CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Bimzelx (bimekizumab) — Coverage Criteria

Defines medical necessity, authorization durations, dosing, and documentation requirements for Bimzelx (bimekizumab) for adults with plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBimzelx (bimekizumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionSubmit the member's chart or medical record documenting medical necessity, including BSA or crucial body area involvement and prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5FDA-approved indications listed

4 moPlaque psoriasis initial auth

12 moMax continuation auth

DefinedQuantity limits

Coverage Criteria

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Universal Criteria

Covered when ALL of the following general conditions are met

Universal requirements: Member is ≥18 years old; Bimzelx will not be used concomitantly with another injectable biologic response modifier or specified oral non-biologic targeted agents; member has documentation of a negative tuberculosis (TB) test within 6 months if biologic- or targeted‑synthetic‑naïve; submission of the member's chart or medical record documenting medical necessity.

Concomitant biologic or targeted synthetic therapy prohibited; TB testing requirement applies to biologic-naïve members.

Initial Therapy — Plaque Psoriasis

Plaque psoriasis — Initial authorization

Plaque Psoriasis initial: Bimzelx prescribed by or in consultation with a dermatology specialist; documentation of at least 10% body surface area (BSA) affected OR involvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); meets ALL prior therapy requirements: (i) inadequate response or intolerance to at least a 3‑month trial of methotrexate, cyclosporine, or acitretin OR inadequate response or intolerance to at least a 3‑month trial of phototherapy (unless intolerant); (ii) inadequate response, intolerance, or contraindication to at least a 3‑month trial of adalimumab AND at least a 6‑month trial of an ustekinumab biosimilar at maximum tolerated doses; (iii) inadequate response, intolerance, or contraindication to at least one additional listed psoriasis medication (e.g., roflumilast, etanercept, secukinumab, risankizumab, infliximab products, tildrakizumab, guselkumab, apremilast).BSA ≥ 10% or crucial body areas involvement

Authorization of 4 months may be granted for initial therapy.

Continuation Therapy — Plaque Psoriasis

Plaque psoriasis — Continuation authorization

Plaque Psoriasis continuation: Member demonstrates a positive clinical response from baseline as evidenced by: reduction in BSA affected OR improvement in signs and symptoms (e.g., itching, redness, flaking, scaling, burning, cracking, pain). If request is for Bimzelx 320 mg every 4 weeks (escalated dosing), provider must submit medical rationale including current weight and documentation of clinically meaningful incremental benefit after at least 16 weeks on therapy.

Authorization of 12 months may be granted.

Initial Therapy — Psoriatic Arthritis

Psoriatic arthritis — Initial authorization

PsA initial: Bimzelx prescribed by or in consultation with a dermatology or rheumatology specialist; documented moderate to severe active psoriatic arthritis; member meets either (a) predominantly axial disease or active enthesitis/dactylitis with inadequate response or intolerance to at least two NSAIDs unless contraindicated, OR (b) peripheral arthritis with inadequate response to a ≥3‑month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine) unless intolerant; plus inadequate response, intolerance, or contraindication to at least a 3‑month trial of adalimumab and at least a 6‑month trial of an ustekinumab biosimilar at maximum tolerated doses.

Authorization of 6 months may be granted.

Continuation Therapy — Psoriatic Arthritis

Psoriatic arthritis — Continuation authorization

PsA continuation: Member demonstrates improvement from baseline in any of the following: number of swollen joints; number of tender joints; dactylitis; enthesitis; skin and/or nail involvement; or disease activity scoring tool (e.g., improvement in ≥2 of 4 PsARC with no worsening in any criteria, with one of the improved criteria being joint tenderness or swelling).

Authorization of 12 months may be granted.

Initial Therapy — Non-Radiographic Axial Spondyloarthritis

Non-radiographic axial spondyloarthritis — Initial authorization

nr-axSpA initial: Prescribed by or in consultation with a dermatology or rheumatology specialist; documented active disease with objective signs of inflammation (elevation of C‑reactive protein above the upper limit of normal and/or sacroiliitis on MRI); absence of definitive radiographic structural damage of the sacroiliac joints; inadequate response or contraindication to two NSAIDs; and inadequate response, intolerance, or contraindication to at least a 3‑month trial of adalimumab at maximum tolerated doses.

Authorization of 6 months may be granted.

