ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 3181-4

Bimzelx® (bimekizumab-bkzx) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Step therapy program requiring trial/failure/contraindication/intolerance to specified preferred products before coverage of Bimzelx for listed indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, hidradenitis suppurativa, other diagnoses). Authorization terms and program-level rules apply.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBimzelx® (bimekizumab-bkzx) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3181-4

Change TypeStep therapy established and revised (multiple P&T updates)

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization required; document drug name, date, and duration of trials for preferred agents to satisfy step requirements; authorizations issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

New step therapy program created for Bimzelx (4/2024).

Updated step requirement noting specific preferred adalimumab products and removed preferred adalimumab footnote (10/2024).

Added step therapy criteria for hidradenitis suppurativa (1/2025).

Removed examples for adalimumab in step therapy and changed wording to 'One of the preferred ustekinumab products'; added footnote to reference drug coverage tools (4/2025).

5Indications with step criteria (PsO, PsA, AS, nr-axSpA, HS)

2Required failed agents per indication (typical)

12Authorization duration (months)

Coverage Summary

Step therapy program requiring trial/failure/contraindication/intolerance to specified preferred products before coverage of Bimzelx for listed indications: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa (other diagnoses considered per program rules). Infused medications are excluded from the step requirements. Authorization will be issued for 12 months.

Program summary

Indications with step criteria5

Required failed agents per indication2

Authorization duration12 months

Effective date2025-06-01

Last review2025-04

Initial Therapy Criteria

Plaque Psoriasis - Initial Approval Criteria

Bimzelx will be approved when ALL of the following are met:

ALL of the following

Member has diagnosis of moderate to severe plaque psoriasis and is a candidate for systemic therapy or phototherapy (implied by indication).
choose 2
- One of the preferred adalimumab products
- Cimzia (certolizumab)
- Cosentyx (secukinumab)

Provider Actions & Prior Authorization

Prior Authorization

Step therapy preauthorization required

Prior authorization is required. Member must have a documented history (drug name, date, and duration of trial) demonstrating failure, contraindication, or intolerance to the specified number of preferred agents for the indication. Authorization will be issued for 12 months.

Documentation Required

Document trials of preferred therapies

Document trials of preferred therapies used to satisfy step requirements. Record the drug name, date, and duration of each trial in the member’s medical record.

Applicable Codes

ICD-10 (diagnosis codes used for automated approval/reauthorization logic)ICD-10

No codes listed

Preferred biologic/small molecule step agents for plaque psoriasismixedCovered

adalimumab (preferred adalimumab products)	One of the preferred adalimumab products (see drug coverage tools for list)
certolizumab	Cimzia (certolizumab)
secukinumab	Cosentyx (secukinumab)
etanercept	Enbrel (etanercept)
risankizumab	Skyrizi (risankizumab)
deucravacitinib	Sotyktu (deucravacitinib)
ustekinumab (preferred ustekinumab products)	One of the preferred ustekinumab products (see drug coverage tools for list)
guselkumab	Tremfya (guselkumab)

Preferred biologic/small molecule step agents for psoriatic arthritismixedCovered

adalimumab (preferred adalimumab products)	One of the preferred adalimumab products (see drug coverage tools for list)
certolizumab	Cimzia (certolizumab)
secukinumab	Cosentyx (secukinumab)
etanercept	Enbrel (etanercept)
upadacitinib	Rinvoq (upadacitinib)
golimumab	Simponi (golimumab)
risankizumab	Skyrizi (risankizumab)
ustekinumab (preferred ustekinumab products)	One of the preferred ustekinumab products (see drug coverage tools for list)
guselkumab	Tremfya (guselkumab)
tofacitinib	Xeljanz/Xeljanz XR (tofacitinib)

Preferred biologic/small molecule step agents for ankylosing spondylitismixedCovered

adalimumab (preferred adalimumab products)	One of the preferred adalimumab products (see drug coverage tools for list)
certolizumab	Cimzia (certolizumab)
secukinumab	Cosentyx (secukinumab)
etanercept	Enbrel (etanercept)
upadacitinib	Rinvoq (upaditinib)
golimumab	Simponi (golimumab)
tofacitinib	Xeljanz/Xeljanz XR (tofacitinib)

Preferred biologic/small molecule step agents for non-radiographic axial spondyloarthritismixedCovered

certolizumab	Cimzia (certolizumab)
secukinumab	Cosentyx (secukinumab)
upadacitinib	Rinvoq (upadacitinib)

Preferred biologic/small molecule step agents for hidradenitis suppurativamixedCovered

adalimumab (preferred adalimumab products)	One of the preferred adalimumab products (see drug coverage tools for list)
secukinumab	Cosentyx (secukinumab)

Clinical Evidence & References

P&T approval dates: 4/2024, 10/2024, 1/2025, 4/2025. References: package inserts for Bimzelx and comparator agents as listed in the program references (e.g., Bimzelx [package insert] November 2024; Humira; Stelara; Cosentyx; Tremfya; Cimzia; Skyrizi; Enbrel; Otezla; Sotyktu).

