CurrentCignaPolicy IP0704

Tremfya Intravenous

Prior authorization policy for Tremfya intravenous infusion (guselkumab IV) for induction treatment of moderate to severe Crohn's disease and ulcerative colitis in adults, including clinical criteria, dosing for induction, exclusions (concurrent biologic/targeted therapy), coding, and prescriber specialty requirements.

Policy Summary

PayerCigna

PolicyTremfya Intravenous

Policy CodePolicy IP0704

Change TypeNew policy; revisions adding CD and modifying UC criteria

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization for Tremfya IV; initial approval requires prescription by or consultation with a gastroenterologist and approvals are provided for three months sufficient for induction dosing.

POLICY UPDATE CHANGES

New policy created (summary of changes = New policy).

Crohn's Disease indication added as a condition of approval.

For Ulcerative Colitis, removed options of approval that required the patient to have tried one systemic therapy and removed allowance for pouchitis with prior antibiotic/probiotic/corticosteroid enema or mesalamine enema.

2Covered Indications (induction)

3Induction Doses Approved

J1628Covered HCPCS Code

3Policy Duration per Approval (months)

Coverage Summary

Coverage summary: This prior authorization policy (Policy Number IP0704, effective 09/01/2025, last reviewed 05/15/2025) provides coverage with criteria (covered_with_criteria) for Tremfya intravenous infusion (guselkumab IV) as induction therapy in adults (≥18 years) with moderate to severe Crohn's disease or ulcerative colitis. When criteria are met, IV induction is approved as three 200 mg infusions at Weeks 0, 4, and 8 (approval provided for a three-month period to allow completion of induction), with continued maintenance care transitioned to subcutaneous formulation per policy guidance.

Key Policy Facts

Covered Indications (induction)2

Induction Doses Approved3

Covered HCPCS Code1

Policy Duration per Approval (months)1

Policy statusCURRENT

Initial Therapy Criteria — Induction

Dosing — Induction and Post-Induction Maintenance

Conditions Not Covered / Not Medically Necessary

Applicable Codes

Covered HCPCS (when criteria met)HCPCSCovered

J1628

Injection, guselkumab, 1 mg

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Tremfya IV. All approvals are provided for three months, which is sufficient for the three-dose IV induction regimen (200 mg at Weeks 0, 4, and 8). Affected/covered HCPCS code: J1628.

Approval duration: 3 months (adequate for three induction doses).
Covered HCPCS: J1628 (Injection, guselkumab, 1 mg).

Documentation Required

Specialist prescriber/consult requirement

Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated — i.e., a gastroenterologist.

Clinical Evidence & Definitions

Background: Tremfya IV (guselkumab) is a monoclonal antibody that inhibits the p19 subunit of interleukin-23 (IL-23) and is indicated for induction treatment of moderate to severe Crohn's disease and ulcerative colitis in adults. The approved IV induction regimen is 200 mg administered as an IV infusion at Weeks 0, 4, and 8 (three doses); maintenance therapy is provided with the subcutaneous Tremfya formulation per labeling (examples include 100 mg SC at Week 16 then every 8 weeks, or 200 mg SC at Week 12 then every 4 weeks).

Revision History

11/01/2024New policy created

New policy created (summary of changes = New policy).

05/15/2025Crohn's Disease indication added

Crohn's Disease indication added as a condition of approval.

09/01/2025For Ulcerative Colitis, removed prior systemic therapy option and pouchitis allowanceLatest

Policy Summary

PayerCigna

PolicyTremfya Intravenous

Policy CodePolicy IP0704

Change TypeNew policy; revisions adding CD and modifying UC criteria

Effective DateSep 1, 2025

Next Review Date

On This Page

Denial Risk

Coverage limited to listed indications and dosing

Claims submitted for services that are not accompanied by covered diagnosis/procedure codes under this policy will be denied as not covered. Services provided outside the dosing documented in the policy (approved 200 mg IV at Weeks 0, 4, and 8 for induction) will be denied; requests for doses outside the established dosing will be considered on a case‑by‑case basis by a clinician. Reference covered HCPCS code: J1628.

Claims without covered diagnosis/procedure codes will be denied as not covered.
Approved IV induction dosing: 200 mg IV at Weeks 0, 4, and 8 (three doses).
Requests for non‑standard doses considered case‑by‑case.