Continuation Therapy — Non-Radiographic Axial Spondyloarthritis

Non-radiographic axial spondyloarthritis — Continuation authorization

nr-axSpA continuation: Member demonstrates improvement from baseline in any of: total back pain; physical function; reduction in C‑reactive protein; or disease activity scoring tool (e.g., ≥1.1 improvement on ASDAS or ≥2 improvement on BASDAI).

Authorization of 12 months may be granted.

Initial Therapy — Ankylosing Spondylitis

Ankylosing spondylitis — Initial authorization

AS initial: Bimzelx prescribed by or in consultation with a rheumatology specialist; documented active ankylosing spondylitis; inadequate response or intolerance to at least two NSAIDs over a total of 4 weeks unless contraindicated; and inadequate response, intolerance, or contraindication to at least a 3‑month trial of adalimumab at maximum tolerated doses.

Authorization of 6 months may be granted.

Continuation Therapy — Ankylosing Spondylitis

Ankylosing spondylitis — Continuation authorization

AS continuation: Member demonstrates improvement from baseline in any of: functional status; total spinal pain; inflammation (e.g., morning stiffness); or disease activity scoring tool (e.g., ≥1.1 improvement on ASDAS or ≥2 improvement on BASDAI).

Authorization of 12 months may be granted.

Initial Therapy — Hidradenitis Suppurativa

Hidradenitis suppurativa — Initial authorization

HS initial: Prescribed by or in consultation with a dermatology specialist; documented moderate to severe hidradenitis suppurativa; either inadequate response to oral antibiotics for at least 90 days OR intolerance/contraindication to oral antibiotics; and inadequate response, intolerance, or contraindication to at least a 3‑month trial of adalimumab at maximum tolerated doses.

Authorization of 6 months may be granted.

Continuation Therapy — Hidradenitis Suppurativa

Hidradenitis suppurativa — Continuation authorization

HS continuation: Member demonstrates improvement from baseline in measures such as reduction in abscess and inflammatory nodule count; reduced formation of new sinus tracts and scarring; decreased frequency of inflammatory lesions; reduction in pain or suppuration; improved relapse frequency; improvement in quality of life; or improvement on a disease severity assessment tool.

Authorization of 12 months may be granted.

All indications other than the FDA‑approved indications listed for Bimzelx are considered experimental / investigational and not medically necessary. Requests for use outside the approved indications may be denied.

Use of Bimzelx for indications not included in the FDA‑Approved Indication is considered not medically necessary and will not be covered.

Provider Actions and Requirements

Prior Authorization

Initial authorization — PsA, nr-axSpA, AS, HS

Authorization of 6 months may be granted for treatment of active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS) when the indication-specific criteria and prior therapy requirements are met. See indication-specific criteria for required specialist consultation, documentation of active disease, objective inflammatory markers (for nr-axSpA), and prior NSAID/DMARD/biologic trials as applicable.

PsA: specialist dermatology or rheumatology consult; documented moderate-severe active disease; prior NSAID/DMARD and specified biologic trials required
nr-axSpA/AS: specialist rheumatology (or dermatology for nr-axSpA), documented active disease; objective signs (CRP elevation and/or MRI sacroiliitis) required for nr-axSpA; inadequate response to ≥2 NSAIDs; prior adalimumab trial required
HS: specialist dermatology consult; documented moderate-severe disease with inadequate response to ≥90 days oral antibiotics (or intolerance/contraindication); prior adalimumab trial required

Denial Risk

Non‑approved indications

Requests for indications not listed as FDA‑approved (or compendial uses specified in the policy) are considered experimental/investigational and are not medically necessary. Provide supporting rationale and literature will not make an unlisted indication payable.

Documentation Required

Medical record and prior therapy documentation

Submission of the member's chart or medical record is required and must document medical necessity per the applicable indication. Lack of an adequate medical record or missing required documentation (including prior therapy details) may result in denial.

Include specialist consultation notes, treatment history with durations and doses, and objective disease measures where applicable (e.g., BSA for psoriasis, CRP/MRI for nr-axSpA)

Documentation Required

TB testing and weight documentation

Members who are biologic‑naïve or naïve to targeted synthetic drugs associated with increased TB risk must have documentation of a negative TB test (PPD, IGRA, or chest x‑ray) within 6 months prior to initiating therapy. When request involves weight‑based dosing changes or quantity limit exception (e.g., maintenance dosing for members ≥120 kg or induction regimens), include up‑to‑date weight documentation and clinical rationale.

