ModifiedUnitedHealthcarePolicy N/A

Bimzelx (bimekizumab-bkzx) prior authorization and medical necessity criteria

Defines UnitedHealthcare prior authorization and reauthorization clinical criteria for Bimzelx (bimekizumab-bkzx) across indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa for affected members and prescribers.

Policy Summary

PayerUnitedHealthcare

PolicyBimzelx (bimekizumab-bkzx) prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeMaterial updates to criteria, step therapy, and documentation

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with medical records documenting diagnosis and dates/durations of prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

Added criteria for hidradenitis suppurativa.

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

Added requirement for medical record submission for all authorization criteria.

Updated trial/failure criteria for Cosentyx and updated reference therapy steps including adding Sotyktu as a step agent for psoriasis.

UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes and/or claim logic.

12 monthsauthorization duration

HSindication added

medical records required

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documentation change

≥2 NSAIDsNSAID trial

Derm/Rheumprescriber specialty

Coverage Criteria by Indication

COVERAGE CRITERIA

Covered when ALL of the following are met:

Plaque psoriasis initial - overall

Disease extent: >=3% body surface area involvement OR palmoplantar, facial, genital, or severe scalp psoriasis
Topical therapy trial: History of failure, intolerance, or contraindication to at least one topical therapy (examples: corticosteroids, tazarotene, vitamin D analogs, calcineurin inhibitors, anthralin, coal tar) documented with date and duration
Systemic therapy trial or prior biologic: Either failure of a 3-month trial of methotrexate at maximally indicated dose unless contraindicated, OR prior treatment with an FDA‑approved targeted immunomodulator for plaque psoriasis documented by claims or medical records (document drug, date, and duration)3 months for methotrexate
Preferred agent failures: History of failure, contraindication, or intolerance to two of the listed preferred biologic products (document date and duration) or meeting alternative pathway via prior targeted immunomodulator use
Prescriber: Prescribed by or in consultation with a dermatologist
Patients established on therapy solely via manufacturer sample or UCB assistance must meet initial authorization criteria as if new to therapy

Reauthorization — Ankylosing Spondylitis

Reauthorization: Covered when ALL of the following are met

AS Reauth: Documentation of positive clinical response to Bimzelx therapy; AND patient is not receiving Bimzelx in combination with another targeted immunomodulator.N/A

Authorization will be issued for 12 months.

Reauthorization — Non-radiographic Axial Spondyloarthritis

Reauthorization: Covered when ALL of the following are met

nr-axSpA Reauth: Documentation of positive clinical response to Bimzelx therapy; AND patient is not receiving Bimzelx in combination with another targeted immunomodulator.N/A

Authorization will be issued for 12 months.

Initial and Reauthorization — Hidradenitis Suppurativa (HS)

Initial authorization: Covered when ALL of the following are met

HS Initial: (1) Diagnosis of moderate to severe hidradenitis suppurativa (Hurley Stage II or III); AND one of: (a) both: (i) history of failure to at least one oral antibiotic at maximally indicated doses unless contraindicated (document date and duration), AND (ii) history of failure/contraindication/intolerance to both of the specified preferred products (documented), OR (b) patient is currently on Bimzelx with claims/records and has not used manufacturer free samples/UCB assistance to establish current use; additional requirements: patient is not receiving Bimzelx in combination with another targeted immunomodulator and Bimzelx is prescribed by or in consultation with a dermatologist.N/A

Patients established via manufacturer sample/assistance must meet initial criteria as if new to therapy.

Reauthorization — Hidradenitis Suppurativa

Reauthorization: Covered when ALL of the following are met

HS Reauth: Documentation of positive clinical response to Bimzelx therapy; AND patient is not receiving Bimzelx in combination with another targeted immunomodulator.N/A

Authorization will be issued for 12 months.

If a patient was established on Bimzelx solely through receipt of a manufacturer‑supplied sample or any form of assistance from a UCB-sponsored program, the request for initial authorization must include the same documentation as for a new start. Provide medical records or claims history that meet all initial authorization requirements (diagnosis, prior therapy trials or documented prior biologic use, dates and durations). Manufacturer samples or assistance programs alone are not acceptable proof of prior or current therapy when requesting coverage.

Authorization for patients meeting initial criteria will be issued for 12 months when approved; documentation must clearly indicate whether manufacturer samples/UCB assistance were used to establish prior use.

Use of Bimzelx in combination with another targeted immunomodulator is not permitted and will result in denial. Examples of targeted immunomodulators include but are not limited to adalimumab, etanercept, certolizumab, golimumab, secukinumab, ixekizumab, risankizumab, guselkumab, tildrakizumab, tofacitinib, baricitinib, upadacitinib, and abatacept as listed in the policy.

Ensure the member is not receiving any concomitant targeted immunomodulator at the time of initial authorization or reauthorization; documentation should explicitly confirm absence of concurrent targeted biologic or JAK therapy.

