ModifiedmhnPolicy CP.PHAR.375

Clinical Policy: Brodalumab (Siliq)

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This policy governs medical necessity criteria, dosing, and coverage limitations for brodalumab (Siliq) for treatment of moderate-to-severe plaque psoriasis in adult Medicaid members and requirements providers must submit for authorization.

Policy Summary

Payermhn

PolicyClinical Policy: Brodalumab (Siliq)

Policy CodePolicy CP.PHAR.375

Change TypeMaterial updates to contraindications, step-therapy alternatives, and approval durations

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating moderate-to-severe plaque psoriasis and required prior therapy trials or evidence of biologic failure.

SourceLink

POLICY UPDATE CHANGES

Added hypersensitivity to brodalumab or to any of the excipients as a contraindication per prescriber information.

Added requirement to use Taltz and preferred adalimumab products prior to brodalumab for certain criteria; added these alternatives to Appendix B.

Extended initial approval durations to 12 months for chronic conditions and allowed bypass of conventional therapies if a member has failed a biologic agent.

Updated Section III.B to include several newly listed biologic agents and biosimilars (examples include Bimzelx, Sotyktu, Simlandi, Stelara biosimilars).

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ModifiedmhnPolicy CP.PHAR.375

Clinical Policy: Brodalumab (Siliq)

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Policy Summary

Payermhn

PolicyClinical Policy: Brodalumab (Siliq)

Policy CodePolicy CP.PHAR.375

Change TypeMaterial updates to contraindications, step-therapy alternatives, and approval durations

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating moderate-to-severe plaque psoriasis and required prior therapy trials or evidence of biologic failure.

SourceLink

POLICY UPDATE CHANGES

Added hypersensitivity to brodalumab or to any of the excipients as a contraindication per prescriber information.

Added requirement to use Taltz and preferred adalimumab products prior to brodalumab for certain criteria; added these alternatives to Appendix B.

Extended initial approval durations to 12 months for chronic conditions and allowed bypass of conventional therapies if a member has failed a biologic agent.

Updated Section III.B to include several newly listed biologic agents and biosimilars (examples include Bimzelx, Sotyktu, Simlandi, Stelara biosimilars).

12 monthsapproval duration for initial authorization

≥ 3% BSAdiagnostic threshold

210 mgmaintenance dose

18+minimum age

NCapplicable state

Coverage Criteria for Brodalumab (Siliq)

Initial Therapy and Continuation Therapy

Covered when ALL of the following are met:

Initial Plaque Psoriasis Criteria: 1. Diagnosis of moderate-to-severe plaque psoriasis as evidenced by either: a. ≥ 3% total body surface area (BSA) 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 ≥ 18 years; 4. Member meets ONE of the following unless the member has previously failed a biologic agent for PsO: a. Failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses; b. Intolerance or contraindication to MTX (see Appendix D) and failure of a ≥ 3 consecutive month trial of cyclosporine or acitretin at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; c. Intolerance or contraindication to MTX, cyclosporine, and acitretin and failure of phototherapy, unless contraindicated or clinically significant adverse effects are experienced; 5. Member meets ONE of the following, unless clinically significant adverse effects are experienced or all are contraindicated: a. Failure of a ≥ 3 consecutive month trial of one adalimumab product (examples and preferred products listed in Appendix B), OR b. History of failure of two TNF blockers; 6. Failure of a ≥ 3 consecutive month trial of ixekizumab (Taltz), unless contraindicated or clinically significant adverse effects are experienced; 7. Failure of a ≥ 3 consecutive month trial of one ustekinumab product, unless contraindicated or clinically significant adverse effects are experienced; 8. No combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors; 9. Prescribed dose does not exceed 210 mg at weeks 0, 1, and 2, followed by maintenance dosing of 210 mg every 2 weeks. Approval duration: 12 months.>= 3% BSA or involvement of special sites

See Appendix D for MTX contraindications and Section III for not authorized uses.

Continued Therapy (Plaque Psoriasis): 1. Member is currently receiving brodalumab through the Centene benefit or previously met the initial approval criteria or qualifies under continuity of care per state rules; 2. Member is responding positively to therapy (clinical improvement documented in chart notes); 3. No combination use with bDMARDs or JAK inhibitors; 4. If a dose increase is requested, the new dose must not exceed 210 mg every 2 weeks.

