CurrentCignaPolicy IP0704

Tremfya Intravenous Prior Authorization Policy

Defines Cigna prior authorization, coverage criteria, dosing, excluded uses, and coding for Tremfya intravenous infusion (guselkumab IV) for induction treatment of Crohn's disease and ulcerative colitis in adults.

Policy Summary

PayerCigna

PolicyTremfya Intravenous Prior Authorization Policy

Policy CodePolicy IP0704

Change TypeAdded/Revised criteria

Effective DateMar 15, 2026

Next Review Date

Key ActionPrior Authorization is required for Tremfya IV; initial approvals require prescription by or consultation with a gastroenterologist and are provided for three months.

SourceLink

POLICY UPDATE CHANGES

Policy created for Tremfya IV with coverage criteria for Crohn's disease and ulcerative colitis.

Crohn's Disease: new condition of approval added (05/15/2025) and later some initial-therapy options were removed (11/01/2025 and 03/15/2026 revisions).

Ulcerative Colitis: removal of prior options of approval such as trial of systemic therapy or pouchitis-specific criteria (09/01/2025).

2Covered Indications (adult)

3 dosesInduction dosing regimen

200 mgIV dose per administration

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Coverage Summary

Scope: This policy defines prior authorization and coverage criteria for Tremfya (guselkumab) intravenous (IV) infusion as an induction treatment for adults with moderate to severe Crohn's disease and ulcerative colitis. Coverage stance: Covered with criteria when used for FDA‑approved induction in adults (≥ 18 years) and prescribed by or in consultation with a gastroenterologist.

Induction regimen: Approvals are provided for three months to allow completion of the IV induction course; the approved IV induction dosing is 200 mg administered by IV infusion at Weeks 0, 4, and 8 (three doses) for both Crohn's disease and ulcerative colitis.

Maintenance: Following IV induction, maintenance therapy is with Tremfya subcutaneous (SC) per the prescribing information (options include 100 mg SC at Week 16 then every 8 weeks or 200 mg SC at Week 12 then every 4 weeks), and the lowest effective maintenance dose is recommended.

Guideline alignment: Clinical practice guidelines from the AGA and ACG support use of advanced therapies, including IL‑23 inhibitors, for induction and continuation into maintenance in moderate to severe disease.

Policy Metadata

Effective date03/15/2026

Last review03/15/2026

Policy statusCURRENT

Primary billing HCPCSJ1628

Covered indications (adult)2

Initial Therapy Criteria (Induction)

Not Medically Necessary / Exclusions

Not Medically Necessary (Conditions Not Covered)

Tremfya intravenous for any other use is considered not medically necessary, including but not limited to:

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition

Combination therapy generally not recommended due to a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy; does not exclude use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

Applicable Codes

HCPCS - Covered when criteria metHCPCSCovered

J1628

Injection, guselkumab, 1 mg

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Prior authorization (PA) is required for benefit coverage of Tremfya IV. Approvals are provided for three months to allow the patient to receive three induction doses; extended approvals are allowed if the patient continues to meet the policy Criteria and Dosing. Requests for doses outside the established dosing documented in the policy will be considered on a case-by-case basis by a clinician.

J1628

Documentation Required

Specialist prescribing or consultation requirement

Initial approval requires Tremfya IV to be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist).

Clinical Evidence & References

Evidence sources supporting the induction regimen and guideline alignment include the Tremfya IV/SC prescribing information (Janssen Biotech; March 2025) and clinical practice guidelines from the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) for Crohn's disease and ulcerative colitis (2024–2025).

These references provide the basis for the three‑dose IV induction schedule and the recommendation to transition to Tremfya SC for maintenance, and reflect guideline recommendations endorsing advanced therapies for moderate to severe disease.

Background

Background: Tremfya (guselkumab) IV is indicated for induction treatment of adults with moderate to severe active Crohn's disease and ulcerative colitis. The IV induction course is a three‑dose regimen of 200 mg IV at Weeks 0, 4, and 8.

After completion of IV induction, the prescribing information recommends maintenance with Tremfya SC formulations (for example, 100 mg SC at Week 16 then every 8 weeks or 200 mg SC at Week 12 then every 4 weeks), with the lowest effective maintenance dose advised.

Policy context: Prior authorization is required, initial approvals are granted for three months to allow receipt of the three induction doses, and the medication must be prescribed by or in consultation with a gastroenterologist. Clinical guidelines (AGA and ACG) support the use of advanced therapies, including IL‑23 inhibitors, in moderate to severe disease and endorse continuing effective induction therapies for maintenance.

Induction therapy (definition)Initial multi-dose treatment intended to induce remission (for Tremfya IV: 200 mg IV at Weeks 0, 4, and 8).

Revision History

11/01/2024added

Policy created for Tremfya IV with coverage criteria for Crohn's disease and ulcerative colitis.

05/15/2025revised

Crohn's Disease: new condition of approval added (selected revision).

09/01/2025revised

Ulcerative Colitis: removed prior options of approval such as trial of one systemic therapy and pouchitis-specific criteria.