CurrentCignaPolicy N/A

Inflammatory Conditions - Cimzia Drug Quantity Management Policy - Per Days

Defines Cigna's drug quantity limits, one-time override rules, and approval criteria for Cimzia (certolizumab pegol) 200 mg vials and prefilled syringes (including Starter Kit) for inflammatory indications; applies to retail and home delivery supply channels. Approvals are typically for 1 year unless noted; one-time overrides are 30 days.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Cimzia Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeClarified / Revised

Effective Date

Next Review Date

Key ActionAt point of service, if quantity limits are not met, request one-time overrides for induction dosing with documentation of absence of Cimzia claims in the past 130 days.

POLICY UPDATE CHANGES

Policy Statement was updated to clarify that one-time overrides are provided for 30 days in duration.

A note was added clarifying how Starter Kit approval quantity should be calculated (number previously received in past 365 days plus 6 syringes).

Policy updated to reflect existing quantity limits when product obtained via home delivery.

6Starter Kit syringes per kit

2Retail vial/carton per 28 days

3Home delivery cartons per 84 days

130Prior claim lookback (days)

Cimzia (certolizumab pegol) is a tumor necrosis factor inhibitor (TNFi) indicated for multiple inflammatory conditions including ankylosing spondylitis, Crohn's disease, juvenile idiopathic arthritis, non-radiographic axial spondyloarthritis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. It is supplied as 200 mg vials (lyophilized powder for reconstitution; cartons contain two single‑dose vials) and 200 mg prefilled syringes (cartons contain two syringes). A Starter Kit contains six 200 mg prefilled syringes to cover induction dosing. The policy distinguishes supply channels: retail and home delivery, each with specific quantity limits. Approvals under this Drug Quantity Management program are typically for 1 year, and one-time overrides are provided for 30 days. Scope: defines Cigna's drug quantity limits, one-time override rules, and approval criteria for Cimzia 200 mg vials and prefilled syringes (including Starter Kit) across retail and home delivery channels.

General Coverage Statement

Cimzia 200 mg syringes or vials are covered as medically necessary when the following criteria are met. Any other exception is considered not medically necessary.

ALL of the following

Requested product is Cimzia (certolizumab pegol) 200 mg vials or 200 mg prefilled syringes (including Starter Kit).
Supply and quantity requests conform to specified retail or home delivery maximum quantities or meet one of the specified approval exceptions (plaque psoriasis, initiation/induction dosing, or starter kit induction override).

Standard Drug Quantity Limits

Standard Drug Quantity Limits (per product and channel)

Drug quantity limits applied unless an approved exception/override criteria is met:

ANY of the following

Vials (carton=2 vials): Cimzia 200 mg vials (two vials per carton): Retail maximum quantity = 1 carton (2 vials) per 28 days; Home Delivery maximum quantity = 3 cartons (6 vials) per 84 days.
Prefilled syringes: Cimzia 200 mg prefilled syringes (two syringes per carton): Retail maximum quantity = 2 syringes per 28 days; Home Delivery maximum quantity = 6 syringes per 84 days.
Starter Kit: Cimzia 200 mg prefilled syringes Starter Kit (6 syringes per kit): Retail maximum quantity = 6 syringes per 365 days; Home Delivery maximum quantity = 6 syringes per 365 days.

Cimzia quantity thresholds / key values

Claim lookback for prior Cimzia useAbsence of claims in the past 130 days

Retail maximum quantity (vials)1 carton (2 vials) per 28 days

Home delivery maximum quantity (vials)3 cartons (6 vials) per 84 days

Retail maximum quantity (prefilled syringes)2 syringes per 28 days

Home delivery maximum quantity (prefilled syringes)6 syringes per 84 days

Starter Kit annual maximum6 syringes per 365 days (retail or home delivery)

Initial / Induction Dosing Exceptions

Initiation / Additional Induction Dosing Exception (one-time override)

Approve a one-time override when ANY of the following initiation conditions are met:

ANY of the following

Initiation condition: Patient is initiating treatment with Cimzia or requires additional induction dosing, as verified by the absence of claims for Cimzia in the past 130 days.absence of claims in the past 130 days
If condition met: Approve one-time override quantities: 6 syringes or vials at retail OR 10 syringes or vials at home delivery.6 retail; 10 home delivery
One-time overrides are provided for 30 days in duration.

