Cigna Bimzelx Prior Auth Policy Update

Coverage and Medical Necessity Criteria

Ankylosing Spondylitis

Covered when ONE of the following is met

Ankylosing Spondylitis - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is > 18 years of age; AND (ii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iii) according to the prescriber, the patient does not have moderately severe to severe depression; AND (iv) according to the prescriber, within the past 5 years the patient does not have a history of suicidal ideation or suicidal behavior; AND (v) the medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Bimzelx: Approve for 1 year if ALL of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iii) according to the prescriber, the patient does not have moderately severe to severe depression; AND (iv) according to the prescriber, the patient does not have suicidal ideation or suicidal behavior; AND (v) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Bimzelx); OR (b) compared with baseline (prior to initiating Bimzelx), patient experienced an improvement in at least one symptom, such as decreased pain or stiffness, or improvement in function or activities of daily living.

Examples of objective measures are listed in the policy (e.g., ASDAS, BASDAI, BASFI, serum markers).

Hidradenitis Suppurativa

Covered when ONE of the following is met

Hidradenitis Suppurativa - Initial or Continuation: A) Initial Therapy: Approve for 3 months if ALL of the following are met: (i) patient is ≥ 18 years of age; AND (ii) patient has tried at least one other therapy (examples include intralesional or oral corticosteroids, systemic antibiotics, isotretinoin); AND (iii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iv) according to the prescriber, the patient does not have moderately severe to severe depression; AND (v) according to the prescriber, within the past 5 years the patient does not have a history of suicidal ideation or suicidal behavior; AND (vi) the medication is prescribed by or in consultation with a dermatologist. OR B) Patient is Currently Receiving Bimzelx: Approve for 1 year if ALL of the following are met: (i) patient has been established on Bimzelx for at least 3 months; AND (ii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iii) according to the prescriber, the patient does not have moderately severe to severe depression; AND (iv) according to the prescriber, the patient does not have suicidal ideation or suicidal behavior; AND (v) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index); AND (vi) compared with baseline (prior to initiating Bimzelx), patient experienced an improvement in at least one symptom, such as decreased pain or drainage of lesions, nodules, or cysts.

Objective measure examples provided in policy.

Non-Radiographic Axial Spondyloarthritis

Covered when ONE of the following is met

Non-radiographic Axial Spondyloarthritis - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is > 18 years of age; AND (ii) patient has objective signs of inflammation, defined as at least ONE of: (a) C-reactive protein elevated beyond the upper limit of normal for the reporting laboratory; OR (b) sacroiliitis reported on magnetic resonance imaging; AND (iii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iv) according to the prescriber, the patient does not have moderately severe to severe depression; AND (v) according to the prescriber, within the past 5 years the patient does not have a history of suicidal ideation or suicidal behavior; AND (vi) the medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Bimzelx: Approve for 1 year if ALL of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iii) according to the prescriber, the patient does not have moderately severe to severe depression; AND (iv) according to the prescriber, the patient does not have suicidal ideation or suicidal behavior; AND (v) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Bimzelx); OR (b) compared with baseline (prior to initiating Bimzelx), patient experienced an improvement in at least one symptom, such as decreased pain or stiffness, or improvement in function or activities of daily living.

Objective signs of inflammation defined in policy (elevated CRP and/or MRI sacroiliitis).

Plaque Psoriasis

Covered when ONE of the following is met

Plaque Psoriasis - Initial or Continuation: A) Initial Therapy: Approve for 3 months if ALL of the following are met: (i) patient is ≥ 18 years of age; AND (ii) patient meets ONE of the following: (a) patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples include methotrexate, cyclosporine, acitretin; a 3-month trial of PUVA also counts); OR (b) according to the prescriber, the patient has a contraindication to methotrexate; AND (iii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iv) according to the prescriber, the patient does not have moderately severe to severe depression; AND (v) according to the prescriber, within the past 5 years the patient does not have a history of suicidal ideation or suicidal behavior; AND (vi) the medication is prescribed by or in consultation with a dermatologist. Note: An exception to the requirement for a trial of one traditional systemic agent can be made if the patient has already had a 3-month trial or prior intolerance to at least one biologic (other than the requested drug), Otezla/Otezla XR, or Sotyktu; a biosimilar of the requested biologic does not count. OR B) Patient is Currently Receiving Bimzelx: Approve for 1 year if ALL of the following are met: (i) patient has been established on therapy for at least 3 months; AND (ii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iii) according to the prescriber, the patient does not have moderately severe to severe depression; AND (iv) according to the prescriber, the patient does not have suicidal ideation or suicidal behavior; AND (v) patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of the following: estimated body surface area, erythema, induration/thickness, and/or scale of areas affected by psoriasis; AND (vi) compared with baseline (prior to receiving Bimzelx), patient experienced an improvement in at least one symptom, such as decreased pain, itching, and/or burning.

Biosimilars do not count as prior biologic trial.

Psoriatic Arthritis

Covered when ONE of the following is met

Psoriatic Arthritis - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (i) patient is > 18 years of age; AND (ii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iii) according to the prescriber, the patient does not have moderately severe to severe depression; AND (iv) according to the prescriber, within the past 5 years the patient does not have a history of suicidal ideation or suicidal behavior; AND (v) the medication is prescribed by or in consultation with a rheumatologist or a dermatologist. OR B) Patient is Currently Receiving Bimzelx: Approve for 1 year if ALL of the following are met: (i) patient has been established on therapy for at least 6 months; AND (ii) according to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy; AND (iii) according to the prescriber, the patient does not have moderately severe to severe depression; AND (iv) according to the prescriber, the patient does not have suicidal ideation or suicidal behavior; AND (v) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Bimzelx) (examples include DAPSA, CPDAI, PsA DAS, MDA, LEI, SPARCC, PsAID-12, and/or serum markers); OR (b) compared with baseline (prior to initiating Bimzelx), patient experienced an improvement in at least one symptom, such as less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; or decreased soft tissue swelling in joints or tendon sheaths.

