CurrentMass General Brigham Health PlanPolicy N/A

Taltz (ixekizumab) — Coverage Criteria (Pharmacy Benefit)

Defines prior authorization requirements, indications, and renewal criteria for Taltz (ixekizumab) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTaltz (ixekizumab) — Coverage Criteria (Pharmacy Benefit)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit medical records demonstrating current treatment or clinical improvement for initial or reauthorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial/Exchangeplan applicability

Prior Authorizationprogram type

24 monthsapproval duration

1/28dquantity limit

Specialty pharmacydispensing

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Initial Therapy — Moderate to Severe Plaque Psoriasis

Covered when ALL of the following are met for moderate-to-severe plaque psoriasis:

Plaque psoriasis initial criteria: 1) Diagnosis of moderate to severe plaque psoriasis; 2) At least 3% of body surface area (BSA) affected OR involvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); 3) The member meets ONE of the following: (a) Minimum 4-week trial with failure, intolerance, or contraindication to ONE topical therapy from the following list: corticosteroids (e.g., betamethasone, clobetasol), vitamin D analogs (e.g., calcitriol, calcipotriene), tazarotene, calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, or coal tar; OR (b) Severe psoriasis that warrants a biologic DMARD as first-line therapy.BSA >= 3% or crucial body area involvement

Topical therapies list is enumerated in policy

Initial Therapy — Psoriatic Arthritis

Covered when ALL of the following are met for active psoriatic arthritis (PsA):

Psoriatic arthritis initial criteria: 1) Diagnosis of active psoriatic arthritis; 2) The member has ONE of the following clinical manifestations: actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin and/or nail involvement.none

Choice of clinical manifestations meets requirement

Initial Therapy — Ankylosing Spondylitis

Covered when ALL of the following are met for active ankylosing spondylitis:

Ankylosing spondylitis initial criteria: 1) Diagnosis of active ankylosing spondylitis; 2) Minimum duration 1-month trial and failure, intolerance, or contraindication to at least two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses.1-month NSAID trials x2

NSAIDs examples: ibuprofen, naproxen

Initial Therapy — Non-radiographic Axial Spondyloarthritis

Covered when ALL of the following are met for non-radiographic axial spondyloarthritis (nr-axSpA):

nr-axSpA initial criteria: 1) Diagnosis of active non-radiographic axial spondyloarthritis; 2) Objective signs of inflammation (e.g., elevated CRP above the upper limit of normal and/or sacroiliitis on MRI); 3) Minimum duration 1-month trial and failure, intolerance, or contraindication to at least two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses.objective inflammation required

MRI or CRP to document inflammation

Continuation Therapy

Reauthorization (Continuation of Therapy):

Reauthorization criteria: Submission of medical records (e.g., chart notes) demonstrating improvement in the member's condition, evidenced by low disease activity or improvement in signs and symptoms of the condition.clinical improvement/low disease activity

Reauthorization approvals granted for 24 months

Prior authorization is required for Taltz (ixekizumab) under the pharmacy benefit for Commercial/Exchange members, and prescriptions must be dispensed via specialty pharmacy. Initial approvals and reauthorizations are granted for 24 months. A quantity limit applies to autoinjector/prefilled syringe formulations: 1 injection per 28 days.

Requests that do not meet the diagnosis-specific criteria outlined in the policy will be considered not medically necessary. Examples include insufficient documented disease extent for plaque psoriasis (less than 3% BSA and no involvement of crucial body areas) or lack of required prior therapy trials (e.g., absence of a documented minimum 4-week topical trial for plaque psoriasis or missing evidence of at least two separate 1-month NSAID trials for ankylosing spondylitis or nr-axSpA).

For nr-axSpA specifically, absence of documented objective signs of inflammation (for example, elevated CRP or sacroiliitis on MRI) is a reason to deny coverage when those findings are required by the criteria.

When required diagnostic findings or trial documentation are missing, include relevant medical records or chart notes (see documentation requirements) to avoid denial.

Authorization Steps, Required Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization and Specialty Fill

Prior authorization is required for Taltz (ixekizumab) under the pharmacy benefit. This product is designated as a specialty medication and must be dispensed through a contracted specialty pharmacy.