Approval duration for continued therapy follows policy terms (typically up to 12 months per initial authorization extension).

Initial Therapy / Coverage summary — includes clinical criteria, prior biologic use requirements, contraindications, and preference for specified alternatives

Policy coverage is governed by specified clinical criteria, prior biologic use requirements, contraindications, and preference for specified alternatives.

Initial coverage pathway (summary): Member must meet AAD/NPF-aligned criteria for moderate-to-severe plaque psoriasis (e.g., ≥3% BSA or involvement of functionally significant areas) and satisfy the step-therapy requirements and prior biologic use specified by this policy; preferred biologics (including Taltz and specified preferred adalimumab products, and one preferred Stelara biosimilar) are required before brodalumab per recent updates unless bypass is allowed for prior biologic failure. Contraindication includes hypersensitivity to brodalumab or any excipients. Combination use with other bDMARDs or JAK inhibitors is not authorized.see BSA threshold (>=3% or special sites)

Full detailed criteria are in the Initial Approval Criteria section; prior authorization is governed by this clinical policy and approval durations for chronic conditions have been extended to 12 months.

Non‑FDA approved indications for brodalumab are not authorized under this clinical policy unless the use is supported by the Health Plans off‑label use policy (CP.PMN.53) or other applicable evidence of coverage documents. Combination therapy with other biologic disease‑modifying antirheumatic drugs (bDMARDs) or other potent immunosuppressants is expressly not authorized in this policy; examples include but are not limited to tumor necrosis factor antagonists, interleukin agents, Janus kinase inhibitors (JAKi), anti‑CD20 antibodies, co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, and S1P modulators. Treatment of Crohns disease is also not authorized.

Hypersensitivity to brodalumab or to any of its excipients is listed as a contraindication and therefore excludes coverage per the prescriber information.

Combination use of brodalumab with another biologic DMARD or a JAK inhibitor is not authorized due to the risk of additive immunosuppression, increased risk of neutropenia, and higher risk of serious infections. This policy therefore requires that brodalumab not be used concurrently with the classes of agents listed in Section III, and providers should follow coding guidance when submitting claims.

Requests for concurrent therapy with brodalumab and another biologic DMARD or a JAK inhibitor will be considered not medically necessary and are grounds for denial under this policy.

Coding and Billing References

Referenced billing codesHCPCS

J3590	Unclassified drugs or biologicals
C9399	Unclassified drugs or biologicals

Informational HCPCS codesHCPCS

J3590	Unclassified drugs or biologicals
C9399	Unclassified drugs or biologicals

Body Surface Area (BSA) — threshold value

BSA threshold>= 3% total body surface area

Source guidance2019 AAD/NPF criteria referenced in policy (at least 3% BSA)

Use contextRequired to meet 'moderate-to-severe' diagnosis for initial approval

Body Surface Area (BSA) for moderate-to-severe psoriasis per guidance

Moderate-to-severe PsO BSA>= 3% BSA (or involvement of hands, feet, scalp, face, or genital area)

Policy reference2Q 2021 review added criteria per 2019 AAD/NPF guidelines specifying at least 3% BSA or functionally significant areas

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization and Coding

Prior authorization is required for brodalumab (Siliq) and related products. Providers should submit PA requests per the Health Plan's prior authorization process. Note that prior authorization may also be required for comparator products referenced in the criteria (e.g., Taltz, adalimumab products, ustekinumab).

Prior authorization required for brodalumab and may be required for listed comparators (Taltz, adalimumab products, ustekinumab).
Inclusion of HCPCS/unclassified drug codes (e.g., J3590, C9399) in this policy is informational only and does not guarantee coverage; validate coding before claim submission.

Prior Authorization

Prior Authorization Requirements

Initial approvals are granted for 12 months for chronic plaque psoriasis when all criteria are met. Prior authorization requirements include verification that the member meets the clinical criteria (see Initial Approval Criteria) and that step-therapy or therapeutic-alternative requirements have been satisfied or appropriately bypassed per policy.

Background on Brodalumab (Siliq)

Brodalumab (Siliq) is an interleukin‑17 receptor A antagonist indicated for adult patients with moderate‑to‑severe plaque psoriasis who are candidates for systemic therapy or phototherapy and who have failed other systemic therapies. The policy aligns with AAD/NPF guidance requiring at least 3% body surface area (BSA) involvement or involvement of functionally or cosmetically significant areas (hands, feet, scalp, face, genital area) to define moderate‑to‑severe disease, and it specifies dosing and prior‑therapy requirements for initial and continued coverage.

