CurrentCignaPolicy DQM018

Cimzia Drug Quantity Management Policy - Per Days

Defines quantity limits and exception criteria for Cimzia (certolizumab pegol) supplied as 200 mg vials or prefilled syringes for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCimzia Drug Quantity Management Policy - Per Days

Policy CodePolicy DQM018

Change TypeNew policy

Effective DateFeb 15, 2026

Next Review DateN/A

Key ActionRequest prior authorization for quantity exceptions; approvals are generally for 1 year with one-time overrides for 30 days.

SourceLink

POLICY UPDATE CHANGES

New policy created providing drug quantity limits and exception criteria for Cimzia.

1 yearstandard approval duration

30 daysone-time override duration

1 cartonretail vial max (28d)

3 cartonshome delivery vial max (84d)

2 syringesretail syringe max (28d)

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Coverage Criteria

Drug quantity limit criteria and exceptions

Quantity limits apply; exceptions are covered as medically necessary when ONE of the following criteria is met.

Default quantity limits: Apply standard quantity limits depending on strength/form and channel: 200 mg vials (two vials per carton) — retail maximum 1 carton (2 vials) per 28 days; home delivery maximum 3 cartons (6 vials) per 84 days. 200 mg prefilled syringes — retail maximum 2 syringes per 28 days; home delivery maximum 6 syringes per 84 days. Starter kit (6 syringes) — retail and home delivery maximum 6 syringes per 365 days.see Drug Quantity Limits

From Drug Quantity Limits section (see chunk 8)

Exception for plaque psoriasis dosing: If the patient is requesting Cimzia for the treatment of plaque psoriasis, approve 4 syringes or vials per 28 days at retail or 12 syringes or vials per 84 days at home delivery.indication = plaque psoriasis

Chunk 9

Induction or re-initiation override for non-starter products: If initiating treatment or requiring additional induction dosing, verified by absence of Cimzia claims in the past 130 days, approve a one-time override: non-starter products — 6 syringes or vials at retail or 10 syringes or vials at home delivery.no claims in past 130 days

Chunk 9

Induction or re-initiation override for starter kit: If the patient requires additional induction dosing, verified by absence of Cimzia claims in the past 130 days, approve a one-time override for 6 syringes (one starter pack) at retail or home delivery. The 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.no claims in past 130 days; consider past 365-day starter kit receipt

Chunk 10

Any request for a quantity that exceeds the Drug Quantity Limits listed for Cimzia must meet one of the enumerated exception criteria to be considered medically necessary. Any other exception to the listed quantity limits is considered not medically necessary.

Exceptions to the specified quantity limits are limited to the explicit criteria (for example, plaque psoriasis dosing or verified induction/re-initiation). Exceptions other than these specified criteria are considered not medically necessary.

Provider Actions and Administrative Notes

Prior Authorization

Quantity limit approvals and overrides

Approvals for quantity exceptions are provided per the Drug Quantity Management criteria. Standard approvals are issued for 1 year; 'one-time' overrides are issued for 30 days.

Standard approval duration: 1 year
One-time override duration: 30 days

Note

Additional authorization requirements

Meeting the Drug Quantity Management Program criteria does not satisfy other prior authorization or medical necessity requirements; additional prior authorization or medical necessity criteria may still be required separately.

Background

Cimzia (certolizumab pegol) is a tumor necrosis factor inhibitor 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 administered subcutaneously; when a 400 mg dose is required this is given as two separate 200 mg injections at different sites. Dosing regimens vary by indication and, for pediatric JIA, by patient weight. The product is supplied as 200 mg vials (two vials per carton) and as 200 mg prefilled syringes including a Starter Kit (6 syringes per kit).

Definitions

inv-09: Starter Kit — definition and related notes.

DefinitionStarter Kit = carton containing six 200 mg prefilled syringes (three sets of two syringes) provided to supply the three initial induction doses.

PurposeProvides sufficient drug supply for the three initial induction doses at the start of treatment.

Packaging noteStarter Kit contents should not be separated prior to use; counts toward annual starter-kit quantity limits.

Annual handlingApproval quantity for starter kit equals number of starter-kit syringes received in past 365 days plus 6 syringes when approving an additional starter pack.

Initial Therapy Criteria

Induction and starter kit

Induction dosing and starter kit handling

Induction dosing per product labeling: Induction regimens vary by indication (commonly 400 mg at Weeks 0, 2, and 4 for many adult indications; JIA induction is weight-based per labeling). When induction dosing or re-initiation is needed and there are no Cimzia claims in the past 130 days, a one-time override is allowed as specified in quantity limits.

Starter kit handling: Starter Kit contains six 200 mg prefilled syringes to provide the three initial induction doses. Initial quantity limits provide sufficient drug for a 28-day supply and one induction regimen per 365 days. If additional induction dosing is required (no claims in past 130 days), approve one starter pack (6 syringes) retail or home delivery; approval quantity should equal the number of starter kit syringes received in the past 365 days plus 6 syringes.

Quantity Limits

inv-11: Cimzia 200 mg vial (2 vials per carton) — retail limit representation (1 carton per 28 days).

ProductCimzia (certolizumab pegol) 200 mg vial — 2 vials per carton

Retail limit1 carton (2 vials) per 28 days

Unitcarton

Policy referenceDrug Quantity Limits — retail maximum quantity

inv-12: Cimzia 200 mg vial — home delivery limit representation (3 cartons per 84 days).

ProductCimzia (certolizumab pegol) 200 mg vial

Home delivery limit