Change control history documents iterative program updates. Recent entries note additions and removals to step therapy examples and references, inclusion of hidradenitis suppurativa criteria, and an added requirement that medical record submission is required for all authorization criteria. Notably, a prior notation of an exclusion was removed in a prior update; consult the change log for the effective dates of specific edits.

Continuation of Bimzelx without documentation of a positive clinical response is not supported. Reauthorization requires submission of medical records demonstrating treatment benefit and confirmation that the patient is not receiving Bimzelx in combination with another targeted immunomodulator.

For members already on therapy, provide claims history or medical records documenting dates and duration of Bimzelx use and whether manufacturer samples or assistance were used to establish therapy; absence of response documentation or evidence of concurrent targeted therapy may lead to denial.

Key Coding and Thresholds

Body surface area / NSAID trial duration — thresholds and trial requirements

Plaque psoriasis BSA threshold>=3% body surface area involvement OR palmoplantar, facial, genital, or severe scalp psoriasis

Ankylosing spondylitis NSAID requirementHistory of failure to two NSAIDs (e.g., ibuprofen, naproxen) at maximally indicated doses, each used for at least 4 weeks unless contraindicated

Documentation requirement for trialsDocument dates and duration of NSAID trials or BSA involvement/topical/systemic therapy trials in medical record for prior authorization

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Bimzelx. Providers must document an indication-specific diagnosis (e.g., plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, hidradenitis suppurativa) and meet the indication-specific criteria described in the policy. Authorization length when issued is typically 12 months unless otherwise specified.

Prior authorization required for all indications listed in the policy
Authorization typically issued for 12 months

Documentation Required

Documentation Required for Authorization

Providers must supply documentation that demonstrates the patient meets the indication-specific criteria (for initial or reauthorization). For initial requests this includes diagnosis, dates and durations of prior therapy trials, and documentation of failure, contraindication, or intolerance to required step therapies. For reauthorization, document positive clinical response to Bimzelx therapy.

Background and Drug Information

Bimzelx (bimekizumab‑bkzx) is a humanized interleukin‑17A and interleukin‑17F antagonist indicated for immune‑mediated conditions including moderate to severe plaque psoriasis, psoriatic arthritis, non‑radiographic axial spondyloarthritis, ankylosing spondylitis, and moderate to severe hidradenitis suppurativa. Its mechanism targets both IL‑17A and IL‑17F cytokines to reduce inflammatory activity in these conditions.

Clinical use and authorization in this policy are framed around documented diagnosis, prior therapy trials or prior targeted immunomodulator use, prescriber specialty requirements, and documented positive clinical response for reauthorization. Hidradenitis suppurativa is defined in the policy as Hurley Stage II or III when applicable.

Definitions and Terms

Bimzelx (bimekizumab-bkzx) — key drug identifiers

Drug name (generic)bimekizumab-bkzx

Drug name (brand)Bimzelx

Mechanism of actionHumanized interleukin-17A and interleukin-17F antagonist

Indications listed in policyModerate to severe plaque psoriasis; active psoriatic arthritis; nonradiographic axial spondyloarthritis; ankylosing spondylitis; moderate to severe hidradenitis suppurativa

Moderate to severe hidradenitis suppurativa — definition

Definition of moderate to severe HSDefined as Hurley Stage II or III

Authorization context

Policy Summary

PayerUnitedHealthcare

PolicyBimzelx (bimekizumab-bkzx) prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeMaterial updates to criteria, step therapy, and documentation

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with medical records documenting diagnosis and dates/durations of prior therapy trials.

SourceLink

On This Page

Document diagnosis and clinical indication (include ICD-10 where available)

Document dates and durations of prior topical, systemic, or biologic therapy trials

For reauthorization: documentation of positive clinical response

Denial Risk

Incomplete Documentation May Lead to Denial

If required documentation is missing or incomplete (for example: lack of diagnosis, absent dates or durations of prior therapy trials, or missing evidence of step therapy trials), the request may be denied. Ensure medical records or claims history substantiating prior therapies are submitted.

Missing diagnosis or clinical indication may trigger denial
Absent dates/durations for prior trials may trigger denial
Failure to submit medical records or claims history increases denial risk

Documentation Required

Manufacturer Samples / Assistance Not Acceptable as Proof

Manufacturer samples or manufacturer-sponsored assistance (e.g., free samples given in prescriber's office or sample cards redeemable at a pharmacy) are not acceptable proof that a member is an established user of Bimzelx. Members established on therapy via such samples or assistance must meet initial authorization criteria as if new to therapy; providers should supply standard documentation (prescriptions, medical records, claims history) to support ongoing use.

Manufacturer samples or UCB-sponsored program assistance do NOT count as proof of established therapy
Patients started via samples/assistance must meet initial authorization criteria
Submit medical records or claims history to substantiate prior use

Step Therapy

Step Therapy and Medication Sequencing

Step therapy and sequencing requirements vary by indication. Common requirements include documented trials of topical therapies and methotrexate (where applicable), and trial or documentation of prior targeted immunomodulators for certain indications. Providers must document failure, contraindication, or intolerance to required agents and preferred biologic products when specified.