Abbreviations and Definitions

Abbreviations

PsOplaque psoriasis

MTXmethotrexate

JAKiJanus kinase inhibitors

IL-17Ainterleukin 17A

moderate-to-severe psoriasis definition per 2019 AAD/NPF guidance (>= 3% BSA or special site involvement)

Definition (numeric threshold)>= 3% total body surface area

Alternate (special sites)Involvement of hands, feet, scalp, face, or genital area qualifies as moderate-to-severe

Policy Summary

Payermhn

PolicyClinical Policy: Brodalumab (Siliq)

Policy CodePolicy CP.PHAR.375

Change TypeMaterial updates to contraindications, step-therapy alternatives, and approval durations

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating moderate-to-severe plaque psoriasis and required prior therapy trials or evidence of biologic failure.

SourceLink

On This Page

ApplicationUsed to determine eligibility for brodalumab under initial approval criteria

Approval duration: 12 months for chronic conditions.

Bypass of conventional therapy permitted if member has previously failed a biologic; otherwise step therapy applies.

Denial Risk

Denial Risk — When Requests May Be Denied

Requests may be denied when the submitted documentation does not demonstrate a diagnosis of moderate-to-severe plaque psoriasis as defined by this policy, when the indication is non–FDA approved without appropriate off-label justification, or when combination use with prohibited therapies is requested.

Denial risk if diagnosis does not meet moderate-to-severe psoriasis criteria (≥3% BSA or involvement of hands/feet/scalp/face/genital area).
Denial risk for non-FDA indications absent sufficient off-label documentation per CP.PMN.53 or evidence of coverage.
Denial risk for combination use with bDMARDs, JAK inhibitors, or other prohibited immunosuppressants.

Documentation Required

Required Documentation

Providers must submit supporting documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results, prior medication trials (dates, doses, and responses), phototherapy records where applicable, and consultation notes if treatment is initiated by or in consultation with a dermatologist or rheumatologist.

Submit office chart notes that document BSA or involvement of special areas and disease severity.
Provide records of prior trials (drug name, dose, duration, and reason for discontinuation) for conventional agents and biologics.
Include lab results or other clinical information as applicable to support contraindications or adverse reactions.

Documentation Required

Supportive Documentation and Policy Conformance

Follow applicable Health Plan coverage documents and state and federal requirements when assembling supportive documentation. Documentation must support medical necessity and meet the Health Plan's administrative requirements for PA decisions.

Adhere to Evidence of Coverage, certificate of coverage, and applicable state Medicaid rules when they supersede this clinical policy.
Ensure documentation supports medical necessity consistent with generally accepted standards and the Health Plan's administrative policies.
Providers are responsible for maintaining and providing records as requested for review or audit.

Step Therapy

Required Prior Trials (Step Therapy)

Step therapy requires failure of conventional systemic agents before brodalumab is approved unless the member has failed a biologic (in which case conventional therapies may be bypassed). Specifically, the policy requires trials of methotrexate and cyclosporine or acitretin (or phototherapy when indicated) as outlined in Initial Approval Criteria.

Failure of ≥3 months of methotrexate at up to maximally indicated doses unless intolerant/contraindicated.
If MTX not tolerated/contraindicated, failure of ≥3 months of cyclosporine or acitretin unless contraindicated.
If intolerant/contraindicated to the above, failure of phototherapy is required unless contraindicated.

Step Therapy

Required Therapeutic Alternatives

Therapeutic-alternative requirements mandate use of preferred biologic alternatives prior to brodalumab per recent updates. The policy requires failure of or intolerance to preferred agents including Taltz and specified preferred adalimumab products, and a preferred ustekinumab/Stelara biosimilar where applicable, before brodalumab is approved.

Failure of a ≥3 month trial of one adalimumab product (preferred products: Hadlima, Simlandi, Yusimry, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp) unless contraindicated.
Failure of a ≥3 month trial of Taltz unless contraindicated.
Failure of a ≥3 month trial of one ustekinumab product or one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, Steqeyma) unless contraindicated.
Member must not be prescribed combination use with other biologic DMARDs or JAK inhibitors.

Guideline sourcePer 2019 AAD/NPF guidance referenced in policy