Benefit: Pharmacy benefit
Specialty fill required: Dispense at contracted specialty pharmacy
Contact: Pharmacy Benefit Phone 800-711-4555; Fax 844-403-1029

Step Therapy

Diagnosis‑Specific Trial Requirements

Authorization requests must demonstrate that the member meets the diagnosis-specific therapeutic trial requirements for the requested indication. For plaque psoriasis, documentation must show diagnosis of moderate to severe disease (≥3% BSA or involvement of crucial body areas) and either a ≥4-week trial and failure/intolerance/contraindication to at least one listed topical therapy OR severe disease warranting biologic as first-line. For active psoriatic arthritis, documentation must show diagnosis and presence of active inflammatory features (e.g., inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail disease). For ankylosing spondylitis and non-radiographic axial spondyloarthritis, documentation must show diagnosis, objective signs as required (for nr-axSpA), and a ≥1 month trial and failure/intolerance/contraindication to at least two different NSAIDs at maximally tolerated doses.

Plaque psoriasis: ≥3% BSA OR crucial body area involvement; trial ≥4 weeks of one topical agent unless severe disease
Psoriatic arthritis: evidence of active disease (inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement)
Ankylosing spondylitis / nr-axSpA: diagnosis plus NSAID trial failure (≥1 month trials of two different NSAIDs). For nr-axSpA, objective inflammation required (e.g., elevated CRP and/or MRI sacroiliitis)

Documentation Required

Required Medical Records and Documentation to Avoid Denial

To avoid denial, submit complete medical records and chart notes as part of the initial authorization and reauthorization requests. For members new to the plan (coverage effective date ≤ 90 days), include documentation that the member is currently receiving the requested drug (exclude samples or manufacturer patient assistance program supplies). For continuation of therapy, submit chart notes demonstrating clinical improvement or low disease activity (objective or provider-documented improvement in signs/symptoms). Failure to provide the requested medical records or supporting documentation may result in denial of the request.

New-to-plan members (≤90 days): medical records showing current use of the requested drug (exclude samples/PAP)
Reauthorization: chart notes showing improvement or low disease activity
Risk: Missing medical records/chart notes may lead to denial

Key Definitions and Diagnostic Criteria

inv-15: Moderate-to-severe plaque psoriasis — definition including >=3% BSA or involvement of crucial body areas

Definition (BSA)>= 3% of body surface area affected

Crucial body area involvementInvolvement of hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas qualifies as moderate-to-severe

Clinical implicationMeets criteria for candidates for systemic therapy or phototherapy when combined with diagnosis of moderate-to-severe plaque psoriasis

inv-16: Objective signs of inflammation (nr-axSpA) — elevated CRP and/or sacroiliitis on MRI without definitive radiographic structural damage

Objective inflammation criteriaElevated C-reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on MRI

Radiographic requirementFindings may be present on MRI without definitive radiographic structural damage of the sacroiliac joints

ApplicationRequired to qualify for treatment of non-radiographic axial spondyloarthritis (nr-axSpA)

Background

Ixekizumab (Taltz) is a humanized interleukin-17A (IL-17A) antagonist indicated for inflammatory conditions including moderate-to-severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis, and active non-radiographic axial spondyloarthritis with objective signs of inflammation. The policy separates coverage criteria by diagnosis and requires documentation of prior therapy trials for most indications (for example, a minimum 4-week topical trial for plaque psoriasis or at least two separate 1-month NSAID trials for axial spondyloarthritis) before authorization, unless severe disease meets biologic first-line criteria.

Initial approvals and reauthorizations under this policy are granted for 24 months, and dispensing is through specialty pharmacy with a quantity limit of 1 injection per 28 days for autoinjector/prefilled syringe formulations.

OpenPayer

Taltz (ixekizumab) — Coverage Criteria (Pharmacy Benefit)

Coverage and Authorization Criteria

Clinical Measures & Coding-related Thresholds

Authorization Steps, Required Documentation, and Provider Responsibilities

Key Definitions and Diagnostic Criteria

Background