CurrentAvMedPolicy N/A

Bimzelx (bimekizumab-bkzx) prior authorization and step-edit

Pharmacy prior authorization and step-therapy requirements for Bimzelx (bimekizumab-bkzx) for AvMed members; defines documentation and trial/failure requirements for multiple indications and continuity rules.

Policy Summary

PayerAvMed

PolicyBimzelx (bimekizumab-bkzx) prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a prior authorization with complete documentation (signed prescriber info, diagnosis, dosing, and supporting chart notes or claims) — incomplete forms may delay or prevent approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

320 mgplaque psoriasis initial dose

160 mgPsA/axial/AS dosing

90 daysestablished-on requirement

3 monthsrequired trial duration

Specialtysupply channel

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Initial therapy - Plaque Psoriasis

Covered when ALL of the following are met for Moderate-to-Severe Plaque Psoriasis

Plaque Psoriasis - Overall: Member has a diagnosis of moderate-to-severe plaque psoriasis; prescribed by or in consultation with a Dermatologist; dosing per label: SUBQ 320 mg (two 160 mg injections) once every 4 weeks for the first 16 weeks (5 doses), then every 8 weeks thereafter; member tried and failed at least ONE of phototherapy or an alternative systemic therapy for at least 3 months3 months

Documentation (chart notes, phototherapy records, or pharmacy claims) required for each item

inv-02: Alternative Systemic Therapy

Alternative systemic therapy requirement (one of):

Alternative Systemic Therapies: Trial of oral medications such as acitretin, methotrexate, or cyclosporine for at least 3 months3 months

Check appropriate agents tried (chart notes or pharmacy paid claims)

inv-03: Preferred biologic trial/failure

Biologic step requirement (for multiple indications):

Biologic failures or contraindications: Member tried and failed, has a contraindication, or intolerance to TWO of the preferred biologics listed (verified by chart notes or pharmacy paid claims). Preferred biologics include adalimumab products, Enbrel, Otezla, Skyrizi, Sotyktu, Taltz, Tremfya, preferred ustekinumab product, Rinvoq, Xeljanz, Cimzia, Cosentyx as applicable by indication2 agents

Specific preferred agents required vary by indication and must be verified

inv-15: Initial Therapy Dosing & Requirements

Initial dosing and prerequisite trials vary by indication

Plaque psoriasis initial dosing: 320 mg subcutaneously (two 160 mg injections) once every 4 weeks for the first 16 weeks (5 doses), then every 8 weeks thereafter

Requires prior trial of phototherapy or alternative systemic therapy or failures of preferred biologics as specified

PsA/axial/AS dosing: 160 mg subcutaneously once every 4 weeks for Psoriatic Arthritis, non-radiographic axial spondyloarthritis, and Ankylosing Spondylitis (use plaque psoriasis dosing if coexisting moderate-to-severe plaque psoriasis)

Requires prior DMARDs or NSAID failures as specified

The Health Plan considers concomitant use of more than one biologic immunomodulator (for the same or different indications) to be experimental and investigational and will not be permitted. Safety and efficacy of combinations of biologic immunomodulators have not been established. Providers must indicate whether a previously prescribed biologic will be discontinued if the requested biologic is approved and document the medication to be discontinued and the medication to be initiated with effective dates.

Initial Therapy - Indication-specific Requirements

inv-15: Initial Therapy Dosing & Requirements

Initial dosing and prerequisite trials vary by indication (dosing, phototherapy/systemic requirements)

Plaque psoriasis - phototherapy/systemic requirement: Member tried and failed at least ONE of phototherapy (UV light therapy, NB UV-B, or PUVA) or an alternative systemic therapy (e.g., acitretin, methotrexate, cyclosporine) for at least 3 months3 months

Document type and dates of phototherapy or systemic therapy (chart notes or claims)

Hidradenitis Suppurativa - antibiotic requirement: For moderate-to-severe hidradenitis suppurativa, member tried and failed a 90-day course of oral antibiotics (e.g., tetracycline, minocycline, doxycycline, or clindamycin plus rifampin) within the last 9 months; name and date of antibiotic required90 days within 9 months

Provide antibiotic name and dates on form

inv-05: Indication-specific criteria

Criteria for other indications (Psoriatic Arthritis, Non-radiographic axial spondyloarthritis, Ankylosing Spondylitis, Hidradenitis Suppurativa):

Psoriatic Arthritis: Diagnosis of active psoriatic arthritis; prescribed by or in consultation with a Rheumatologist; member has tried and failed at least ONE DMARD for at least 3 months (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine); dosing: SUBQ 160 mg q4 weeks (use plaque dosing if coexisting moderate-to-severe plaque psoriasis)3 months

