CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy for Bimzelx (bimekizumab-bkzx)

Defines step therapy requirements for coverage of Bimzelx across multiple indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa) for members subject to UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Bimzelx (bimekizumab-bkzx)

Policy CodePolicy N/A

Change TypeMaterial updates to step therapy and preferred agents

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting failure, contraindication, or intolerance to two preferred agents (include drug name, dates, and duration).

SourceLink

POLICY UPDATE CHANGES

Added step therapy criteria for hidradenitis suppurativa.

Removed examples for adalimumab in step therapy and changed Stelara step to 'One of the preferred ustekinumab products'.

Decreased required step agents to two and added Sotyktu as a step therapy agent for plaque psoriasis.

5indications

2required failed agents

12auth duration (months)

Step Therapy

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Coverage Criteria — Indication-specific Initial Therapy

Initial therapy - Plaque Psoriasis

Plaque Psoriasis — Covered when ALL of the following are met

Plaque Psoriasis

Preferred agents list: One of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Skyrizi (risankizumab); Sotyktu (deucravacitinib); One of the preferred ustekinumab products; Tremfya (guselkumab)

Initial therapy - Psoriatic Arthritis

Psoriatic Arthritis — Covered when ALL of the following are met

Psoriatic Arthritis

Preferred agents list: 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)

Initial therapy - Ankylosing Spondylitis

Ankylosing Spondylitis — Covered when ALL of the following are met

Ankylosing Spondylitis

Preferred agents list: One of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Xeljanz/Xeljanz XR (tofacitinib)

Initial therapy - Non-radiographic Axial Spondyloarthritis

Non-radiographic Axial Spondyloarthritis — Covered when ALL of the following are met

nr-axSpA

Preferred agents list: Cimzia (certolizumab); Cosentyx (secukinumab); Rinvoq (upadacitinib)

Initial therapy - Hidradenitis Suppurativa

Hidradenitis Suppurativa — Covered when ALL of the following are met

Hidradenitis Suppurativa

Preferred agents list: One of the preferred adalimumab products; Cosentyx (secukinumab)

Other Diagnoses

Other Diagnoses: Bimzelx will be approved

No specific criteria provided in document.

Infused medications are explicitly excluded from the step therapy criteria for all conditions addressed by this policy. The program requires members to try preferred, non‑infused products (or document contraindication or intolerance) before Bimzelx will be approved; infused formulations are not considered part of those required trials. This exclusion applies across plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis, and hidradenitis suppurativa.

Initial Therapy Requirements and Definitions

Initial therapy requirements — documented failure, contraindication, or intolerance to specified preferred products per indication

Initial therapy coverage requires documented failure, contraindication, or intolerance to specified preferred products per indication.

Initial therapy: See indication-specific step lists for required failed preferred agents; document drug name, date, and duration of trial for each required agent.

Preferred product definition — formulary‑listed biologic/targeted therapy that must be tried and documented

DefinitionA formulary-listed biologic or targeted therapy that must be tried (and documented as failed, contraindicated, or intolerant) prior to coverage of Bimzelx under the step therapy program.

Required documentationDocument drug name, dates, and duration of trial for each preferred product tried (failure, contraindication, or intolerance).

Scope

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Step therapy prior authorization is required for Bimzelx. Approval is contingent on documentation showing failure, contraindication, or intolerance to the required number of specified preferred agents for the applicable diagnosis. Infused medications are excluded from the step-therapy requirement.

Authorization will be issued for 12 months.
State mandates and member-specific benefit plan coverage may impact criteria.
For a list of preferred products, reference drug coverage tools.

Step Therapy

Step Therapy Requirement

Step therapy requirement — members must try preferred, lower-cost alternatives before Bimzelx for the listed indications. Infused medications for any referenced conditions are not part of the criteria and do not satisfy the step requirement.

Plaque psoriasis: failure/contraindication/intolerance to two preferred agents (see list).

Step Therapy Rules and Preferred Alternatives

Indication	Step therapy requirement
Plaque psoriasis	History of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration of trial): One of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Skyrizi (risankizumab); Sotyktu (deucravacitinib); One of the preferred ustekinumab products; Tremfya (guselkumab). Authorization issued for 12 months.
Psoriatic arthritis	History of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration of trial): 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	History of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration of trial): One of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Xeljanz/Xeljanz XR (tofacitinib). Authorization issued for 12 months.
Non-radiographic axial spondyloarthritis (nr-axSpA)	History of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration of trial): Cimzia (certolizumab); Cosentyx (secukinumab); Rinvoq (upadacitinib).
Hidradenitis suppurativa (HS)	History of failure, contraindication, or intolerance to both of the following preferred products (document drug, date, and duration of trial): One of the preferred adalimumab products; Cosentyx (secukinumab).
Other diagnoses	No specific step criteria provided in document; coverage may be considered per policy and clinical review.

Continuation / Re-authorization

Re-authorization: Authorization will be issued for 12 months; re-authorization may be granted based on prior claim/medication history, diagnosis codes, and/or claim logic per UnitedHealthcare automated processes.

Site of Care — Infusion Exclusion

Note

Infused medications excluded from step requirements

Infused medications are excluded from the step criteria; only self-administered or otherwise approved non-infused formulations listed as preferred products count toward required trials.

Infused products for the referenced conditions do not satisfy the step therapy requirements.
Use the indication-specific preferred product lists for acceptable step agents.

Background — Drug and Program Context

Bimzelx (bimekizumab‑bkzx) is a humanized interleukin‑17A and IL‑17F antagonist approved for multiple immune‑mediated conditions. Per the policy background, it is indicated for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, for adults with active psoriatic arthritis, adults with active ankylosing spondylitis, and adults with active non‑radiographic axial spondyloarthritis with objective signs of inflammation, and for adults with moderate to severe hidradenitis suppurativa. The step therapy program described in this document uses these labeled indications and requires trials of preferred alternatives prior to approval of Bimzelx.