CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Bimzelx (bimekizumab) — Coverage Criteria for Plaque Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, Ankylosing Spondylitis, and Hidradenitis Suppurativa

Defines medical necessity, authorization durations, dosing, quantity limits, and documentation requirements for Bimzelx for adults with plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (including nr-axSpA and AS), and hidradenitis suppurativa for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBimzelx (bimekizumab) — Coverage Criteria for PsO, PsA, nr-axSpA, AS, HS

Policy CodePolicy N/A

Change TypeNew coverage criteria and dosing guidance added

Effective DateMay 1, 2024

Next Review DateFeb 1, 2025

Key ActionSubmit the member's chart or medical record documenting indication-specific criteria, prior therapy trials, TB test if biologic-naive, and specialist consultation.

SourceLink

POLICY UPDATE CHANGES

Bimzelx indications list (PsO, PsA, nr-axSpA, AS, HS) and associated approval criteria are included.

Dose schedules and dosing modification guidance (including weight-based 4-week maintenance for ≥120 kg) are specified.

Quantity limits and exceptions for induction and maintenance regimens are defined.

5covered indications listed

4 moplaque PsO init auth

6 mo

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Coverage Criteria and Authorization Durations

Initial Therapy — Plaque Psoriasis

Covered when ALL of the following are met for plaque psoriasis initial authorization (4 months):

Plaque Psoriasis Initial Authorization: Member is >=18 years; prescribed by or in consultation with a dermatologist; documentation that at least 10% body surface area (BSA) is affected or involvement is documented as crucial; inadequate response or intolerance to at least a 3-month trial of methotrexate, cyclosporine, or acitretin; inadequate response to at least a 3-month trial of phototherapy (UVB or PUVA) unless intolerant; inadequate response, intolerance, or contraindication to at least one additional systemic or biologic psoriasis medication (examples include roflumilast, etanercept, secukinumab, risankizumab, infliximab products, tildrakizumab, guselkumab, or apremilast) OR inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses.age >=18

Authorization of 4 months may be granted.

Initial Therapy — Psoriatic Arthritis

Covered when ALL of the following are met for psoriatic arthritis initial authorization (6 months):

Psoriatic Arthritis Initial Authorization: Bimzelx prescribed by or in consultation with dermatology or rheumatology; documented moderate to severe active disease; if peripheral arthritis, inadequate response to a 2–3 month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine) unless intolerant; if predominantly axial disease or active enthesitis/dactylitis, inadequate response or intolerance to at least two NSAIDs unless contraindicated; inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses.

Authorization of 6 months may be granted.

Initial Therapy — Non-Radiographic Axial Spondyloarthritis

Covered when ALL of the following are met for non-radiographic axial spondyloarthritis (nr-axSpA) initial authorization (6 months):

nr-axSpA Initial Authorization: Prescribed by or in consultation with dermatology or rheumatology; documented active disease without definitive radiographic sacroiliac structural damage; objective signs of inflammation (elevated CRP and/or sacroiliitis on MRI); inadequate response or contraindication to two NSAIDs; 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.

Initial Therapy — Ankylosing Spondylitis

Covered when ALL of the following are met for ankylosing spondylitis initial authorization (6 months):

Ankylosing Spondylitis Initial Authorization: Bimzelx prescribed by or in consultation with rheumatology; member >=18 years; documented active disease; inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; inadequate response or intolerance to at least two NSAIDs over a total of 4 weeks unless contraindicated.

Authorization of 6 months may be granted.

Initial Therapy — Hidradenitis Suppurativa

Covered when ALL of the following are met for hidradenitis suppurativa initial authorization (6 months):

Hidradenitis Suppurativa Initial Authorization: Prescribed by or in consultation with a dermatologist; member >=18 years; documented moderate to severe hidradenitis suppurativa; inadequate response to oral antibiotics for at least 90 days or intolerance/contraindication to oral antibiotics; inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab at maximum tolerated doses.

Authorization of 6 months may be granted.

Continuation / Maintenance Response Criteria

Continuation/renewal authorization (12 months) criteria — covered when ANY of the following improvements from baseline are documented, depending on indication:

Psoriasis Continuation Criteria: Improvement in body surface area (BSA) affected from baseline OR improvement in signs and symptoms (e.g., itching, redness, flaking, scaling, burning, cracking, pain). If request is for every-4-week dosing, provider must submit medical rationale including current weight after at least 16 weeks and show clinically meaningful incremental benefit over every-8-week dosing.

Authorization of 12 months may be granted.

Psoriatic Arthritis Continuation Criteria: Improvement in number of swollen joints OR number of tender joints OR dactylitis OR enthesitis OR skin and/or nail involvement OR meeting PsARC response (one of joint tenderness or swelling and no worsening in other criteria).

Authorization of 12 months may be granted.

nr-axSpA Continuation Criteria: Improvement in total back pain OR physical function OR disease activity scoring tool (e.g., >=1.1 improvement in ASDAS or >=2 improvement in BASDAI) OR reduction in C-reactive protein (CRP).

All indications for Bimzelx (bimekizumab) that are not explicitly listed in this policy — beyond the EDA‑approved and compendial uses of plaque psoriasis (PsO), psoriatic arthritis (PsA), non‑radiographic axial spondyloarthritis (nr‑axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS) — are considered experimental/investigational and not medically necessary.

Use of Bimzelx for diagnoses or indications other than the specified FDA/EDA‑approved and compendial uses listed in this policy is considered not medically necessary and will not be covered.