Trials verified by chart notes or pharmacy paid claims

Non-radiographic Axial Spondyloarthritis: Diagnosis of active non-radiographic axial spondyloarthritis; prescribed by or in consultation with a Rheumatologist; at least ONE objective sign of inflammation (elevated CRP or sacroiliitis on MRI); tried and failed, intolerant to, or contraindicated to TWO NSAIDs; dosing: SUBQ 160 mg q4 weeks

Failure to TWO NSAIDs must be documented; may require failure of preferred agents such as Cimzia or Rinvoq as indicated

Ankylosing Spondylitis: Diagnosis of active ankylosing spondylitis; prescribed by or in consultation with a Rheumatologist; member tried and failed, is intolerant to, or has contraindication to TWO NSAIDs; may require failure of preferred biologics (e.g., adalimumab products, Enbrel, Rinvoq, Taltz, Xeljanz); dosing: SUBQ 160 mg q4 weeks

Document NSAID trials and biologic failures or contraindications

Continuation Therapy / Established Users

inv-16: Continuation Therapy

Continuation allowed for members already established on Bimzelx

Established use continuation: Member has been on Bimzelx for at least 90 days AND prescription claims history indicates at least a 90-day supply of Bimzelx was dispensed within the past 130 days (verified by chart notes or pharmacy paid claims)90 days on drug; 90-day supply within 130 days

Allows continuation without meeting step failures; verified by chart notes or claims

inv-04: Continuation Therapy / Established Users

Established-on therapy continuation criteria (allow continuation without meeting step if established):

Continuation for established users: Member has been established on Bimzelx for at least 90 days and prescription claims history indicates at least a 90-day supply of Bimzelx was dispensed within the past 130 days>= 90-day supply dispensed within past 130 days

Verified by chart notes or pharmacy paid claims; permits continuation without meeting step therapy requirements

Established on Bimzelx (inv-14)

DefinitionMember has been on Bimzelx for at least 90 days and pharmacy claims show at least a 90-day supply dispensed within the past 130 days.

Verification methodVerified by chart notes or pharmacy paid claims (prescription claims history).

Applies toAllows continuation of Bimzelx without meeting step-failure requirements when established criteria met.

Step Therapy Requirements

Requirement	Details / verification
Failure/intolerance/contraindication to specified number of preferred biologics
Member tried and failed, has a contraindication, or intolerance to TWO of the PREFERRED biologics (verified by chart notes or pharmacy paid claims). Preferred biologics listed include adalimumab products, Enbrel, Otezla, Skyrizi, Sotyktu, Taltz, Tremfya, preferred ustekinumab product, Rinvoq, Xeljanz, Cimzia, Cosentyx (agents vary by indication).
Alternative non-biologic therapies requirement (when applicable)
For plaque psoriasis: trial and failure of at least ONE of phototherapy or an alternative systemic therapy (oral agents such as acitretin, methotrexate, or cyclosporine) for >= 3 months (verified by chart notes or pharmacy paid claims).
DMARD / NSAID trials for rheumatologic indications
For psoriatic arthritis: trial and failure of at least ONE DMARD (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) for >= 3 months. For non-radiographic axial spondyloarthritis and ankylosing spondylitis: tried and failed, intolerant to, or contraindicated to TWO NSAIDs (verified by chart notes).
Hidradenitis suppurativa specific requirement
Member tried and failed a 90-day course of oral antibiotics (e.g., tetracycline, minocycline, doxycycline, or clindamycin plus rifampin) within the last 9 months AND tried and failed or has contraindication/intolerance to BOTH preferred biologics (one preferred adalimumab product and Cosentyx). Name and date of antibiotic required; verification via chart notes or pharmacy paid claims.
Established-on therapy exception
Member established on Bimzelx for at least 90 days and prescription claims show at least a 90-day supply dispensed within the past 130 days — allows continuation without meeting step failures (verified by chart notes or pharmacy paid claims).

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Bimzelx (bimekizumab-bkzx). All clinical criteria on the PA form must be met and documented for approval. Incomplete, incorrect, or illegible forms and missing supporting documentation (e.g., lab results, diagnostic reports, chart notes) may delay or result in denial of the authorization.

Fax completed form to 1-305-671-0200
Prescribing physician must sign and clearly print name (preprinted stamps not valid)
Include member identifiers, prescriber contact information, drug form/strength, dosing schedule, length of therapy, diagnosis and ICD code

Step Therapy

Step Therapy and Preferred Agents

Step therapy applies. Member must have tried and failed (or have a documented contraindication or intolerance to) the specified preferred agents prior to approval unless member meets an established-on therapy exception (see below). Chart notes or pharmacy paid claims must verify prior trials.

