CurrentCignaPolicy N/A

Inflammatory Conditions - Bimzelx Drug Quantity Management Policy - Per Days

Defines quantity limits, override criteria, and coverage rules for Bimzelx subcutaneous injections for Cigna-administered health benefit plans; applies to retail and home delivery dispensing and impacts prescribing providers and pharmacy benefit administrators.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Bimzelx Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeQuantity limits and induction overrides revised

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation verifying absence of prior Bimzelx claims in the past 130 days to support one-time induction override requests.

SourceLink

POLICY UPDATE CHANGES

Override criteria for initiation/induction dosing for plaque psoriasis updated to approve a one-time override for 8 mL for 112 days at retail or home delivery (previously 4 mL per 56 days for total 112 days).

Override criteria for initiation/induction dosing for hidradenitis suppurativa updated to approve a one-time override for 16 mL for 112 days at retail or home delivery (previously 8 mL per 56 days).

Quantity limit established as 2 mL per 56 days for Bimzelx (both 160 mg/1 mL and 320 mg/2 mL presentations).

Dose-for-weight override for patients ≥120 kg who require 320 mg every 4 weeks applies specifically to plaque psoriasis.

References to number of syringes/auto-injectors were removed from override criteria documentation.

2 mLstandard maximum quantity per 56 days

8 mLone-time induction override for plaque psoriasis (112 days)

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Coverage Criteria & Overrides

Quantity Limit Exceptions / Override Criteria

Exceptions to the baseline quantity limits are approved as medically necessary when the following specific criteria are met.

Baseline: Standard quantity limit: 2 mL per 56 days for Bimzelx (both 160 mg/1 mL and 320 mg/2 mL presentations).2 mL per 56 days

Applies to retail or home delivery.

Plaque psoriasis initiation/induction override: If the patient is initiating treatment with Bimzelx for plaque psoriasis or requires additional induction dosing for plaque psoriasis, and absence of claims for Bimzelx in the past 130 days is verified, approve a one-time override of 8 mL for 112 days at retail or home delivery.absence of claims in past 130 days

Provides four 320 mg doses (320 mg once every 4 weeks at Weeks 0,4,8,12).

Plaque psoriasis weight-based dosing override: If the patient weighs ≥ 120 kg and requires a dose of 320 mg once every 4 weeks for plaque psoriasis, approve 2 mL per 28 days at retail or 6 mL per 84 days at home delivery.>= 120 kg

Applies to plaque psoriasis only.

Hidradenitis suppurativa initiation/induction override: If the patient is initiating treatment with Bimzelx for hidradenitis suppurativa or requires additional induction dosing for hidradenitis suppurativa, and absence of claims for Bimzelx in the past 130 days is verified, approve a one-time override of 16 mL for 112 days at retail or home delivery.absence of claims in past 130 days

Provides eight 320 mg doses (320 mg once every 2 weeks at Weeks 0,2,4,6,8,10,12,14).

Hidradenitis suppurativa maintenance: If the patient is treating hidradenitis suppurativa, approve 2 mL per 28 days at retail or 6 mL per 84 days at home delivery.none

Maintenance dispensing cadence defined.

Exceptions to the baseline dispensing maximum are allowed only as specified in the policy. Specifically, exceptions to the quantity limits listed above are covered as medically necessary when the following criteria are met. Any other exception is considered not medically necessary.

The policy establishes a Drug Quantity Management rule for Bimzelx. Requests that exceed the stated quantity limits without meeting one of the specified override criteria are considered not medically necessary. Coverage is limited to the quantity limits and the explicit exceptions enumerated in the policy.

Induction / Initial Therapy Overrides

Initial Therapy Overrides

Induction/initial dosing and overrides

Plaque psoriasis initiation: Absence of Bimzelx claims in the past 130 days verifies initiation; a one-time override of 8 mL for 112 days may be approved to supply induction dosing (provides four 320 mg doses at Weeks 0,4,8,12).absence of claims in past 130 days

Retail or home delivery.

Hidradenitis suppurativa initiation: Absence of Bimzelx claims in the past 130 days verifies initiation; a one-time override of 16 mL for 112 days may be approved to supply induction dosing (provides eight 320 mg doses at Weeks 0,2,4,6,8,10,12,14).absence of claims in past 130 days

Retail or home delivery.

