CurrentMass General Brigham Health PlanPolicy N/A

Bimzelx (bimekizumab-bkzx) prior authorization for indicated immune-mediated dermatologic and rheumatologic conditions

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Defines pharmacy prior authorization, specialty pharmacy dispensing, clinical criteria, and reauthorization rules for Bimzelx for commercial/exchange members of Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBimzelx (bimekizumab-bkzx) prior authorization for indicated immune-mediated dermatologic and rheumatologic conditions

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical/coverage changes

Effective DateMay 1, 2026

Last ReviewMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization through the pharmacy benefit and ensure medication is dispensed via a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 months

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CurrentMass General Brigham Health PlanPolicy N/A

Bimzelx (bimekizumab-bkzx) prior authorization for indicated immune-mediated dermatologic and rheumatologic conditions

Customize your policy alerts

Sign up for all Mass General Brigham Health Plan policy alerts

Know when Mass General Brigham Health Plan releases new policies or updates existing guidance.

Monitor payer policy activity

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Defines pharmacy prior authorization, specialty pharmacy dispensing, clinical criteria, and reauthorization rules for Bimzelx for commercial/exchange members of Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBimzelx (bimekizumab-bkzx) prior authorization for indicated immune-mediated dermatologic and rheumatologic conditions

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical/coverage changes

Effective DateMay 1, 2026

Last ReviewMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization through the pharmacy benefit and ensure medication is dispensed via a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 months

approval and reauthorization length

1 injection/28 daysquantity limit

Commercial/Exchangeplan type

Specialty requireddispensing

PsO, PsA, AS, nr-axSpA, HScovered indications

Coverage Criteria for Bimzelx (bimekizumab-bkzx)

Initial Therapy - Plaque Psoriasis

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

Plaque Psoriasis Initial Criteria: 1. Diagnosis of moderate to severe plaque psoriasis; 2. At least 3% of body surface area (BSA) is affected OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected; 3. Member meets ONE of the following: (a) Minimum duration of 4-week trial and failure, contraindication, or intolerance to ONE topical therapy (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar); OR (b) severe psoriasis that warrants a biologic DMARD as first-line therapy; 4. Trial and failure, intolerance, or contraindication to TWO of the following systemic/biologic agents: Cimzia; Enbrel; Humira (AbbVie), Hadlima, Simlandi, Yuflyma; Otezla/Otezla XR; Skyrizi; Sotyktu; Selarsdi, Steqeyma, Yesintek; Taltz; Tremfya.

Follow-up/authorization length per Limitations.

Initial Therapy - Psoriatic Arthritis

Covered when ALL of the following are met for Active Psoriatic Arthritis

Psoriatic Arthritis Initial Criteria: 1. Diagnosis of active psoriatic arthritis; 2. The member meets ONE of the following: actively inflamed joints; dactylitis; enthesitis; axial disease; or active skin and/or nail involvement; 3. Trial and failure, intolerance, or contraindication to TWO of the following agents: Cimzia; Enbrel; Humira (AbbVie), Hadlima, Simlandi, Yuflyma; Otezla/Otezla XR; Rinvoq/Rinvoq LQ; Simponi; Skyrizi; Selarsdi, Steqeyma, Yesintek; Taltz; Tremfya; Xeljanz/Xeljanz XR.

Initial Therapy - Ankylosing Spondylitis

Covered when ALL of the following are met for Active Ankylosing Spondylitis

Ankylosing Spondylitis Initial Criteria: 1. Diagnosis of active ankylosing spondylitis; 2. Minimum duration of 1-month trial and failure, contraindication, or intolerance to TWO different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses; 3. Trial and failure, intolerance, or contraindication to TWO of the following agents: Cimzia; Enbrel; Humira (AbbVie), Hadlima, Simlandi, Yuflyma; Rinvoq; Simponi; Taltz; Xeljanz/Xeljanz XR.

Initial Therapy - nr-axSpA

Covered when ALL of the following are met for Non-radiographic axial spondyloarthritis (nr-axSpA)

nr-axSpA Initial Criteria: 1. Diagnosis of active non-radiographic axial spondyloarthritis; 2. Member has objective signs of inflammation (e.g., CRP above the upper limit of normal and/or sacroiliitis on MRI); 3. Minimum 1-month duration trial and failure, contraindication, or intolerance to at least two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses; 4. Trial and failure, intolerance, or contraindication to TWO of the following agents: Cimzia; Rinvoq; Taltz.

