow up-to-date professional coding guidance when submitting claims [chunks 21, 22].

Prior authorization: submit supporting documentation (office/chart notes, labs, prior therapy records) showing diagnoses, prescriber specialty, age, prior therapy trials/intolerance, avoidance of disallowed combination therapy, and adherence to dosing limits; lack of documentation will result in denial [chunks 3, 12].

Combination therapy prohibition: use with another biologic DMARD or a JAK inhibitor is not authorized and is a trigger for denial; do not request coverage for concurrent use with these agents [chunks 12, 13, 22].

When billing for unclassified drugs/biologicals reference HCPCS codes C9399 or J3590 as applicable; inclusion of these codes in the policy indicates they are referenced and prior authorization requirements apply.

HCPCS C9399 — Unclassified drugs or biologicals.
HCPCS J3590 — Unclassified biologicals.
Follow plan and professional coding guidance when submitting claims.

Note

Prohibited combination therapy; phototherapy allowed as alternative

Do not combine ixekizumab with another biologic DMARD or a JAK inhibitor; phototherapy is allowed as an alternative to systemic conventional DMARDs for psoriasis when systemic DMARDs are contraindicated or not tolerated.

Combination use with bDMARDs or JAK inhibitors is prohibited per Section III and reiterated in policy updates.
Phototherapy may be used as an alternative when systemic conventional DMARDs are contraindicated or cause clinically significant adverse effects.

Documentation Required

Required supporting documentation for PA requests

Submit office chart notes, laboratory results, and other clinical information that document the member meets all approval criteria to support prior authorization approval.

Include documented diagnosis, prior treatment trials and durations, intolerance/contraindication details, and prescriber specialty/consultation notes.
Provide dosing plan and any relevant pediatric weight-based calculations if applicable.

Denial Risk

Triggers that will result in coverage denial

Requests may be denied if documentation is lacking that the member met all approval criteria, if the requested use is a non‑FDA indication without off‑label justification per policy, or if the member is receiving prohibited combination therapy.

Lack of documentation of prior therapy trials, diagnosis, prescriber specialty, age, or dosing limits can trigger denial.
Non‑FDA approved indications require off‑label policy support (CP.PMN.53) or evidence of coverage documents.
Combination use with other bDMARDs or JAK inhibitors is a basis for non‑authorization.

Note

Coding references do not guarantee coverage

Inclusion of codes in this policy is for informational purposes only and does not guarantee coverage; providers must reference current professional coding guidance prior to claim submission.

Codes referenced are informational; verify correct code selection and payer billing requirements before claim submission.

Documentation Required

Document dosing regimen and product strength

Document the requested dosing regimen and product strength (adult and pediatric dosing tables; available single‑dose autoinjector and prefilled syringe strengths) when requesting coverage.

Adult plaque psoriasis initial: 160 mg (two 80 mg injections) at week 0; maintenance 80 mg SC every 4 weeks.
Pediatric weight-based starting doses and Q4W maintenance per Appendix D.
Product presentations: 80 mg/mL autoinjector; syringes 20 mg/0.25 mL, 40 mg/0.5 mL, 80 mg/mL.

Pediatric dosing — 25–50 kgStarting 80 mg at week 0; then 40 mg every 4 weeks

Pediatric dosing — <25 kgStarting 40 mg at week 0; then 20 mg every 4 weeks

Product availability — presentations and strengths

Autoinjector strengthSingle-dose prefilled autoinjector: 80 mg/mL

Prefilled syringe strengthsSingle-dose prefilled syringes: 20 mg/0.25 mL, 40 mg/0.5 mL, 80 mg/mL

AdministrationSelf-administered subcutaneous injection presentations available