For plaque psoriasis: failure of ONE of phototherapy or an alternative systemic therapy for ≥3 months, AND failure/contraindication/intolerance to TWO preferred biologics (e.g., preferred adalimumab product, Enbrel, Otezla/Otezla XR, Skyrizi, Sotyktu, Taltz, Tremfya, preferred ustekinumab product)
For psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, and other indications: documented failure/contraindication/intolerance to the specified number/type of DMARDs, NSAIDs, or preferred biologics listed on the form (see form for indication-specific lists)
Exception: Member is established on Bimzelx for ≥90 days with pharmacy claims showing at least a 90-day supply dispensed within the past 130 days — submit chart notes or pharmacy paid claims to verify

Documentation Required

Required Submission Details

Required submission details: The prescribing physician must sign and clearly print name on the request. The PA form must include member and prescriber details, drug form/strength, dosing schedule, length of therapy, diagnosis and ICD code, weight and date obtained (if applicable), and documentation supporting each checked clinical criterion (e.g., lab values, imaging reports, chart notes, and pharmacy claim history).

Document prior therapies tried, dates, durations, and reasons for discontinuation (failure, intolerance, or contraindication)
If switching from another biologic, indicate medication to be discontinued and medication to be initiated with effective dates
Provide objective signs where required (e.g., CRP level above ULN, MRI evidence of sacroiliitis)

Denial Risk

Incomplete or Missing Documentation May Delay or Deny Authorization

Incomplete or missing documentation: Authorization may be delayed or denied if the form is incomplete, incorrect, or illegible. Supporting documentation must be provided for each checked clinical box; use of samples to initiate therapy does not meet step-edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

If drug is non‑formulary for the member's plan, medical necessity documentation is required
Safety note: Concomitant use of more than one biologic immunomodulator is considered experimental/investigational and will not be permitted

Background

Bimekizumab (Bimzelx) is a biologic immunomodulator indicated for multiple inflammatory conditions, including moderate-to-severe plaque psoriasis. For plaque psoriasis the labeled dosing is SUBQ 320 mg (two 160 mg injections) once every 4 weeks for the first 16 weeks (5 doses) then every 8 weeks thereafter. The prior authorization form requires documentation of diagnosis, prescriber specialty (Dermatologist for plaque psoriasis), and supporting clinical evidence (e.g., phototherapy or alternative systemic therapy trials) for approval; incomplete documentation may delay or result in denial of the request.

Revision History

as writtenpolicy publication/contentLatest

Establishes prior authorization and step-therapy requirements for Bimzelx (bimekizumab-bkzx), including indication-specific dosing and required trials or failures (phototherapy, alternative systemic therapies, DMARDs, NSAIDs, preferred biologics) and continuation criteria for members established on Bimzelx.

as writtenclinical criterion addition

Defines established-user continuation criteria requiring at least 90 days on Bimzelx and pharmacy claims showing a 90-day supply dispensed within the past 130 days for continuation without meeting step failures.

as writtencoverage detail

Specifies that concomitant use of more than one biologic immunomodulator is considered experimental/investigational and will not be permitted.

Policy Summary

PayerAvMed

PolicyBimzelx (bimekizumab-bkzx) prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a prior authorization with complete documentation (signed prescriber info, diagnosis, dosing, and supporting chart notes or claims) — incomplete forms may delay or prevent approval.

SourceLink

On This Page

Hidradenitis Suppurativa: Diagnosis of moderate-to-severe hidradenitis suppurativa; prescribed by or in consultation with a Dermatologist; member tried and failed a 90-day course of oral antibiotics for HS within the last 9 months; member tried and failed, or has contraindication/intolerance to BOTH preferred biologics (one preferred adalimumab product and Cosentyx [secukinumab]); dosing: SUBQ 320 mg once every 2 weeks for the first 16 weeks (9 doses), then every 4 weeks thereafter90 days antibiotics within 9 months

Name and date of antibiotic required; biologic failures verified by chart notes or pharmacy paid claims

OpenPayer

Bimzelx (bimekizumab-bkzx) prior authorization and step-edit

Coverage Criteria for Bimzelx (bimekizumab-bkzx)

Initial Therapy - Indication-specific Requirements

Continuation Therapy / Established Users

Step Therapy Requirements

Diagnosis and Coding

Provider Actions & Documentation Requirements

Medication Dispensing and Site of Care

Background

Definitions

Revision History