CurrentCignaPolicy DQM012

Tremfya Subcutaneous Drug Quantity Management Policy - Per Days

Defines per-day/per-interval drug quantity limits and one-time override criteria for Tremfya (guselkumab) subcutaneous formulations for Cigna-administered health benefit plans. Applies to retail and home delivery supply limits and specifies medically necessary exceptions for induction or re-initiation dosing.

Policy Summary

PayerCigna

PolicyTremfya Subcutaneous Drug Quantity Management Policy - Per Days

Policy CodePolicy DQM012

Change TypeNew policy (quantity management with one-time overrides)

Effective DateDec 1, 2025

Next Review Date

Key ActionWhen absence of Tremfya claims for 130 days is verified, providers may request a one-time override for induction/re-initiation dosing per the product/formulation-specific quantities; meeting the Drug Quantity Management criteria does not satisfy other prior authorization or medical necessity requirements.

SourceLink

POLICY UPDATE CHANGES

New Drug Quantity Management policy for Tremfya effective 12/01/2025.

7Distinct formulation/channel quantity rules

130 daysRe-initiation lookback period

1,200 mgOne-time additional induction allowance

Coverage Summary

Scope: Defines per-interval quantity limits and one-time override criteria for Tremfya (guselkumab) subcutaneous formulations for Cigna-administered health benefit plans. Retail and home delivery maximum quantities vary by formulation: 100 mg (1 injector/syringe/pen) per 56 days for 100 mg/mL forms; 200 mg (1 pen/syringe) per 28 days retail and 600 mg (3 pens/syringes) per 84 days home delivery for 200 mg/2 mL forms; and 1,200 mg (6 pens/3 Induction Packs) per 365 days for the Induction Pack. The policy provides limited one-time overrides to accommodate induction dosing or re-initiation when criteria are met (see criteria for specific quantities and lookback requirements).

One-time Override — Exception Criteria

General Exception Rule

Exceptions to the quantity limits listed above are covered as medically necessary when ONE of the following criteria is met. Any other exception is considered not medically necessary.

For 100 mg/mL prefilled syringes, patient-controlled injectors, and pens: patient is initiating treatment for plaque psoriasis or psoriatic arthritis or requires additional induction dosing for plaque psoriasis or psoriatic arthritis, as verified by the absence of claims for Tremfya in the past 130 days.

Approve a one-time override for 200 mg (2 syringes, injectors, or pens) at retail or home delivery.

For 200 mg/2 mL prefilled pens and syringes: patient is initiating treatment for Crohn's disease or ulcerative colitis or requires additional induction dosing for Crohn's disease or ulcerative colitis, as verified by the absence of claims for Tremfya in the past 130 days.

Approve a one-time override for 84 days for an additional 1,200 mg (6 pens).

For Tremfya Induction Pack for Ulcerative Colitis or Crohn's Disease (2 x 200 mg/2 mL prefilled pens): patient requires additional induction dosing for Crohn's disease or ulcerative colitis, as verified by the absence of claims for Tremfya in the past 130 days.

Approve a one-time override for 84 days for an additional 1,200 mg (6 pens/3 Induction Packs). Approval quantity should be the number of mg the patient has received in the past 365 days plus 1,200 mg.

Provider Actions & Billing Rules

Prior Authorization

Drug Quantity Management override when initiating or re-initiating therapy

When absence of Tremfya claims for 130 days is verified, providers may request a one-time override for induction or re-initiation dosing according to the product/formulation-specific quantities. Meeting the Drug Quantity Management criteria does not satisfy other prior authorization or medical necessity requirements.

Verify no Tremfya claims in the prior 130 days before requesting the override.
Meeting DQM criteria does not satisfy other prior authorization or medical necessity requirements.

Billing Rule

Supply limits by formulation and channel

Adhere to the specified retail and home delivery maximum quantities per interval for each Tremfya formulation. Claims that exceed these limits require an approved exception or will be denied as not covered.

retail
home delivery
Claims exceeding the quantity limits require an approved exception or will be denied as not covered.

Documentation Required

Verification of prior claims and dosing history

Provide documentation to support the one-time override request: evidence of absence of Tremfya claims in the prior 130 days is required. For requests involving the Induction Pack override, document the number of mg of Tremfya the patient has received in the past 365 days so the approval quantity can be calculated as that amount plus 1,200 mg.

Evidence of no Tremfya claims in the prior 130 days.
For Induction Pack override, document mg received in past 365 days; approval quantity = prior 365-day mg + 1,200 mg.

Background

Background: Tremfya (guselkumab) is an interleukin-23 (IL-23) blocker indicated for Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The policy sets retail and home delivery maximum quantities per interval for the various subcutaneous formulations and provides limited one-time overrides to accommodate induction dosing or re-initiation when the specified criteria are met.

Policy numberDQM012

SubjectTremfya (guselkumab) drug quantity management

PayerCigna

Effective date2025-12-01

StatusCURRENT

Revision History

2025-12-01addedLatest

New Drug Quantity Management policy for Tremfya effective 12/01/2025.

2025-12-01policy_effectiveLatest

Policy DQM012 effective 12/01/2025 establishes per-channel/formulation quantity limits and one-time override criteria for Tremfya (guselkumab) subcutaneous formulations.

2025-12-01quantity_limits_documented

Retail and home delivery maximum quantities defined by formulation (e.g., 100 mg per 56 days for 100 mg forms; 200 mg per 28 days retail and 600 mg per 84 days home delivery for 200 mg/2 mL pens/syringes; Induction Pack max 1,200 mg per 365 days).

2025-12-01override_criteria_documented

One-time overrides specified for induction or re-initiation when no Tremfya claims in prior 130 days (e.g., 200 mg one-time override for 100 mg forms; additional 1,200 mg for 200 mg forms or induction packs with 84-day approvals and induction-pack calculation using prior 365-day mg + 1,200 mg).

Policy Summary

PayerCigna

PolicyTremfya Subcutaneous Drug Quantity Management Policy - Per Days

Policy CodePolicy DQM012

Change TypeNew policy (quantity management with one-time overrides)

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Tremfya Subcutaneous Drug Quantity Management Policy - Per Days

Coverage Summary

One-time Override — Exception Criteria

Applicable Codes

Provider Actions & Billing Rules

Clinical Evidence & References

Background

Definitions

Revision History