Prior Authorization, Documentation, and Prescribing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation of Bimzelx (bimekizumab-bkzx). Initial authorizations may be granted for 4 months for plaque psoriasis and 6 months for other covered indications (Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Hidradenitis Suppurativa) when all indication-specific criteria are met. Authorization requests lacking required documentation may be denied or returned for more information.

Initial authorization: 4 months for plaque psoriasis; 6 months for PsA, AS, nr-axSpA, HS
Prescriber requirement: prescribed by or in consultation with an appropriate specialist (dermatology for PsO and HS; dermatology or rheumatology for PsA and nr-axSpA; rheumatology for AS)
Submit member chart or medical record documentation supporting all applicable criteria

Documentation Required

Documentation Requirements and Concomitant Therapy Restrictions

Submit the member's chart or medical record to document medical necessity. Required documentation includes specialist consultation notes, baseline disease severity measures (e.g., BSA for psoriasis, CRP or MRI for nr-axSpA), prior therapy details (drug name, dose, duration, reason for discontinuation), TB screening results when applicable, and any other records that demonstrate the member meets the indication-specific criteria. Requests with incomplete or missing documentation may be denied.

Dosing, Quantity Limits, and Weight-Based Considerations

inv-09: Weight threshold for dosing escalation

Weight threshold>= 120 kg

Dosing implicationFor members >= 120 kg, consider 320 mg subcutaneously every 4 weeks after the 16-week induction period for plaque psoriasis

Timing for escalationEscalation to every-4-week maintenance should be considered after at least 16 weeks of therapy

Screening and Prescriber Requirements

inv-15: TB screening

RequirementDocumented negative TB test (PPD, IGRA, or chest X-ray) within 6 months prior to initiating therapy for patients naive to biologic or targeted synthetic agents

Test types acceptedTuberculosis skin test (PPD), interferon-gamma release assay (IGRA), or chest X-ray

Applies toPatients who are naive to biologic or targeted synthetic drugs associated with increased TB risk

inv-16: Specialist prescriber

Primary requirementBimzelx must be prescribed by, or in consultation with, an appropriate specialist

DermatologyRequired prescriber or consultant for plaque psoriasis and hidradenitis suppurativa

Drug Background and Indications

Bimzelx (bimekizumab) is a biologic indicated for use in adults for multiple immune‑mediated inflammatory conditions. The EDA‑approved indications covered by this policy include moderate to severe plaque psoriasis (PsO) in adults who are candidates for systemic therapy or phototherapy, and the treatment of adults with active psoriatic arthritis (PsA), non‑radiographic axial spondyloarthritis (nr‑axSpA) with objective signs of inflammation, ankylosing spondylitis (AS), and moderate to severe hidradenitis suppurativa (HS).

Policy Changes and Effective Dates

2024-05-01policy_effectiveLatest

Policy effective date established and comprehensive coverage criteria for Bimzelx (bimekizumab) across five indications (plaque psoriasis, psoriatic arthritis, non‑radiographic axial spondyloarthritis, ankylosing spondylitis, hidradenitis suppurativa) were added.

2024-05-01dosing_update

Dosing schedules and induction/maintenance regimens were specified for each indication, including note that members >=120 kg may be considered for every‑4‑week 320 mg maintenance dosing after induction.

2024-05-01

Step Therapy

Required Prior Therapy Trials

Prior therapy trials are required and must be documented in the medical record. If the member has inadequate response, intolerance, or contraindication to required prior therapies, document the reason(s). Specific prior therapy requirements vary by indication as noted below.

Plaque psoriasis: documentation of ≥10% BSA OR other crucial involvement, plus inadequate response to at least one 3-month trial of methotrexate, cyclosporine, or acitretin (or intolerance). Also inadequate response to a 3-month trial of phototherapy unless intolerant, and inadequate response/intolerance/contraindication to at least one additional systemic or biologic psoriasis therapy (examples: roflumilast, etanercept, secukinumab, risankizumab, infliximab products, tildrakizumab, guselkumab, apremilast). Also requires inadequate response to a 3-month trial of adalimumab and a 6-month trial of ustekinumab biosimilar at maximum tolerated doses when specified.
Psoriatic arthritis: inadequate response to a 2–3 month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine) for peripheral arthritis, or inadequate response/intolerance to ≥2 NSAIDs for axial disease/enthesitis/dactylitis. Also requires inadequate response/intolerance/contraindication to a 3-month trial of adalimumab and a 6-month trial of ustekinumab biosimilar at maximum tolerated doses when specified.
Ankylosing spondylitis (AS): inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses, and inadequate response or intolerance to ≥2 NSAIDs over a total of 4 weeks unless contraindicated.
Non-radiographic axial spondyloarthritis (nr-axSpA): inadequate response or contraindication to two NSAIDs, and inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses. Also requires objective signs of inflammation (elevated CRP and/or sacroiliitis on MRI) and absence of definitive radiographic structural damage of the sacroiliac joints.
Hidradenitis suppurativa (HS): inadequate response to oral antibiotics for ≥90 days (or intolerance/contraindication), inadequate response/intolerance/contraindication to a 3-month trial of adalimumab at maximum tolerated doses, and inadequate response/intolerance/contraindication to a 6-month trial of ustekinumab at maximum tolerated doses when specified.
Across indications: Bimzelx must not be used concomitantly with other injectable biologic response modifiers (e.g., TNF inhibitors, IL inhibitors) or with certain oral non-biologic systemic agents (e.g., apremilast, tofacitinib, baricitinib, upadacitinib) unless explicitly documented as rationale for combination or exception.