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.
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
- 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)
- 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
- Prescribed by or in consultation with one of the following:
- Dermatologist
- Rheumatologist
- 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)
- 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)
- 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)
- 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
P & T Revisions
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
References
- Bimzelx Prescribing Information. UCB, Inc. Smyrna, GA. October 2024.
- 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.
- 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.
- 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.
- 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.
Revision History
- 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.
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