Plaque psoriasis: trial/failure of topical agents and a 3-month trial of methotrexate at maximally indicated dose unless contraindicated, or prior use of a targeted immunomodulator
Psoriatic arthritis: 3-month methotrexate trial recommended unless contraindicated, or prior targeted immunomodulator
Axial spondyloarthritis/ankylosing spondylitis: failure of ≥2 NSAIDs (each ≥4 weeks) unless contraindicated, or prior targeted immunomodulator
Hidradenitis suppurativa: failure of at least one oral antibiotic at maximally indicated dose and failure/intolerance to specified preferred biologics

Step Therapy

Step Therapy Prerequisites (Examples)

Specific step therapy prerequisites examples: for axial disease (AS and nr-axSpA) document failure of two NSAIDs (e.g., ibuprofen, naproxen), each used for at least 4 weeks at maximally indicated doses unless contraindicated; for plaque psoriasis document topical therapy failures (list below) and a 3-month methotrexate trial unless contraindicated. When policy requires prior targeted immunomodulator use, document drug name, dates and duration.

Axial disease: ≥2 NSAIDs, each ≥4 weeks at maximally indicated dose (document dates/durations)
Plaque psoriasis topicals (document date and duration): corticosteroids, tazarotene, vitamin D analogs, calcineurin inhibitors, anthralin, coal tar
Methotrexate: 3-month trial at maximally indicated dose unless contraindicated (document date/duration)
When allowing prior targeted agents, document medication, dates, and duration (claims or medical records)

Step Therapy

Step Therapy Updates

Step therapy language has been updated over time. Recent updates include changes to preferred adalimumab product references, addition of Sotyktu as a step agent for plaque psoriasis, changes to ustekinumab (Stelara) language to 'one of the preferred ustekinumab products', and removal of specific example drugs in some steps. Refer to the policy Change Control section for the detailed revision history and current preferred-product language.

Added Sotyktu as a step agent for psoriasis
Changed 'Stelara' language to 'one of the preferred ustekinumab products'
Removed examples for adalimumab in step therapy (policy now references preferred products)

Documentation Required

Required Supporting Documentation

Required supporting documentation details: include dates and duration of prior medication trials, specific drug names (including preferred biologic products where required), documentation of contraindication or intolerance when applicable, and claims history or medical records showing prior targeted immunomodulator use. If the member is currently on Bimzelx, supply claims history, medical records, or manufacturer assistance documentation as applicable (samples/assistance alone are not sufficient).

List drug name, start and stop dates, and duration for each prior trial
For preferred biologics step: identify the specific preferred product(s) tried and durations
Provide medical records or claim history to substantiate prior therapies
If patient currently on Bimzelx: provide claims history or medical records; manufacturer assistance alone is insufficient

Documentation Required

Documentation for Patients Currently on Bimzelx

For patients already receiving Bimzelx, document current therapy via claim history or medical records. If the patient was started on Bimzelx through manufacturer samples or assistance, treat the request as an initial authorization and submit full initial-authorization documentation. Concurrent use of Bimzelx with another targeted immunomodulator is not permitted — document that no concurrent targeted immunomodulator is being used.

Current therapy: submit claims history or medical records showing ongoing Bimzelx use
Patients started via manufacturer samples/assistance must meet initial criteria
Concurrent targeted immunomodulators are not allowed; document absence of concurrent use

Note

Automated Approval Logic May Apply

UnitedHealthcare may use automated approval logic (claims/medication history and diagnosis codes) to approve initial or reauthorizations where the claims history and diagnosis codes satisfy policy rules. Supply complete claims/medical record evidence to support manual review when automated logic does not apply. Supply limits may apply.

Automated approval may be based solely on claim/medication history and ICD-10 diagnosis codes
Automated processes vary by program/therapeutic class
Supply limits may be enforced

Denial Risk

Denial Triggers and Common Reasons for Non-Approval

Common denial triggers include missing or incomplete documentation (no diagnosis, missing trial dates/durations), failure to meet step therapy requirements, evidence of concurrent use with other targeted immunomodulators, or reliance solely on manufacturer samples/assistance to establish prior use. Review the required documentation checklist before submission to reduce denial risk.

Missing diagnosis or inadequate documentation of indication
No dates or durations for prior therapy trials
Failure to meet step therapy prerequisites or required prior biologic trials
Concurrent use with another targeted immunomodulator
Using manufacturer samples/assistance as sole proof of established therapy

Diagnosis of moderate to severe hidradenitis suppurativa (Hurley Stage II or III) required for initial authorization

Prescriber requirementBimzelx must be prescribed by or in consultation with a dermatologist for HS indication

Bimzelx references — package insert and guideline sources

Package insertBimzelx [package insert]: Smyrna, GA: UCB, Inc; November 2024

Guideline reference — AAD-NPFMenter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics

Guideline reference — European S3Nast A, et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris 2015 (short version)