Initial Therapy - Hidradenitis Suppurativa

Covered when ALL of the following are met for Hidradenitis Suppurativa

Hidradenitis Suppurativa Initial Criteria: 1. Member has a diagnosis of moderate to severe hidradenitis suppurativa (Hurley stage II or III); 2. Trial and failure, intolerance, or contraindication to ONE anti-TNF agent among the following adalimumab products: Humira (AbbVie), Hadlima, Simlandi, Yuflyma.

Continuation Therapy

Continuation of therapy (reauthorization)

Reauthorization Criteria: Submission of medical records (e.g., chart notes) demonstrating an improvement in the member's condition, evidenced by low disease activity or improvement in signs and symptoms of the condition.

Reauthorizations granted when improvement documented; approval length per Limitations.

This policy applies only to the pharmacy benefit. The medication is not covered under the medical benefit per policy language, and the medication has been designated as specialty and must be filled at a contracted specialty pharmacy.

Use of this medication is not supported when the required diagnosis-specific prior therapy trials have not been met and documented. Examples include failure to complete the minimum 4-week topical trial for plaque psoriasis or lack of documented trials/failures of required systemic/biologic agents for PsA, AS, nr-axSpA, or the required anti-TNF trial for hidradenitis suppurativa.

Key Clinical Thresholds and Coding-Related Metrics

inv-09: Body Surface Area — >= 3% BSA

Threshold>= 3% body surface area (BSA)

ContextApplied for determining moderate to severe plaque psoriasis in coverage criteria

Alternative qualifierInvolvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) may substitute for BSA threshold

inv-10: NSAID trial duration — minimum 1-month trial of two NSAIDs at maximally tolerated doses

Required durationMinimum 1-month trial of two different NSAIDs at maximally tolerated doses

Examples of NSAIDse.g., ibuprofen, naproxen

Prior Authorization, Documentation, and Operational Rules

Prior Authorization

Pharmacy prior authorization and specialty pharmacy fill required

Prior authorization is required through the pharmacy benefit and the medication must be filled at a contracted specialty pharmacy.

Step Therapy

Document required diagnosis‑specific prior therapy trials

Diagnosis-specific prior therapy trials must be documented before authorization: for plaque psoriasis a minimum 4-week topical trial (or first-line biologic if severe) plus trial and failure/intolerance/contraindication to two listed systemic/biologic agents; for psoriatic arthritis trial and failure/intolerance/contraindication to two listed agents; for ankylosing spondylitis and nr-axSpA a minimum 1-month trial and failure/intolerance/contraindication to two different NSAIDs at maximally tolerated doses followed by trial and failure/intolerance/contraindication to two listed biologic/other agents; for hidradenitis suppurativa trial and failure/intolerance/contraindication to one listed anti-TNF agent.

Plaque psoriasis: minimum 4-week trial of one topical agent (or severe disease qualifying for first-line biologic) AND trial and failure/intolerance/contraindication to TWO of the listed systemic/biologic agents (e.g., Cimzia, Enbrel, Humira/Hadlima/Simlandi/Yuflyma, Otezla/Otezla XR, Skyrizi, Sotyktu, Selarsdi/Steqeyma/Yesintek, Taltz, Tremfya).

Background on Bimzelx

Bimzelx (bimekizumab-bkzx) is an interleukin-17A and interleukin-17F antagonist approved for a range of immune-mediated conditions referenced in this policy, including moderate to severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis with objective signs of inflammation, and moderate to severe hidradenitis suppurativa. Authorization criteria in this policy are aligned to diagnosis-specific prior therapy requirements and objective measures of disease activity, and the medication must be obtained via the pharmacy benefit and filled through a contracted specialty pharmacy.

Definitions and Clinical Severity Thresholds

inv-18: Moderate to severe plaque psoriasis — Defined in policy as ≥3% body surface area affected OR involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin,...).

