CurrentmhnPolicy CP.PHAR.660

Clinical Policy: Bimekizumab-bkzx (Bimzelx)

Defines medical necessity criteria, dosing limits, prescriber requirements, prior authorization expectations, and excluded uses for Bimzelx (bimekizumab-bkzx) across indications: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis/non-radiographic axial spondyloarthritis, and hidradenitis suppurativa for Medicaid members.

Policy Summary

Payermhn

PolicyClinical Policy: Bimekizumab-bkzx (Bimzelx)

Policy CodePolicy CP.PHAR.660

Change TypeMultiple RT4 and annual review updates (added indications, strengths, exclusions, and criteria revisions)

Effective Date03.01.24

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member has met all approval criteria; prior authorization may be required for listed comparators.

POLICY UPDATE CHANGES

Added criteria for newly approved indications for PsA, AS, and nr-axSpA; added criteria for HS when approved.

Added new product strength 320 mg/2 mL for single-dose prefilled syringe/autoinjector.

For HS, added bypass of preferred adalimumab redirection when contraindicated or clinically significant adverse effects are experienced.

Added requirement that member does not have combination use with bDMARDs or JAK inhibitors for PsO, PsA, AS, and HS.

Extended initial approval durations to 12 months for chronic conditions.

Updated Section III.B list of excluded combination agents to include newer agents (Wezlana, Sotyktu, Velsipity, Spevigo) and biosimilar verbiage.

5FDA-approved indications listed

12 months

Approval duration (chronic)

≥3 monthsComparator trial length

≥18Minimum age for coverage

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines medical necessity criteria, dosing limits, prescriber requirements, prior authorization expectations, and excluded uses for bimekizumab-bkzx (Bimzelx) across FDA-approved indications: plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS). Background: Bimekizumab-bkzx is covered when indication-specific criteria are met (including specialist prescriber requirements, age ≥ 18, prior trials of specified conventional or biologic therapies where applicable, and dosing limits), combination use with other potent immunosuppressants/bDMARDs/JAK inhibitors is excluded due to additive immunosuppression and infection risk, and approval durations for chronic conditions are set to 12 months. The policy aligns coverage to guideline-based step therapy and biologic trial history per referenced guideline sources.

Key thresholds and limits

Minimum age≥ 18 years

Plaque Psoriasis BSA threshold≥ 3% of total body surface area

HS response metric for continuation≥ 25% reduction in inflammatory nodules and abscesses

NSAID trial requirement for AS/nr-axSpAFailure of at least 2 NSAIDs, each used ≥ 4 weeks

Conventional therapy trial length (e.g., MTX)≥ 3 consecutive months

Approval duration12 months

Approval/ dosing referencesIndication-specific dosing and dose limits per policy and product labeling (e.g., PsO: 320 mg loading then q8w; PsA/AS/nr-axSpA: 160 mg q4w; HS: 320 mg loading then q4w)

Plaque Psoriasis — Initial Therapy (must meet all)

Plaque Psoriasis - Initial Therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

ONE of
- ≥ 3% of total body surface area
- Involvement of hands, feet, scalp, face, or genital area
Prescribed by or in consultation with a dermatologist or rheumatologist
Age ≥ 18 years
ONE of

Psoriatic Arthritis — Initial Therapy (must meet all)

Psoriatic Arthritis - Initial Therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of psoriatic arthritis (PsA)
Prescribed by or in consultation with a dermatologist or rheumatologist
Age ≥ 18 years
Failure of ALL of the following
- One adalimumab product (preferred examples listed), unless member has history of failure of two TNF blockers

Axial Spondylitis (AS or nr-axSpA) — Initial Therapy (must meet all)

Axial Spondylitis (AS or nr-axSpA) - Initial Therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA)
Prescribed by or in consultation with a rheumatologist
Age ≥ 18 years
Failure of at least TWO NSAIDs at up to maximally indicated doses, each used for ≥ 4 weeks unless adverse effects, contraindicated, or previously failed a biologic agent for AS
For AS: failure of ALL of

Hidradenitis Suppurativa — Initial Therapy (must meet all)

Hidradenitis Suppurativa - Initial Therapy (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of hidradenitis suppurativa (HS)
Prescribed by or in consultation with a dermatologist, rheumatologist, or gastroenterologist
Age ≥ 18 years
Documentation of Hurley stage II or stage III
ONE of

Other Diagnoses / Off-Label Use

Other diagnoses/indications

If criteria below are met

ANY of the following

If drug has recently undergone a label change within last 6 months not reflected in policy, follow formulary/no-coverage or non-formulary policy as applicable (CP.PMN.255 or CP.PMN.16 for Medicaid)
If requested use is not listed and label-change rule does not apply, refer to off-label use policy CP.PMN.53 for Medicaid

Continuation Therapy — All Indications (must meet all)

Continued Therapy - All Indications (must meet all)

Covered for continuation when ALL of the following are met:

ALL of the following

ONE of
- Currently receiving medication via Centene benefit or previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
ONE of
- For HS: At least a 25% reduction in inflammatory nodules and abscesses

Applicable Codes

HCPCS - InformationalHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Provider Actions

Prior Authorization

Documentation required for approval

Providers must submit office chart notes, lab results, or other clinical documentation supporting that the member meets all approval criteria. Prior authorization may be required for listed comparator agents (examples include adalimumab products, Taltz, ustekinumab products).