Definition — Failure, contraindication, or intolerance: Member clinical history demonstrating lack of efficacy, documented contraindication, or inability to tolerate the medication; provider must document drug, date, and duration of trial.

Background

Step therapy requires trial of lower-cost preferred alternatives before coverage of Bimzelx; members must have documented history (drug, date, and duration) of failure, contraindication, or intolerance to the specified number of preferred agents for the indication.

Bimzelx is indicated for moderate to severe plaque psoriasis (in adults who are candidates for systemic therapy or phototherapy), active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation, active ankylosing spondylitis, and moderate to severe hidradenitis suppurativa.

Infused medications for any referenced conditions are not part of the step criteria (i.e., infused therapies are excluded from the step requirements).

Revision History

4/2024program_established

New step therapy program created for Bimzelx (Program established as Step Therapy; P&T approval 4/2024).

10/2024policy_updated

Updated step requirement adding Sotyktu as a step therapy agent for plaque psoriasis, decreased required step agents to two, noted specific preferred adalimumab products and removed the preferred adalimumab footnote (P&T approval 10/2024).

1/2025criteria_added

Added step therapy criteria for hidradenitis suppurativa requiring failure/intolerance to two specified agents (P&T approval 1/2025).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBimzelx® (bimekizumab-bkzx) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3181-4

Change TypeStep therapy established and revised (multiple P&T updates)

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization required; document drug name, date, and duration of trials for preferred agents to satisfy step requirements; authorizations issued for 12 months.

SourceLink

On This Page

Skyrizi (risankizumab)

Sotyktu (deucravacitinib)

One of the preferred ustekinumab products

Tremfya (guselkumab)

Psoriatic Arthritis - Initial Approval Criteria

Bimzelx will be approved when ALL of the following are met:

ALL of the following

Member has diagnosis of active psoriatic arthritis (implied by indication).
choose 2
- One of the preferred adalimumab products
- Cimzia (certolizumab)
- Cosentyx (secukinumab)
- Enbrel (etanercept)
- Rinvoq (upadacitinib)
- Simponi (golimumab)
- Skyrizi (risankizumab)
- One of the preferred ustekinumab products
- Tremfya (guselkumab)
- Xeljanz/Xeljanz XR (tofacitinib)

Ankylosing Spondylitis - Initial Approval Criteria

Bimzelx will be approved when ALL of the following are met:

ALL of the following

Member has diagnosis of active ankylosing spondylitis (implied by indication).
choose 2
- One of the preferred adalimumab products
- Cimzia (certolizumab)
- Cosentyx (secukinumab)
- Enbrel (etanercept)
- Rinvoq (upadacitinib)
- Simponi (golimumab)
- Xeljanz/Xeljanz XR (tofacitinib)

Non-radiographic Axial Spondyloarthritis - Initial Approval Criteria

Bimzelx will be approved when ALL of the following are met:

ALL of the following

Member has diagnosis of active non-radiographic axial spondyloarthritis with objective signs of inflammation (implied by indication).
choose 2
- Cimzia (certolizumab)
- Cosentyx (secukinumab)
- Rinvoq (upadacitinib)

Hidradenitis Suppurativa (HS) - Initial Approval Criteria

Bimzelx will be approved when ALL of the following are met:

ALL of the following

Member has diagnosis of moderate to severe hidradenitis suppurativa (implied by indication).
ALL of the following
- One of the preferred adalimumab products
- Cosentyx (secukinumab)

Other Diagnoses - Initial Approval Notes

Bimzelx will be approved for other diagnoses per program rules.

Other diagnoses: Authorization may be granted (no additional criteria specified in document).

Billing Rule

Infused medications exclusion from criteria

Infused medications referenced in this document are excluded from the step therapy criteria and are not counted as step agents; step agents are the non-infused biologics/small molecules listed in the criteria.

Denial Risk

Automated denial/approval logic

UnitedHealthcare may use prior claim/medication history, diagnosis codes (ICD-10), and claim logic to automatically approve or reauthorize. Absence of documented trials (drug, date, duration) may lead to denial if automated/claims logic does not support prior use.

4/2025clarificationLatest

Clarified preferred product listing: removed examples for adalimumab, changed wording to 'One of the preferred ustekinumab products', and added a footnote referencing external drug coverage tools (P&T approval 4/2025).