WHA

Bimzelx (bimekizumab-bkzx)

Indications for Prior Authorization

Bimzelx (bimekizumab-bkzx)
  • For diagnosis of Plaque Psoriasis (PsO)
    Indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

  • For diagnosis of Psoriatic Arthritis (PsA)
    Indicated for the treatment of adult patients with active psoriatic arthritis.

  • For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)
    Indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

  • For diagnosis of Ankylosing Spondylitis (AS)
    Indicated for the treatment of adult patients with active ankylosing spondylitis.

  • For diagnosis of Hidradenitis Suppurativa (HS)
    Indicated for the treatment of adults with moderate to severe hidradenitis suppurativa.

Criteria

Bimzelx

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis

  • Diagnosis of moderate to severe plaque psoriasis
    • AND
  • One of the following [2]:
    • At least 3% body surface area involvement
    • Severe scalp psoriasis
    • Palmoplantar (i.e., palms, soles), facial, or genital involvement
    AND
  • Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies [3]:
    • corticosteroids (e.g., betamethasone, clobetasol)
    • vitamin D analogs (e.g., calcitriol, calcipotriene)
    • tazarotene
    • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
    AND
  • Prescribed by or in consultation with a dermatologist
    • AND
  • Trial and failure, contraindication, or intolerance to TWO of the following:
    • Cimzia (certolizumab pegol)
    • Enbrel (etanercept)
    • One formulary adalimumab product*
    • One formulary ustekinumab product*
    • Taltz (ixekizumab)
    • Skyrizi (risankizumab)
    • Tremfya (guselkumab)
    • Otezla (apremilast)
    • Sotyktu (deucravacitinib)
Bimzelx

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis

  • Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1-3]:
    • Reduction in the body surface area (BSA) involvement from baseline
    • Improvement in symptoms (e.g., pruritus, inflammation) from baseline
Bimzelx

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

  • Diagnosis of active psoriatic arthritis (PsA)
    • AND
  • One of the following [4]:
    • Actively inflamed joints
    • Dactylitis
    • Enthesitis
    • Axial disease
    • Active skin and/or nail involvement
    AND
  • Prescribed by or in consultation with one of the following:
    • Dermatologist
    • Rheumatologist
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following:
      • Cimzia (certolizumab pegol)
      • Enbrel (etanercept)
      • One formulary adalimumab product*
      • Simponi (golimumab)
      • One formulary ustekinumab product*
      • Taltz (ixekizumab)
      • Skyrizi (risankizumab)
      • Tremfya (guselkumab)
      • Rinvoq/LQ (upadacitinib)
      • Xeljanz/XR (tofacitinib/ER)
      OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Bimzelx

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

  • Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1, 4]:
    • Reduction in the total active (swollen and tender) joint count from baseline
    • Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
    • Reduction in the body surface area (BSA) involvement from baseline
Bimzelx

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)

  • Diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA)
    • AND
  • Patient has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints.) [1, 5]
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Minimum duration of one month trial and failure, contraindication, or intolerance to two different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen) at maximally tolerated doses [5]
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following:
      • Cimzia (certolizumab pegol)
      • Taltz (ixekizumab)
      • Rinvoq (upadacitinib)
      OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Bimzelx

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)

  • Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 5]:
    • Disease activity (e.g., pain, fatigue, inflammation, stiffness)
    • Function
    • Lab values (erythrocyte sedimentation rate, C-reactive protein level)
    • Axial status (e.g., lumbar spine motion, chest expansion)
    • Total active (swollen and tender) joint count
Bimzelx

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

  • Diagnosis of active ankylosing spondylitis (AS)
    • AND
  • Prescribed by or in consultation with a rheumatologist
    • AND
  • Minimum duration of one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses [5]
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following:
      • Cimzia (certolizumab pegol)
      • Enbrel (etanercept)
      • One formulary adalimumab product*
      • Simponi (golimumab)
      • Taltz (ixekizumab)
      • Rinvoq (upadacitinib)
      • Xeljanz/XR (tofacitinib/ER)
      OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Bimzelx

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

  • Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 5]:
    • Disease activity (e.g., pain, fatigue, inflammation, stiffness)
    • Function
    • Lab values (erythrocyte sedimentation rate, C-reactive protein level)
    • Axial status (e.g., lumbar spine motion, chest expansion)
    • Total active (swollen and tender) joint count
Bimzelx

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Hidradenitis Suppurativa (HS)

  • Diagnosis of moderate to severe hidradenitis suppurativa (i.e., Hurley Stage II or III) [1, 6]
    • AND
  • Prescribed by or in consultation with a dermatologist
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to one formulary adalimumab product*
      • OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Bimzelx

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Hidradenitis Suppurativa (HS)

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 6]:
    • Reduction in the abscess and inflammatory nodule count from baseline
    • Reduced formation of new sinus tracts and scarring
    • Improvement in symptoms (e.g., pain, suppuration) from baseline

  • Guideline ID
    GL-162993

  • Formulary
    premium

  • Effective date
    Mar 1, 2025

  • P&T approval date
    Dec 13, 2023

P & T Revisions

2025-01-15, 2024-12-01, 2024-11-27, 2024-09-15, 2024-06-24, 2024-05-30, 2024-04-24, 2024-04-04, 2024-03-07, 2023-11-30, 2023-06-30, 2023-05-03, 2023-02-01, 2022-10-23, 2022-05-07, 2021-04-23, 2020-09-18, 2020-06-10, 2019-10-31, 2019-09-26

  1. Bimzelx Prescribing Information. UCB, Inc. Smyrna, GA. November 2024.
  2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72.
  3. Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70.
  4. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
  5. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613.
  6. Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81(1):91-101.
  • 2025-01-15: Addition of criteria for HS; addition of 320 mg strength formulations
  • 2024-12-01: Addition of criteria for PsA, nr-axSpA, and AS. PsO - reduced step from triple to double with Otezla and Sotyktu added as preferred alternatives; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product"; removed NF criteria; added EHB formulary.
  • 2024-11-27: Addition of criteria for PsA, nr-axSpA, and AS. PsO - reduced step from triple to double with Otezla and Sotyktu added as preferred alternatives; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product"; removed NF criteria; added EHB formulary.
  • 2024-09-15: Removed anthralin and coal tar as topical step options for PsO
  • 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
  • 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
  • 2024-04-24: April 2024 - Addition of non-formulary criteria and records/claims requirements to embedded steps in PA criteria. March 2024 - Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2024-04-04: April 2024 - Addition of non-formulary criteria and records/claims requirements to embedded steps in PA criteria. March 2024 - Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2024-03-07: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2023-11-30: New program
  • 2023-06-30: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options
  • 2023-05-03: Annual review - no criteria changes
  • 2023-02-01: Addition of Amjevita as another preferred step option
  • 2022-10-23: Addition of Enbrel as an additional preferred step option; further clinical detail and criteria added
  • 2022-05-07: Annual review - no criteria changes
  • 2021-04-23: Annual review
  • 2020-09-18: Addition of objective measures to the psoriasis reauthorization criteria
  • 2020-06-10: Annual review - removed drug name from reauth criteria; references updates
  • 2019-10-31: Updated step requirement to a trial of 3 first line agents plus Taltz.
  • 2019-09-26: Annual Review; removed the restriction prohibiting use in combination with a biologic DMARD.