Documentation Required

Prescriber specialty requirement

Prescriptions must be by or in consultation with the specialty appropriate to the indication: dermatology or rheumatology for plaque psoriasis and psoriatic arthritis; rheumatology for axial spondylitis (AS or nr‑axSpA); dermatology, rheumatology, or gastroenterology for hidradenitis suppurativa.

Clinical Evidence & Background

Background: Bimekizumab-bkzx is a humanized interleukin-17A and F antagonist (mechanism). FDA-approved indications include moderate-to-severe plaque psoriasis, active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective inflammation, active ankylosing spondylitis, and moderate-to-severe hidradenitis suppurativa. Dosing regimens and product availability include induction and maintenance schedules specific to each indication and availability as 160 mg/mL and 320 mg/2 mL single-dose prefilled syringes and autoinjectors. The policy aligns coverage to guideline-based step therapy and biologic trial history (AAD-NPF, ACR, EULAR and other referenced guidelines) and restricts combination use with other potent immunosuppressants/bDMARDs/JAK inhibitors because of additive immunosuppression, increased risk of neutropenia, and increased risk of serious infections.

Evidence sources and trial metrics

Primary ReferenceBimzelx Prescriber Information, UCB, November 2024

Guideline sources referencedAAD‑NPF, ACR, EULAR and others (2019–2024 updates) as listed in policy references

Definitions

Term	Definition
PsO
Plaque psoriasis
PsA
Psoriatic arthritis
AS
Ankylosing spondylitis
nr-axSpA
Non-radiographic axial spondyloarthritis
HS
Hidradenitis suppurativa
MTX
Methotrexate

Revision History

2024-01-30added

2Q2024 annual review: added Wezlana, Sotyktu, and Velsipity to Section III.B exclusions; references reviewed and updated. (P&T approval noted in revision log.)

2024-09-26added

RT4: added criteria for newly approved indications for psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA); added requirement in PsO and continued therapy that member does not have combination use with bDMARDs or JAK inhibitors per competitor analysis. (P&T approval date 11.24 recorded.)

2024-09-26added

RT4: added new product strength 320 mg/2 mL for single-dose prefilled syringe and single-dose prefilled autoinjector (product availability updated to include 320 mg/2 mL).

Policy Summary

Payermhn

PolicyClinical Policy: Bimekizumab-bkzx (Bimzelx)

Policy CodePolicy CP.PHAR.660

Change TypeMultiple RT4 and annual review updates (added indications, strengths, exclusions, and criteria revisions)

Effective Date03.01.24

Next Review Date

On This Page

Failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses
Intolerance or contraindication to MTX, AND failure of a ≥ 3 consecutive month trial of cyclosporine or acitretin at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated
Intolerance or contraindication to MTX, cyclosporine, and acitretin, AND failure of phototherapy, unless contraindicated or clinically significant adverse effects are experienced

ONE of

Failure of a ≥ 3 consecutive month trial of one adalimumab product (preferred examples listed)
History of failure of two TNF blockers

Failure of a ≥ 3 consecutive month trial of ixekizumab (Taltz), unless contraindicated or clinically significant adverse effects are experienced

Prior authorization may be required for Taltz

Failure of a ≥ 3 consecutive month trial of one ustekinumab product (preferred examples listed), unless clinically significant adverse effects are experienced or all are contraindicated

Prior authorization may be required for ustekinumab products

No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors

See Section III for non-authorized combinations

Dose limit (ONE of)

320 mg at weeks 0, 4, 8, 12, and 16, then every 8 weeks
Weight ≥ 120 kg: 320 mg at weeks 0, 4, 8, 12, and 16, then every 4 weeks

Denial Risk

Combination therapy exclusion

Coverage is not authorized for combination use of Bimzelx with other potent immunosuppressants. Specifically, combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants — including but not limited to tumor necrosis factor (TNF) antagonists, interleukin agents, Janus kinase inhibitors (JAKi), anti‑CD20 monoclonal antibodies, selective co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, or sphingosine 1‑phosphate (S1P) modulators — is excluded. Claims submitted for Bimzelx when used concurrently with these agent classes are at risk of denial.