Examples of standardized measures are listed in the policy.

Response/Continuation

Continuation/response criteria (as stated):

Continuation Criteria: Compared with baseline (prior to initiating Bimzelx), patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, or fatigue); improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths; or improvement in standardized disease activity measures (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument Score, MDA, PsAID-12) or serum markers (CRP, ESR).improvement vs baseline

Used to justify continuation of therapy.

Conditions Not Covered

Explicit not-covered uses:

Not Covered Conditions: Concurrent use with other biologics or with targeted synthetic oral small molecule drugs is considered not medically necessary; this does NOT exclude the use of conventional synthetic DMARDs in combination with Bimzelx. Inflammatory bowel disease (Crohn's disease, ulcerative colitis) is also considered not medically necessary due to exacerbations observed in clinical trials.N/A

Combination biologic/targeted synthetic therapy is not recommended due to safety and lack of supportive trial data; IBD exacerbations were observed in trials.

Requests for Bimzelx in combination with another biologic or a targeted synthetic oral small molecule drug for inflammatory conditions are considered not medically necessary and should not be administered concurrently. This operational exclusion reflects safety concerns and the absence of controlled trial data supporting additive efficacy when combining biologic or targeted synthetic therapies.

Concurrent use of Bimzelx with other biologic agents or with targeted synthetic oral small molecule drugs is excluded; however, this policy explicitly permits the use of conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) in combination with Bimzelx.

Use of Bimzelx for inflammatory bowel disease (Crohn's disease, ulcerative colitis) is considered not medically necessary. Clinical trials have reported exacerbations of inflammatory bowel disease, in some cases serious, among patients treated with Bimzelx, and therefore the agent is excluded for these indications.

Combination therapy with Bimzelx plus another biologic or a targeted synthetic oral small molecule drug for inflammatory conditions is prohibited. This policy-level exclusion is based on the potential for increased adverse effects and the lack of controlled clinical trial evidence demonstrating added benefit from combining these classes of therapies.

The policy lists several not medically necessary uses for Bimzelx: concurrent administration with other biologics or targeted synthetic oral small molecule drugs for inflammatory conditions, and use for inflammatory bowel disease (Crohn's disease, ulcerative colitis). Conventional synthetic DMARDs are not excluded and may be used concomitantly, but combinations with other biologic or targeted synthetic agents may be denied.

Coding and Age Thresholds

No codes present in this sectionmixed

No codes listed

Age thresholds — patient must be ≥18 years where specified

Age requirementPatient must be ≥18 years of age for indicated conditions (policy language: 'Patient is > 18 years of age' or 'Patient is ≥18 years' where specified).

Applies to initial therapyInitial therapy criteria across indications explicitly require the patient to be >18 years (examples: Ankylosing Spondylitis, Non‑radiographic Axial Spondyloarthritis, Psoriatic Arthritis).

Applies to plaque psoriasis and HSPlaque psoriasis and hidradenitis suppurativa initial-therapy criteria specify patient ≥18 years of age.

Therapy response assessment — improvement in at least one symptom or standardized measure

Continuation requirement — improvement vs baselineFor continuation, documentation must show improvement in at least one symptom or in a standardized disease activity measure compared with baseline (e.g., less joint pain, morning stiffness, fatigue; or improved DAPSA/CPDAI/PsA DAS/MDA/etc.).

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required. Approvals are issued for the durations specified in the policy (months = 30 days). Initial approvals require the medication to be prescribed by or in consultation with a clinician who specializes in the condition being treated.

Approvals: see FDA‑Approved Indications for condition‑specific durations.
Prescriber requirement: prescribed by or in consultation with a specialist in the condition being treated (e.g., rheumatologist for AS, dermatologist for HS/psoriasis).

Documentation Required

Prescriber Specialty and Treatment Response Documentation

For patients currently receiving therapy, prescriber must document ongoing assessment and treatment response. Documentation must include whether the prescriber evaluated risks of suicidal ideation or behavior versus benefits of therapy and attestation that the patient does not have moderately severe to severe depression or recent (within 5 years) history of suicidal ideation/behavior when required by the indication.

Background and Drug Overview

Bimzelx (bimekizumab-bkzx) is a subcutaneous biologic that inhibits interleukin‑17A and IL‑17F and is FDA‑approved for several inflammatory conditions including ankylosing spondylitis, non‑radiographic axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa. Refer to the prescribing information and the policy appendix for a complete list of approved indications and additional agent-specific details.

Definitions and Measurement Criteria

Objective signs of inflammation — definition (elevated CRP and/or sacroiliitis on imaging)

DefinitionObjective signs of inflammation are defined as elevated C‑reactive protein above the reporting laboratory's upper limit of normal and/or sacroiliitis reported on magnetic resonance imaging.

Context of useRequired for initial approval of non‑radiographic axial spondyloarthritis (policy states objective signs required in pivotal trial and in indication criteria).

How measuredCRP must be reported as above the lab's upper limit of normal; sacroiliitis must be identified on MRI reporting.

Bimzelx (bimekizumab-bkzx) — drug definition and FDA-approved indications summary

Agent descriptionBimzelx (bimekizumab‑bkzx) — a subcutaneous biologic that inhibits interleukin‑17A and interleukin‑17F (IL‑17A/17F).

OpenPayer

Bimzelx (bimekizumab) prior authorization

Coverage and Medical Necessity Criteria

Coding and Age Thresholds

Prior Authorization, Documentation, and Prescriber Requirements

Background and Drug Overview

Definitions and Measurement Criteria