CurrentCignaPolicy N/A

Inflammatory Conditions - Taltz (ixekizumab) Prior Authorization Policy

Defines Cigna's prior authorization criteria, approvals, and non-covered uses for Taltz (ixekizumab) for inflammatory conditions including ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis; applies to prescriptions under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Taltz (ixekizumab) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review DateJun 4, 2025

Key ActionObtain prior authorization with documentation of indication, prescriber specialty or consult, and required objective findings or prior therapy as specified for the indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4FDA‑approved indications covered

3-6 moInitial approval durations

1 yrContinuation approval duration

Concurrent biologicExplicitly not covered

Taltz (ixekizumab) Coverage Criteria

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Ankylosing Spondylitis

Ankylosing Spondylitis — Approve when ONE of the following is met

Ankylosing Spondylitis: Initial or Current Therapy: A) Initial Therapy: Approve for 6 months if BOTH i and ii are met; i. Patient is > 18 years of age; AND ii. The medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Taltz: Approve for 1 year if BOTH i and ii are met; i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following (a or b): a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Taltz). Note: Examples of objective measures include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQS, and/or serum markers (e.g., CRP, ESR). OR b) Compared with baseline (prior to initiating Taltz), patient experienced an improvement in at least one symptom, such as decreased pain or stiffness, or improvement in function or activities of daily living.

Non-Radiographic Axial Spondyloarthritis

Non-Radiographic Axial Spondyloarthritis — Approve when ONE of the following is met

Non-Radiographic Axial Spondyloarthritis: Initial or Current Therapy: A) Initial Therapy: Approve for 6 months if ALL of i, ii, and iii are met; i. Patient is > 18 years of age; AND ii. Patient has objective signs of inflammation, defined as at least ONE of the following: a) C-reactive protein elevated beyond the upper limit of normal for the reporting laboratory; OR b) Sacroiliitis reported on magnetic resonance imaging; AND iii. The medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Taltz: Approve for 1 year if BOTH i and ii are met; i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following (a or b): a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Taltz) (examples include ASDAS, BASDAI, serum markers, etc.); OR b) Compared with baseline, patient experienced an improvement in at least one symptom, such as decreased pain or stiffness, or improvement in function or activities of daily living.

Plaque Psoriasis

Plaque Psoriasis — Approve when ONE of the following is met

Plaque Psoriasis: Initial or Current Therapy: A) Initial Therapy: Approve for 3 months if ALL of i, ii, and iii are met; i. Patient is ≥ 6 years of age; AND ii. Patient meets ONE of the following: a) Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples include methotrexate, cyclosporine, or acitretin). A 3-month trial of PUVA also counts. An exception to the requirement for a trial of one traditional systemic agent can be made if the patient has already had a 3-month trial or previous intolerance to at least one biologic other than the requested drug. A biosimilar of the requested biologic does not count; OR b) Patient has a contraindication to methotrexate as determined by the prescriber; AND iii. The medication is prescribed by or in consultation with a dermatologist. OR B) Patient is Currently Receiving Taltz: Approve for 1 year if ALL of i, ii, and iii are met; i. Patient has been established on therapy for at least 3 months; AND ii. Patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of the following: estimated body surface area, erythema, induration/thickness, and/or scale of areas affected by psoriasis; AND iii. Compared with baseline, patient experienced an improvement in at least one symptom, such as decreased pain, itching, and/or burning.

Psoriatic Arthritis

Psoriatic Arthritis — Approve when ONE of the following is met

Psoriatic Arthritis: Initial or Current Therapy: A) Initial Therapy: Approve for 6 months if BOTH i and ii are met; i. Patient is > 18 years of age; AND ii. The medication is prescribed by or in consultation with a rheumatologist or a dermatologist. OR B) Patient is Currently Receiving Taltz: Approve for 1 year if BOTH i and ii are met; i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following (a or b): a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Taltz). Note: Examples of standardized measures of disease activity include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC enthesitis score, Leeds Dactylitis Instrument Score, MDA, PsAID-12, and/or serum markers (e.g., CRP, ESR). OR b) Compared with baseline, patient experienced an improvement in at least one symptom, such as less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths.

Requests for concurrent administration of Taltz with another biologic agent or a targeted synthetic oral small molecule for an inflammatory condition are not covered. The policy states that combination therapy is generally not recommended because of a potentially higher rate of adverse events and a lack of controlled clinical data showing additive efficacy. Methotrexate is an exception and may be used in combination with Taltz where clinically appropriate.

Use of Taltz for inflammatory bowel disease (Crohn's disease or ulcerative colitis) is not covered. The policy notes that exacerbations of inflammatory bowel disease, in some cases serious, occurred in clinical trials with patients treated with Taltz, and therefore Taltz is excluded for these indications.

The appendix is provided as a reference list of agents, formulations, mechanisms, and commonly used abbreviations and is not an exhaustive list of coverage exclusions. For complete coverage determinations providers should refer to the product prescribing information and the main policy text; the appendix itself does not replace the main policy or prescribing information when determining coverage.

