CurrentColorado Rocky Mountain Health PlansPolicy N/A

Bimzelx (bimekizumab) prior authorization criteria

Defines UnitedHealthcare prior authorization and reauthorization clinical criteria for Bimzelx (bimekizumab) for multiple indications (psoriasis, psoriatic arthritis, ankylosing spondylitis/axial spondyloarthritis, hidradenitis suppurativa) and who may prescribe.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBimzelx (bimekizumab) prior authorization criteria

Policy CodePolicy N/A

Change TypeMaterial clinical and step therapy updates (HS criteria addedstep revisionsdocumentation requirement)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionDocument prior therapy and current Bimzelx use with claims or medical records when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Added criteria for hidradenitis suppurativa.

Updated step requirement noting specific preferred adalimumab products and added Sotyktu as step therapy agent for psoriasis; changed number of step requirement to two and added continuation of care if already on Bimzelx.

Added requirement for medical record submission for all authorization criteria and updated trial/failure criteria for Cosentyx.

12 monthsauth duration

2 NSAIDs ≥4wksnr-axSpA step

Hurley II/IIIHS severity

Yes

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

nr-axSpA Initial Therapy

Covered when ALL of the following are met

nr-axSpA initial: (1) Diagnosis of active non-radiographic axial spondyloarthritis;

nr-axSpA initial

ONE of: (a) History of failure to two NSAIDs (e.g., ibuprofen, naproxen) at maximally indicated doses, each used for at least 4 weeks unless contraindicated or clinically significant adverse effects are experienced (document drug, date, and duration of trials).
ONE of: (b) Patient has been previously treated with a targeted immunomodulator FDA‑approved for the treatment of non‑radiographic axial spondyloarthritis as documented by claims history or submission of medical records (document drug, date and duration of therapy) [e.g., Cimzia (certolizumab), Cosentyx (secukinumab), Rinvoq (upadacitinib)].

nr-axSpA initial

ONE of: (a) 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).
ONE of: (b) Patient is currently on Bimzelx therapy as documented by claims history or submission of medical records (document date and duration of therapy) and has not received a manufacturer supplied sample or UCB‑sponsored assistance as a means to establish current use.

nr-axSpA initial: (4) Patient is not receiving Bimzelx in combination with another targeted immunomodulator (e.g., Enbrel, Cimzia, Cosentyx, Simponi, Orencia, adalimumab, Xeljanz, Olumiant, Rinvoq).

nr-axSpA initial: (5) Prescribed by or in consultation with a rheumatologist.

nr-axSpA Reauthorization

Covered when BOTH of the following are met

nr-axSpA reauth: (1) Documentation of positive clinical response to Bimzelx therapy;

nr-axSpA reauth: (2) Patient is not receiving Bimzelx in combination with another targeted immunomodulator (e.g., Enbrel, Simponi, Orencia, adalimumab, Xeljanz, Olumiant, Rinvoq). Authorization will be issued for 12 months.

AS/axSpA Initial Therapy

Covered when ALL of the following are met

AS/axSpA initial: (1) Diagnosis of ankylosing spondylitis or axial spondyloarthritis as specified elsewhere in the policy;

AS/axSpA initial

ONE of: (a) History of failure, contraindication, or intolerance to two preferred products (document drug, date, and duration of trial) from the following list: adalimumab products, Cimzia (certolizumab), Cosentyx (secukinumab), Enbrel (etanercept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz (tofacitinib).
ONE of: (b) Patient is currently on Bimzelx therapy as documented by claims history or submission of medical records (document date and duration of therapy) and has not received a manufacturer supplied sample or UCB‑sponsored assistance to establish use.

AS/axSpA initial:

Hidradenitis Suppurativa Initial Therapy

Covered when ALL of the following are met

HS initial: (1) Diagnosis of moderate to severe hidradenitis suppurativa (Hurley Stage II or III);

HS initial

ONE of: (a) Both of the following: (i) History of failure to at least one oral antibiotic (e.g., doxycycline, clindamycin, rifampin) at maximally indicated doses unless contraindicated (document drug, date, and duration of trial); AND (ii) History of failure, contraindication, or intolerance to both preferred products (document drug, date, and duration of trial): one of the preferred adalimumab products and Cosentyx (secukinumab).
ONE of: (b) Patient is currently on Bimzelx therapy as documented by claims history or submission of medical records (document date and duration of therapy) and has not received a manufacturer supplied sample or UCB‑sponsored assistance to establish use.

Reauthorization — All Indications

Covered when ALL of the following are met

General reauth: (1) Documentation of positive clinical response to Bimzelx therapy;

General reauth: (2) Patient is not receiving Bimzelx in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia, Cosentyx, Enbrel, Olumiant, Orencia, Simponi, Rinvoq, Xeljanz). Authorization will be issued for 12 months.

Coverage of Bimzelx (bimekizumab) is subject to state and federal requirements and to the member’s specific benefit plan. State mandates, any applicable federal regulatory requirements, and the member’s benefit coverage may limit or modify coverage determinations. Additionally, other policies and utilization management programs (for example, preferred product lists and supply limits) may apply and affect authorization decisions.

Coding and Trial Durations

NSAID trial duration

NSAID trial durationEach NSAID must be used for at least 4 weeks at maximally indicated doses unless contraindicated or clinically significant adverse effects occur (document drug, date, and duration).

Example NSAIDsIncludes agents such as ibuprofen and naproxen as cited in policy examples.

Documentation requiredDocument drug name, start and end dates, and duration of each NSAID trial in the medical record or claims history.

ExceptionShorter duration allowed if contraindication or clinically significant adverse effect is experienced, with documentation.

Provider Actions and Operational Requirements

Prior Authorization

Indication-specific initial authorization

Indication-specific initial authorization — initial requests must include diagnosis-specific documentation (for example: active non-radiographic axial spondyloarthritis, moderate-to-severe plaque psoriasis, hidradenitis suppurativa). For each indication, include documentation of the diagnosis and any required prior therapies, dates, and durations.

Step Therapy

Many indications require prior failure

Prior failure/contraindication/intolerance requirements — many indications require documentation of prior failure, contraindication, or intolerance to specified preferred products or classes (e.g., failure of two NSAIDs for non‑radiographic axial spondyloarthritis; failure of specified biologics such as Cimzia, Cosentyx, or Rinvoq where listed). Include drug name, dates, and duration of each trial.

Documentation Required

Definitions

Established user via sample

DefinitionPatients who began Bimzelx therapy via manufacturer‑supplied free samples or assistance programs are considered new to therapy and must meet initial authorization criteria as if newly starting treatment.

Policy consequenceEstablished use based on samples does not qualify a patient for continuation-of-care; initial criteria including prior therapy requirements must be met.

DocumentationProviders must submit claims history or medical records to document prior Bimzelx use; absence of such documentation means patient must meet initial authorization criteria.

Examples of assistanceIncludes sample cards redeemable at a pharmacy or any form of assistance from a UCB‑sponsored program used to establish current use.

Background

Bimzelx (bimekizumab) is approved for multiple immune-mediated conditions and is included in this policy with indication-specific prior authorization criteria. Coverage criteria vary by diagnosis and typically require documentation of the indicated diagnosis, prior therapy trials or documented current use, and that the patient is not receiving Bimzelx in combination with another targeted immunomodulator. When approved, authorizations are issued for 12 months unless otherwise specified; note that certain states or lines of business may have alternate requirements (for example, a 30-day trial for Connecticut, Kentucky, and Mississippi business).