Documentation Required

Prescriber specialty requirement

Prescriptions must be by or in consultation with the specified specialist for the indication: dermatologist or rheumatologist for plaque psoriasis and psoriatic arthritis; rheumatologist for axial spondylitis (AS/nr‑axSpA); dermatologist, rheumatologist, or gastroenterologist for hidradenitis suppurativa.

Taltz (ixekizumab)

Prior authorization may be required for Taltz

One ustekinumab product (preferred examples listed)

If member has not responded or is intolerant to one or more TNF blockers, Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefits

No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors

See Section III for non-authorized combinations

Dose limit (ONE of)

PsA alone: 160 mg every 4 weeks
PsA with coexistent PsO: 320 mg at weeks 0, 4, 8, 12, and 16, then every 8 weeks
PsA with coexistent PsO AND weight ≥ 120 kg: 320 mg at weeks 0, 4, 8, 12, and 16, then every 4 weeks

Billing Rule

Dose limits enforcement

Claims for doses or frequencies that exceed the indication‑specific dosing limits listed in the policy are subject to denial. Approval durations for initial and continued therapy for chronic indications are limited to 12 months.

One adalimumab product (preferred examples listed), unless history of failure of two TNF blockers
Taltz (ixekizumab)
Prior authorization may be required for Taltz
If member has not responded or is intolerant to one or more TNF blockers, Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefits

For nr-axSpA: Failure of Taltz used for ≥ 3 consecutive months, unless contraindicated or adverse effects experienced

Prior authorization may be required for Taltz

No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors

See Section III for non-authorized combinations

Dose does not exceed 160 mg every 4 weeks

Note: The policy allows bypassing certain conventional therapy requirements if the member has previously failed a biologic for ankylosing spondylitis (AS); this intent and related edits were incorporated in RT4/annual updates to clarify that members who have failed a biologic may not be required to step back to conventional therapies.

Failure of one adalimumab product (preferred examples listed)

History of failure of two TNF blockers

Adalimumab contraindicated or clinically significant adverse effects are experienced

Failure of at least TWO systemic therapies from different classes, each tried for ≥ 3 consecutive months (e.g., systemic antibiotics, oral retinoids, hormonal treatment), unless adverse effects or contraindicated or previously failed a biologic agent for HS

No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors

See Section III for non-authorized combinations

Dose does not exceed 320 mg at weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks

Step Therapy

Adalimumab bypass update (2Q2025)

For hidradenitis suppurativa (2Q2025 update), when adalimumab is contraindicated or causes clinically significant adverse effects, the policy allows bypass of the preferred adalimumab redirection — permitting consideration of Bimzelx without requiring trial of a preferred adalimumab product.

For all other indications: Member is responding positively to therapy

No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors

See Section III for non-authorized combinations

Dose increase limits (ONE of)

PsA, AS, nr-axSpA: 160 mg every 4 weeks
PsO (with or without coexistent PsA): 320 mg every 8 weeks; Weight ≥ 120 kg: 320 mg every 4 weeks
HS: 320 mg every 4 weeks

Billing Rule

Claims exceeding dosing are subject to denial

Claims that exceed the policy’s indication‑specific dosing regimens or frequencies are subject to denial. Initial and continued approvals for chronic indications are limited to 12 months.

Billing Rule

Dose limits enforcement

Claims for doses or frequencies that exceed the policy’s specified dosing limits per indication (see policy dosing tables) are subject to denial. Approval durations for chronic conditions are limited to 12 months.

Denial Risk

Combination therapy exclusion

Coverage is not authorized for combination use of Bimzelx with bDMARDs or other potent immunosuppressants. Listed excluded classes include TNF antagonists, interleukin agents, JAK inhibitors, anti‑CD20 agents, selective co‑stimulation modulators, integrin antagonists, TYK2 inhibitors, and S1P modulators. Claims for Bimzelx submitted with concurrent use of these agent classes are at risk of denial.

2024-11-24added

RT4: added newly approved indication for hidradenitis suppurativa (HS). (P&T approval date 02.25 noted in log.)

2025-01-23revised

2Q2025 annual review: for HS, added bypass of preferred adalimumab redirection when adalimumab is contraindicated or clinically significant adverse effects are experienced; updated Section III.B with Spevigo and biosimilar verbiage; references reviewed and updated. (P&T approval date 05.25 recorded.)

2025-04-23revised

Per April SDC: for PsO and PsA, added requirement to use one preferred ustekinumab (Stelara) biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, Steqeyma preferred). (P&T approval date 06.25 recorded.)

2025-06-25revised

Per June SDC: clarified bypass of conventional therapies for PsO, AS, and HS when member has failed a biologic agent to avoid stepping back to conventional therapy; extended initial approval durations to 12 months for chronic conditions. (P&T approval date 11.25 recorded.)