Negative TB test within 6 months required for biologic‑naïve members
Provide current weight when requesting dose/quantity limit exceptions (e.g., weight ≥120 kg for maintenance plaque psoriasis/psoriatic arthritis dosing)

Step Therapy

Prior therapy requirements

Most indications require documented inadequate response, intolerance, or contraindication to specified prior systemic therapies before authorization is granted. Ensure therapy trials include duration and reason for failure/intolerance.

Plaque psoriasis: inadequate response or intolerance to topical/systemic therapies and phototherapy as specified (including trials of methotrexate/cyclosporine/acitretin or phototherapy, and prior biologic trials such as adalimumab and ustekinumab biosimilar)
PsA: inadequate response/intolerance to ≥2 NSAIDs (axial/enthesitis/dactylitis) or ≥3 months of an oral DMARD for peripheral arthritis; prior trials of adalimumab and ustekinumab biosimilar required
nr-axSpA/AS: inadequate response or contraindication to TWO NSAIDs; prior adalimumab trial required
HS: inadequate response to ≥90 days oral antibiotics (or intolerance/contraindication); prior adalimumab trial required

Denial Risk

Documentation and TB testing

Failure to submit the member chart or medical record documenting medical necessity, or missing required TB testing or weight documentation for dose exceptions, may trigger denial of the request. Verify all required prior therapy trials, durations, specialist consultation, and objective measures are included before submission.

Product Strengths, Quantity Limits, and Key Values

Quantity-limited product strengthsmixedCovered

Bimzelx 160mg/ml	Quantity limit: 1 syringe/autoinjector pen or 1 ml per 28 days
Bimzelx 320mg/2ml	Quantity limit: 1 syringe/autoinjector pen or 2 ml per 56 days

Quantity-limited product strengths — exceptions (induction/weight/HS)mixedCovered

Bimzelx 320mg/2ml (induction - plaque psoriasis or PsA with coexisting plaque psoriasis)	Quantity limit exception: induction regimen of 5 initial loading doses of 320mg/2ml per 28 days
Bimzelx 320mg/2ml (maintenance - ≥120 kg, plaque psoriasis or PsA with coexisting plaque psoriasis)	Quantity limit exception: 320mg/2ml per 28 days for maintenance with documentation of weight ≥120 kg and medical rationale
Bimzelx 320mg/2ml (induction - hidradenitis suppurativa)	Quantity limit exception: two doses of 320mg/2ml per 28 days for 16 weeks (induction), then 320mg/2ml per 28 days for maintenance

Body Surface Area (BSA) threshold

ThresholdBSA ≥ 10% affected

Alternate qualifying findingInvolvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Documentation requirementProvider must document BSA percentage or note involvement of crucial body areas in the medical record

Weight threshold for dose escalation

Weight cutoff for dose escalation≥ 120 kg — consider 320 mg SC every 4 weeks after week 16

Documentation requiredMember weight must be documented when requesting dose escalation or quantity limit exception

Quantity limit exceptionMaintenance 320mg/2ml per 28 days may be provided if member ≥120 kg with documentation and medical rationale

Definitions

Crucial body areas

Defined sitesHands, feet, face, neck, scalp, genitals/groin, intertriginous areas

Clinical significanceInvolvement of these areas can justify systemic therapy despite lower overall BSA

Documentation guidanceProvider must note specific crucial body area involvement in the member's chart/medical record

Objective signs of inflammation (nr-axSpA)

Objective inflammation criteriaElevation of C-reactive protein (CRP) above the upper limit of normal

Imaging evidenceSacroiliitis on magnetic resonance imaging (MRI)

ApplicationAt least one of these objective signs is required for nr-axSpA initial authorization

Background

Bimzelx (bimekizumab) is FDA‑approved for the treatment of adults with: (1) moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy; (2) active psoriatic arthritis (PsA); (3) active non‑radiographic axial spondyloarthritis (nr‑axSpA) with objective signs of inflammation; (4) active ankylosing spondylitis (AS); and (5) moderate to severe hidradenitis suppurativa (HS).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBimzelx (bimekizumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionSubmit the member's chart or medical record documenting medical necessity, including BSA or crucial body area involvement and prior therapy trials.

SourceLink

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