Clinical Policy: Brodalumab (Siliq)
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Covers Meridian's medical necessity and prior authorization criteria for brodalumab (Siliq) for treatment of moderate-to-severe plaque psoriasis in adults under Meridian IL Medicaid and affiliated Centene plans.
No material clinical or coverage changes in this revision.
Coverage Criteria — Brodalumab (Siliq)
inv-01: Initial Therapy
Covered when ALL of the following are met:
inv-02: Continuation Therapy
Covered when ALL of the following are met:
Approval duration: 6 months
Non‑FDA approved indications: Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless there is sufficient documentation of efficacy and safety consistent with the plan's off‑label use policy (CP.PMN.53) and applicable evidence of coverage documents. Specifically, treatment of Crohn's disease is not authorized.
Requests for therapy in combination with other potent immunomodulatory agents are not authorized. Combination use with biological disease‑modifying antirheumatic drugs (bDMARDs), potent immunosuppressants, Janus kinase inhibitors, anti‑CD20 agents, selective co‑stimulation modulators, integrin receptor antagonists, tyrosine kinase 2 inhibitors, and sphingosine‑1‑phosphate (S1P) receptor modulators is prohibited because of risks related to additive immunosuppression, neutropenia, and serious infections.
State Medicaid coverage provisions and applicable law take precedence over this clinical policy when conflicts exist. Providers and reviewers must follow the applicable state Medicaid manual, the member's evidence of coverage, and other plan coverage documents when making coverage determinations.
Use of brodalumab for indications that are not FDA‑approved and are not supported by sufficient evidence per the plan's off‑label use policy will not be authorized. Likewise, regimens that combine brodalumab with the prohibited combinations listed in Section III (e.g., bDMARDs, JAK inhibitors, anti‑CD20 agents, potent immunosuppressants, selective co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, S1P modulators) are considered not medically necessary and will be denied.
Coding and Clinical Thresholds
Provider Actions and Prior Authorization
Prior authorization required
Prior authorization is required for brodalumab (Siliq); approval is contingent on documented trials/failures of specified conventional systemic therapies and at least two listed biologics each used for ≥3 consecutive months unless contraindicated or intolerant.
- Conventional systemic therapy requirement (e.g., methotrexate ≥3 months or cyclosporine if MTX intolerant) and phototherapy when applicable.
- Failure of at least two biologics (examples: Enbrel, adalimumab products, Cimzia) each for ≥3 consecutive months.
Prior authorization guidance
This clinical policy provides medical necessity criteria to guide coverage decisions for brodalumab (Siliq); prior authorization requirements are governed by the Health Plan's administrative policies and the member's benefit documents.
- Policy MDN.CP.PHAR.375 defines the medical necessity criteria used to evaluate requests.
- Administrative prior authorization processes remain subject to Health Plan-level policies and member coverage documents.
Step therapy prerequisites
Before brodalumab is authorized, the member must have documented failure of methotrexate (≥3 consecutive months) or, if MTX is intolerant/contraindicated, cyclosporine (≥3 months); phototherapy failure is required if MTX and cyclosporine are not appropriate. Additionally, failure of at least two listed biologics each for ≥3 consecutive months is required.
- Methotrexate trial: ≥3 consecutive months at up to maximally indicated doses unless contraindicated or adverse effects occur.
- If MTX intolerance/contraindication: cyclosporine trial ≥3 consecutive months at up to maximally indicated doses.
- If both MTX and cyclosporine intolerant/contraindicated: phototherapy failure required.
- At least two of Enbrel, adalimumab products (including specified biosimilars), or Cimzia used ≥3 consecutive months each.
Step therapy / preferred product updates
The policy was reviewed and updated to reflect changes to preferred adalimumab products; programmatic step edits or preferred-product edits at the plan level may be implemented accordingly.
- 2025 annual review updated preferred adalimumab products and noted references were reviewed.
Required documentation
Providers must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria when requesting authorization for brodalumab.
- Include documentation of prior therapy trials, durations, outcomes, and any contraindications or intolerances.
Documentation and coverage governance
Providers must follow the Health Plan's coverage documents and applicable state and federal requirements; documentation submitted should support medical necessity per this clinical policy.
- Coverage decisions are subject to the terms, conditions, exclusions and limitations of the member's coverage documents.
- If discrepancies exist between this policy and legal/regulatory requirements, law and regulation govern.
Non‑authorized indications
Requests for non‑FDA approved indications that lack sufficient documentation of efficacy and safety per the off‑label use policy will not be authorized.
- Examples include indications not addressed in this policy (see Section III) such as Crohn's disease.
- Off‑label coverage requires sufficient supporting documentation per policy CP.PMN.53 (Medicaid).
Combination therapy exclusion
Requests that propose combination therapy with biological DMARDs, potent immunosuppressants, JAK inhibitors, anti‑CD20 agents, or other specified biologics will be denied due to additive immunosuppression and increased infection risk.
- Combination use with TNF antagonists, interleukin agents, JAK inhibitors, anti‑CD20 antibodies, selective co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, or S1P modulators is not authorized.
Coverage decision dependencies
Coverage decisions for brodalumab are subject to the member's coverage documents and to state and federal requirements; the Health Plan's administrative policies and applicable laws govern any discrepancies.
- This clinical policy is a guide to medical necessity and does not guarantee payment; benefits are administered per the evidence of coverage and contract terms.
Background
BACKGROUND: Brodalumab (Siliq) is an interleukin‑17A receptor antagonist indicated for treatment of moderate‑to‑severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed or lost response to other systemic therapies. The agent carries important safety considerations: it is contraindicated in patients with Crohn's disease and has a boxed warning for suicidal ideation and behavior. Dosing for adults follows the manufacturer guidance used in this policy (initial 210 mg at weeks 0, 1 and 2, then 210 mg every 2 weeks).
Definitions and Safety Information
Initial Therapy Criteria
inv-21: Initial Therapy
Initial therapy requirements for plaque psoriasis — covered when ALL of the following are met:
Initial approval duration: 6 months
Continuation Therapy Criteria
inv-22: Continuation
Continued therapy approvals require ongoing response and absence of prohibited combinations:
Continued approvals typically granted for 12 months per policy guidance
Step Therapy Requirements
| Step | Requirement | Duration / Notes |
|---|---|---|
| 1 | Trial of methotrexate (MTX) at up to maximally indicated doses unless contraindicated or intolerant | ≥3 consecutive months unless contraindicated; if MTX is intolerant/contraindicated, trial of cyclosporine is acceptable |
| 2 | If MTX intolerance/contraindication, trial of cyclosporine at up to maximally indicated doses | ≥3 consecutive months unless contraindicated; if both MTX and cyclosporine are intolerant/contraindicated, phototherapy is an alternative |
| 3 | Failure of at least TWO biologic agents chosen from listed alternatives (examples: Enbrel [etanercept], adalimumab products, Cimzia [certolizumab]) | Each biologic used for ≥3 consecutive months unless contraindicated or intolerant; documented failure, loss of response, or intolerance required |
Quantity Limits
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