Taltz is considered not medically necessary for any indications beyond those specifically listed in the policy. This includes use in combination with another biologic or a targeted synthetic small molecule for inflammatory conditions; such combination therapy will be denied as not medically necessary under the policy.

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Taltz. All approvals are for the durations specified in the policy. Initial approvals require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., rheumatologist for ankylosing spondylitis, dermatologist for plaque psoriasis). When approval durations are stated in months, 1 month = 30 days.

Prior authorization required for initial and continuation requests
Initial approval requires prescription by or consultation with an appropriate specialist

Note

Appendix Reference for Prior Authorization

The Appendix lists mapped agents, formulations (SC vs IV), mechanisms of action, and indications to assist providers in identifying comparable biologics or targeted therapies. Providers should refer to the main policy and the full prescribing information for agent-specific details and indications.

Appendix maps drugs to formulation and indications (e.g., Taltz: ixekizumab SC injection = Inhibition of IL-17A; lists SC vs IV formulations where applicable)
Appendix is a reference for examples and is not a substitute for prescribing information

Note

None Stated in These Appendix Pages

The appendix pages provided are intended as a drug/indication mapping reference only and do not specify additional provider actions or supplemental prior authorization steps beyond those in the main policy.

Appendix provides mapping of agents, formulations, mechanisms, and indications only
No additional provider actions are stated in these appendix pages

Documentation Required

Documentation for Continuation Approvals

For continuation (renewal) approvals, documentation must show the patient has been established on therapy for the required minimum duration and demonstrate clinical benefit compared with baseline. Examples of acceptable documentation include objective disease activity measures or clinician-documented symptomatic improvement as specified by indication.

Continuation approvals require the patient to have been established on therapy for the policy-specified minimum duration (e.g., ≥6 months for AS, ≥3 months for plaque psoriasis where noted)
Documentation of benefit may include objective measures (e.g., BASDAI, ASDAS, DAPSA, PASI/body surface area, CRP/ESR) or documented symptom improvement from baseline

Note

Appendix Entries Reference Formulation

Appendix entries explicitly reference formulation (SC vs IV) and list indications for each agent; providers should use the Appendix to identify formulation-specific indications but rely on the main policy for prior authorization requirements and on prescribing information for dosing and administration details.

Appendix notes formulation (SC vs IV) alongside indications for each agent (e.g., Taltz recorded as SC injection with listed indications)
Refer to full prescribing information and main policy for dosing/administration and PA criteria

Step Therapy

No Step Therapy Rules Specified in Appendix

No step therapy rules are specified in the appendix pages provided. Any step-therapy or trial requirements are defined in the main policy criteria (for example, plaque psoriasis initial therapy requires a trial of at least one traditional systemic agent unless otherwise noted).

Appendix does not define step therapy rules
Main policy contains any step requirements (e.g., trial of a traditional systemic agent for plaque psoriasis)

Key Terms and Abbreviations

inv-20: Taltz (ixekizumab) — IL-17A antagonist indicated for AS, nr-axSpA, plaque psoriasis, and psoriatic arthritis

DrugTaltz (ixekizumab)

MechanismInterleukin (IL)-17A antagonist

FDA‑approved indicationsAnkylosing spondylitis (adults); Non-radiographic axial spondyloarthritis (adults, with objective signs of inflammation); Plaque psoriasis (patients ≥6 years with moderate to severe disease who are candidates for systemic therapy or phototherapy); Psoriatic arthritis (adults)

Typical prescriber specialtyRheumatologist for AS/nr-axSpA/PsA; Dermatologist for plaque psoriasis

Formulation noteReferenced as subcutaneous injection in appendix and prescribing information

inv-21: Objective signs of inflammation for nr-axSpA — elevated CRP and/or sacroiliitis on MRI

DefinitionObjective signs of inflammation for nr-axSpA are defined as elevated C-reactive protein and/or sacroiliitis on magnetic resonance imaging (MRI)

CRP thresholdElevated C-reactive protein above the laboratory upper limit of normal (as used in pivotal trials)

Imaging criterionSacroiliitis documented on MRI

Source contextRequirement mirrors pivotal trial enrollment criteria for nr-axSpA

inv-22: Abbreviations list used in appendix (SC, IV, RA, JIA, etc.)

SCSubcutaneous

IVIntravenous

ASAnkylosing spondylitis

nr-axSpANon-radiographic axial spondyloarthritis

PsOPlaque psoriasis

PsAPsoriatic arthritis

RA / JIA / PJIA / SJIARheumatoid arthritis; Juvenile idiopathic arthritis; Polyarticular JIA; Systemic JIA

OpenPayer

Inflammatory Conditions - Taltz (ixekizumab) Prior Authorization Policy

Taltz (ixekizumab) Coverage Criteria

Prior Authorization, Documentation, and Billing Guidance

Key Terms and Abbreviations

Clinical and Policy Background