Starter Kit Exception (one-time override)

Approve when ALL of the following are met:

ALL of the following

Verification: Patient requires additional induction dosing, as verified by the absence of claims for Cimzia in the past 130 days.absence of claims in the past 130 days
Override quantity: Approve a one-time override for 6 syringes (one starter pack) at retail or home delivery.6 syringes
One-time overrides are provided for 30 days in duration.
Calculation note: Note: Approval quantity should equal the number of Cimzia 200 mg Starter Kit syringes the patient has received in the past 365 days plus 6 syringes (applies to both retail and home delivery).previous 365 days + 6 syringes

Plaque Psoriasis Exception

If the patient is requesting Cimzia for plaque psoriasis, approve the following quantities:

ALL of the following

Indication is plaque psoriasis.
Retail vs Home Delivery: Approve quantity: 4 syringes or vials per 28 days at retail OR 12 syringes or vials per 84 days at home delivery.4 per 28 days retail; 12 per 84 days home delivery

Provider Actions & Billing Rules

Prior Authorization

Quantity limit adherence and override requests

If the Drug Quantity Management rule is not met at point of service, providers must request a one-time override to cover induction or other quantity exceptions. One-time overrides require supporting documentation (see related documentation requirements) and are temporary: one-time overrides are provided for 30 days. All other approvals are provided for 1 year unless otherwise noted.

Request a one-time override at point of service when quantity limits are not met
Provide supporting documentation with the override request
One-time overrides = 30 days; standard approvals = 1 year

Documentation Required

Verify prior claims

To qualify for initiation or additional induction one-time overrides, providers must verify and document the absence of any Cimzia claims in the past 130 days. Include this documentation with the override request to demonstrate the patient is initiating therapy or requires induction dosing.

Document no Cimzia claims in past 130 days
Attach verification when requesting initiation/additional induction one-time overrides

Billing Rule

Adhere to channel-specific maximum quantities

When submitting claims, bill quantities that do not exceed the channel-specific maximums (retail or home delivery). Do not bill quantities above the retail or home delivery maximum quantity limits unless an approved override is on file.

Retail maximums: 1 carton (2 vials) per 28 days; or 2 prefilled syringes per 28 days
Home delivery maximums: 3 cartons (6 vials) per 84 days; or 6 prefilled syringes per 84 days
Starter Kit maximum: 6 syringes per 365 days (retail or home delivery)
If an override is approved (e.g., initiation/induction), bill only the approved quantity

Definitions & Clinical Evidence

One-time override: A temporary approval provided for 30 days to allow additional induction dosing or Starter Kit dispensing when initiation/induction criteria are met (for example, verified absence of Cimzia claims in the past 130 days). One-time overrides may authorize specified additional quantities (e.g., 6 syringes or vials at retail or 10 syringes or vials at home delivery for initiation/additional induction dosing; or one Starter Kit = 6 syringes when Starter Kit criteria are met).

Prescribing information: Cimzia prescribing information, UCB; September 2024.

Revision History

02/10/2025clarifiedLatest

Policy Statement was updated to clarify that one-time overrides are provided for 30 days in duration.

02/10/2025clarified

A note was added clarifying how Starter Kit approval quantity should be calculated (number previously received in past 365 days plus 6 syringes).

02/10/2025revised

Policy updated to reflect existing quantity limits when product obtained via home delivery.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Cimzia Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeClarified / Revised

Effective Date

Next Review Date

Key ActionAt point of service, if quantity limits are not met, request one-time overrides for induction dosing with documentation of absence of Cimzia claims in the past 130 days.

On This Page

OpenPayer

Inflammatory Conditions - Cimzia Drug Quantity Management Policy - Per Days

Coverage Summary & General Policy

Standard Drug Quantity Limits

Initial / Induction Dosing Exceptions

Plaque Psoriasis Exception

Provider Actions & Billing Rules

Applicable Codes

Definitions & Clinical Evidence

Revision History