Quantity Limits and Maintenance Dosing

Bimzelx presentations — standard maximum quantity per 56 days (2 mL)

Standard maximum quantity2 mL per 56 days for Bimzelx (160 mg/1 mL and 320 mg/2 mL presentations)

Applies toRetail or home delivery dispensing

Formulations referencedAuto-injectors and prefilled syringes (160 mg/1 mL and 320 mg/2 mL)

Bimzelx induction override for plaque psoriasis — one-time 8 mL for 112 days

One-time induction override (plaque psoriasis)8 mL approved for 112 days (one-time) when initiating Bimzelx for plaque psoriasis or requiring additional induction dosing, verified by absence of Bimzelx claims in the past 130 days

Dose providedQuantity sufficient for four 320 mg doses at Weeks 0, 4, 8, and 12

Dispensing Settings

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are for a specified duration and based on the criteria in the policy (e.g., indication, weight-based dosing, and induction dosing history). Quantity-limit overrides are allowed only when criteria are met and are time-limited per the policy (examples below).

Prior authorization duration and basis: Approvals correspond to the medically necessary override period described in the criteria (for example, one-time overrides: 8 mL for 112 days for plaque psoriasis induction; 16 mL for 112 days for hidradenitis suppurativa induction). Ongoing approvals/dosing authorizations will be limited to the routine dispensing intervals (e.g., 2 mL per 28 days retail or 6 mL per 84 days home delivery when criteria are met).
Required documentation: Clinical documentation must verify the indication (plaque psoriasis or hidradenitis suppurativa), weight when relevant (e.g., ≥120 kg for weight-based dosing), and absence of prior Bimzelx claims in the past 130 days when requesting an induction override. Chart notes or prior pharmacy/medical claims supporting dosing history and necessity for induction or maintenance dosing should be submitted.
Quantity limits and overrides apply to retail or home delivery dispensing settings: Examples — retail/home delivery maximums, one-time induction overrides, and weight-based or indication-based alternative dispensing schedules are allowed only when the criteria in the policy are satisfied.

Coding & Claims Lookback

Coding guidance (no specific codes listed)mixed

No codes listed

Lookback for prior Bimzelx claims — absence of claims in the past 130 days

Lookback requirementAbsence of Bimzelx claims in the past 130 days to verify initiation for override eligibility

Used to confirmEligibility for one-time induction overrides for plaque psoriasis or hidradenitis suppurativa

Applies toRetail and home delivery dispensing settings

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorizations: 1-year approvals tied to quantity rules

Prior authorization approvals follow the Drug Quantity Limits and Override Criteria and, unless an exception is noted, are issued for a 1-year duration.

Note

Point-of-service application of Drug Quantity Management rule

At point of service, the Drug Quantity Management rule is applied to determine coverage; if the rule is not met, coverage will be determined by the listed Criteria.

Documentation Required

Submit appropriate codes and supporting documentation

When submitting claims, providers must bill using the most appropriate codes and include documentation sufficient to demonstrate that applicable quantity or override criteria are met (for example, absence of Bimzelx claims in the past 130 days or the clinical indication such as plaque psoriasis or hidradenitis suppurativa).

Key Definitions

Induction dosing — definition/values for induction dosing

DefinitionInduction dosing: initial higher-frequency or larger-volume dosing regimen used to achieve therapeutic effect during treatment initiation (examples below)

Plaque psoriasis induction example320 mg once every 4 weeks at Weeks 0, 4, 8, and 12 (supplied by an 8 mL one-time override)

Hidradenitis suppurativa induction example320 mg every 2 weeks at Weeks 0, 2, 4, 6, 8, 10, 12, and 14 (supplied by a 16 mL one-time override)

Background

Bimzelx (bimekizumab) is an interleukin‑17A and interleukin‑17F blocker with approved indications that include ankylosing spondylitis, non‑radiographic axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa. The policy implements a Drug Quantity Management program that sets a baseline dispensing maximum of 2 mL per 56 days for the available 160 mg/1 mL and 320 mg/2 mL presentations and defines specific, limited medical‑necessity exceptions for induction or weight‑based dosing per indication.

Step Therapy

Step	Requirement
1
No formal step therapy requirement is specified. Coverage is managed via Drug Quantity Limits and specific override criteria (e.g., induction and weight-based overrides); requests are evaluated against those criteria rather than a multi-step failure sequence.