DefinitionModerate to severe plaque psoriasis defined as ≥3% body surface area affected OR involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Role in criteriaRequired diagnosis qualifier for initial therapy coverage of plaque psoriasis

Source sectionModerate to Severe Plaque Psoriasis (PsO) coverage criteria

inv-19: Objective signs of inflammation (nr-axSpA) — Examples include CRP above the upper limit of normal and/or sacroiliitis on MRI without definitive radiographic structural damage.

DefinitionObjective signs of inflammation include elevated C-reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on MRI without definitive radiographic structural damage

Policy Summary

PayerMass General Brigham Health Plan

PolicyBimzelx (bimekizumab-bkzx) prior authorization for indicated immune-mediated dermatologic and rheumatologic conditions

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical/coverage changes

Effective DateMay 1, 2026

Last ReviewMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization through the pharmacy benefit and ensure medication is dispensed via a contracted specialty pharmacy.

SourceLink

On This Page

Ankylosing spondylitis and non-radiographic axial spondyloarthritis initial therapy requirements

inv-11: Topical therapy trial duration — minimum 4-week trial

Required durationMinimum 4-week trial of a topical therapy

Acceptable topical agentsCorticosteroids, vitamin D analogs (calcitriol, calcipotriene), tazarotene, calcineurin inhibitors (tacrolimus, pimecrolimus), anthralin, coal tar

Applies toPlaque psoriasis initial therapy as one pathway before biologic therapy unless severe psoriasis warrants biologic first-line

Psoriatic arthritis: trial and failure/intolerance/contraindication to TWO of the listed agents (e.g., Cimzia, Enbrel, Humira/Hadlima/Simlandi/Yuflyma, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Simponi, Skyrizi, Selarsdi/Steqeyma/Yesintek, Taltz, Tremfya, Xeljanz/Xeljanz XR).

Ankylosing spondylitis and nr-axSpA: minimum 1-month trial and failure/intolerance/contraindication to TWO different NSAIDs at maximally tolerated doses, then trial and failure/intolerance/contraindication to TWO of the listed biologic/other agents.

Hidradenitis suppurativa: trial and failure/intolerance/contraindication to ONE anti-TNF agent among listed adalimumab products (Humira, Hadlima, Simlandi, Yuflyma).

Documentation Required

Submit medical records for new members and for continuation

For members new to the plan (coverage effective ≤ 90 days) submit medical records documenting the member is currently receiving the requested drug; for continuation requests submit medical records/chart notes demonstrating clinical improvement or low disease activity.

New-to-plan members: medical records showing current receipt of the requested drug (excluding samples or manufacturer patient assistance).
Continuation/reauthorization: chart notes demonstrating improvement or low disease activity per reauthorization criteria.

Denial Risk

Denial risk for not meeting diagnosis‑specific step criteria

Authorization may be denied if diagnosis‑specific step requirements are not met or documented, including lack of required topical, NSAID, or systemic/biologic trial(s) as specified per diagnosis, or absence of documentation for members new to the plan.

Denial risk if required topical trial (plaque psoriasis), NSAID trials (AS, nr-axSpA), or required biologic/DMARD/systemic agent trials (per diagnosis) are not met.
Denial risk if documentation demonstrating current therapy for members new to plan is not submitted.

Billing Rule

Use contracted specialty pharmacy and adhere to quantity limits

Denial may occur if the medication is not dispensed via a contracted specialty pharmacy or if quantity limits are exceeded (policy limits Bimzelx to 1 injection per 28 days).

This medication is designated specialty and must be filled at a contracted specialty pharmacy.
Quantity limit: Bimzelx autoinjector and prefilled syringe limited to 1 injection per 28 days.

Applies toNon-radiographic axial spondyloarthritis (nr-axSpA) initial therapy criteria

PurposeRequired as evidence of inflammatory disease for coverage determination

inv-20: Moderate to severe hidradenitis suppurativa — Policy references Hurley stage II or III as qualifying severity.

DefinitionModerate to severe hidradenitis suppurativa defined as Hurley stage II or III

Prior therapy requirementTrial and failure, intolerance, or contraindication to one anti-TNF agent (adalimumab products) is required

Source sectionHidradenitis suppurativa (HS) coverage criteria