CurrentCignaPolicy N/A

Inflammatory Conditions - Tremfya Subcutaneous Drug Quantity Management Policy - Per Days

Defines drug quantity limits and exception (one-time override) criteria for Tremfya (guselkumab) formulations for Cigna-administered health benefit plans; applies to coverage/authorization decisions at point of service for pharmacy and specialty drug dispensing.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Tremfya Subcutaneous Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeClarification

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a one-time override request (generally 30 days) with documentation showing no Tremfya claims in the prior 130 days and the indication to justify initiation or additional induction dosing; when approving induction packs, document the total mg received in the past 365 days and add 1,200 mg.

SourceLink

POLICY UPDATE CHANGES

Override criteria for Tremfya 100 mg/mL injectors and prefilled syringes were clarified to be indication-specific (plaque psoriasis or psoriatic arthritis).

100Retail/home maximum quantity for 100 mg formulations

200Retail maximum quantity for 200 mg pen/syringe

600Home delivery max for 200 mg pen/syringe

1,200Induction pack annual max (6 pens / 3 induction packs)

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Quantity Limit Exceptions & One-time Overrides

General Policy Statement

Exceptions to the listed quantity limits are covered as medically necessary when the criteria below are met. Any other exception is not medically necessary.

ALL of the following

One-time approvals are provided for 30 days unless otherwise noted.

Tremfya 100 mg/mL prefilled syringes, patient-controlled injectors, and pens - One-time override

Approve a one-time override for 200 mg (2 devices) at retail or home delivery when ALL of the following are met:

ALL of the following

Patient is initiating treatment for plaque psoriasis OR initiating treatment for psoriatic arthritis OR requires additional induction dosing for plaque psoriasis OR requires additional induction dosing for psoriatic arthritis
Indication/requirement must be verified by absence of claims for Tremfya in the past 130 days.
Verification is via absence of claims for Tremfya in the past 130 days

Tremfya 200 mg/2 mL prefilled pens and syringes - One-time override

Approve a one-time override for an additional 1,200 mg (6 pens) for 84 days when ALL of the following are met:

ALL of the following

Patient is initiating treatment for Crohn's disease OR initiating treatment for ulcerative colitis OR requires additional induction dosing for Crohn's disease OR requires additional induction dosing for ulcerative colitis
Indication/requirement must be verified by absence of claims for Tremfya in the past 130 days.
Verification is via absence of claims for Tremfya in the past 130 days

Tremfya Induction Pack for Ulcerative Colitis or Crohn's Disease - One-time override

Approve a one-time override for an additional 1,200 mg (6 pens / 3 Induction Packs) for 84 days when ALL of the following are met:

ALL of the following

Patient requires additional induction dosing for Crohn's disease OR requires additional induction dosing for ulcerative colitis
Indication/requirement must be verified by absence of claims for Tremfya in the past 130 days.
Approval quantity should equal the number of mg the patient has received in the past 365 days plus 1,200 mg
Document the total mg received in the past 365 days and include this calculation in the request.

Product Descriptions / NDCs

NDC / product descriptions referencedNDC|mixed

100 mg/mL	single-dose patient-controlled injector / prefilled syringe / prefilled pen (strength/form)
200 mg/2 mL	single-dose prefilled pen / prefilled syringe (strength/form)
200 mg/20 mL	single-dose vial for IV (not addressed in this policy)
Induction Pack	Ulcerative Colitis or Crohn's Disease Induction Pack: 2 x 200 mg/2 mL prefilled pens

Authorization, Documentation & Denial Rules

Prior Authorization

Request one-time override when induction/initiation criteria met

Submit a request for a one-time override (generally 30 days unless otherwise noted) and include documentation that there have been no Tremfya claims in the prior 130 days and the clinical indication (plaque psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis) supporting initiation or additional induction dosing.

Documentation Required

Approval quantity calculation for induction packs

When approving additional induction pack dosing, document the total milligrams of Tremfya the patient has received in the past 365 days and add 1,200 mg; include this calculation and the resulting approval quantity in the request.

Dispensing Limits and Verification Thresholds

Quantity and verification thresholds

Claim lookback for initiation/induction verificationNo Tremfya claims in the past 130 days

100 mg formulation retail/home dispensing limit100 mg (1 injector/syringe/pen) per 56 days

200 mg formulation retail dispensing limit200 mg (1 pen/syringe) per 28 days

200 mg formulation home delivery limit600 mg (3 pens/syringes) per 84 days

Induction pack annual limit1,200 mg (6 pens/3 Induction Packs) per 365 days

100 mgRetail/home max for 100 mg (per 56 days)

Clinical & Policy Context

Tremfya (guselkumab) is an IL-23 blocker indicated for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. (See approved indications and availability.) [[3]][[6]]

Dosing and induction regimens differ by indication: for Crohn's disease and ulcerative colitis induction options include an IV 200 mg infusion at Weeks 0, 4, and 8 or a 400 mg SC induction (given as two consecutive 200 mg injections) at Weeks 0, 4, and 8, with maintenance dosing options thereafter (either 100 mg SC Q8W starting at Week 16 or 200 mg SC Q4W starting at Week 12). For plaque psoriasis and psoriatic arthritis, the usual regimen is 100 mg SC at Week 0 and Week 4, then 100 mg SC every 8 weeks. [[4]][[5]]

Tremfya is supplied in multiple formulations that the policy manages separately, including 100 mg/mL single‑dose injectors, prefilled syringes, and pens, and 200 mg/2 mL prefilled pens and syringes; an IV 200 mg/20 mL vial exists but is not addressed in this policy. An Ulcerative Colitis or Crohn's Disease Induction Pack consists of 2 × 200 mg/2 mL prefilled pens. [[6]]

This Drug Quantity Management policy is intended to limit premature dose escalation by setting standard quantity limits and defining exception (one‑time override) criteria tied to initiation or induction needs. One‑time overrides are generally provided for 30 days unless otherwise noted in the specific override criteria. [[7]]

To support initiation or additional induction dosing, the policy requires verification of no Tremfya claims in the prior 130 days. For 100 mg formulations, a one‑time override can allow 200 mg (2 devices) at retail or home delivery when the patient is initiating therapy for plaque psoriasis or psoriatic arthritis or requires additional induction dosing for those indications. For 200 mg SC formulations, a one‑time override can allow an additional 1,200 mg (6 pens) for 84 days when initiating therapy for Crohn's disease or ulcerative colitis or when additional induction dosing is required. For Induction Packs, a one‑time override can allow an additional 1,200 mg (6 pens / 3 Induction Packs) for 84 days, and the approval quantity should equal the mg the patient has received in the past 365 days plus 1,200 mg. [[10]][[11]][[12]][[8]][[9]]

Defined Terms

Definitions

One-time overrideA single approval for additional quantity beyond the standard quantity limit; generally provided for 30 days unless otherwise specified.

Induction PackA packaged supply intended for induction dosing in ulcerative colitis or Crohn's disease consisting of 2 x 200 mg/2 mL prefilled pens.

Policy Updates

2024-01-03annual_review

Annual revision; no criteria changes noted in the summary of changes.

2024-10-09early_annual_revision

Policy name changed to 'Inflammatory Conditions - Tremfya Subcutaneous Drug Quantity Management Policy - Per Days' and override criteria for 100 mg patient-controlled injectors and prefilled syringes were clarified to be indication-specific for plaque psoriasis or psoriatic arthritis.

2025-04-09early_annual_revision

New quantity limits and override criteria added for 200 mg/2 mL prefilled pens and syringes and induction pack; override criteria expanded to include ulcerative colitis in initiation/additional induction dosing for 200 mg formulations.