CurrentUnitedHealthcarePolicy CS2026D00134D

Tremfya (guselkumab) — Intravenous Induction for Inflammatory Bowel Disease

Defines medical benefit coverage criteria for intravenous Tremfya (guselkumab) induction therapy for moderately to severely active ulcerative colitis and Crohn's disease for UnitedHealthcare Community Plan members; subcutaneous Tremfya is handled under the pharmacy benefit.

Policy Summary

PayerUnitedHealthcare

PolicyTremfya (guselkumab) — Intravenous Induction for Inflammatory Bowel Disease

Policy CodePolicy CS2026D00134D

Change TypeTemplate updatesupporting information added

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization documenting three intravenous induction doses and prior targeted therapy history including failures, contraindications, or intolerance to two targeted immunomodulators.

SourceLink

POLICY UPDATE CHANGES

Removed content/language pertaining to the state of Louisiana.

Template Update and Supporting Information added.

3induction IV doses authorized

J1628HCPCS listed

200 mgIV induction dose

45%Week 44 remission (100 mg)

50%

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Coverage Criteria for Intravenous Tremfya (guselkumab)

Ulcerative Colitis (UC) - Induction

Covered when ALL of the following are met

UC diagnosis: Diagnosis of moderately to severely active ulcerative colitis

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Prior therapy requirement: Either prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine) OR prior treatment with a targeted immunomodulator FDA-approved for ulcerative colitis (examples include adalimumab, vedolizumab, mirikizumab, upadacitinib, golimumab, risankizumab, ustekinumab, tofacitinib)

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Targeted agent history: History of failure, contraindication, or intolerance to two targeted immunomodulators FDA-approved for ulcerative colitis (document drug name, dates, and duration of each trial)

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Dosing and administration: Tremfya is to be administered as three intravenous induction doses in accordance with U.S. FDA‑labeled dosing for ulcerative colitis3 IV induction doses

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Concomitant therapy and prescriber: Patient is not receiving Tremfya in combination with another targeted immunomodulator; therapy is prescribed by or in consultation with a gastroenterologist

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Crohn's Disease (CD) - Induction

Covered when ALL of the following are met

CD diagnosis: Diagnosis of moderately to severely active Crohn's disease

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Prior conventional or targeted therapy: Either failure to one conventional therapy at maximally indicated doses (corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) OR prior treatment with a targeted immunomodulator FDA‑approved for Crohn's disease

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Targeted agent history: History of failure, contraindication, or intolerance to two targeted immunomodulators FDA‑approved for Crohn's disease (document drug name, dates, and duration of each trial)

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Dosing and administration: Tremfya is to be administered as three intravenous induction doses in accordance with U.S. FDA‑labeled dosing for Crohn's disease

Evidence-based considerations

Evidence and indications referenced for coverage decisions

Induction efficacy (UC1): Clinical remission at Week 12 was achieved in 23% of Tremfya-treated patients vs. 8% with placebo (treatment difference 15%, p < 0.001).Week 12 remission

UC1 trial data supports induction efficacy

Maintenance efficacy (UC2): Clinical remission at Week 44 was achieved in 45% with Tremfya 100 mg and 50% with Tremfya 200 mg vs. 19% with placebo (treatment differences 25% and 30%, p < 0.001).Week 44 remission

UC2 maintenance trial with subjects who responded to induction

FDA indication: Tremfya is FDA-indicated for moderately to severely active ulcerative colitis in adults (informational).regulatory

Use of Tremfya (guselkumab) in combination with another targeted immunomodulator is excluded. The policy specifically states the patient must not be receiving Tremfya concurrently with other targeted immunomodulators (examples include adalimumab, certolizumab, etanercept, vedolizumab, baricitinib, mirikizumab, abatacept, upadacitinib, golimumab, risankizumab, ustekinumab, tofacitinib) as a condition of coverage for intravenous induction dosing.

Authorization for intravenous Tremfya is contingent on this exclusion and will be issued only when the patient is not receiving concomitant targeted immunomodulator therapy.

Clinical trials of intravenous Tremfya for ulcerative colitis did not permit concomitant biologic therapies or JAK inhibitors. Trial populations were allowed stable doses of aminosalicylates, immunomodulators (azathioprine, 6‑mercaptopurine, methotrexate), and oral corticosteroids (up to 20 mg/day prednisone equivalent), but the induction studies expressly prohibited use of other biologics or JAK inhibitors.

Because the induction trials excluded concomitant biologic or JAK inhibitor therapy, the policy does not support use of Tremfya in combination with those agents based on the available trial data.

Subcutaneous, self‑administered Tremfya (guselkumab) is managed under the pharmacy benefit and is not covered under this medical benefit drug policy for intravenous administration. Providers should obtain subcutaneous formulations through the member’s pharmacy benefit as appropriate.

The FDA information included in this policy is provided for informational purposes only. FDA approval alone is not a basis for coverage; coverage determinations must follow applicable plan-specific contractual, federal, or state requirements.

When applying this policy, verify the relevant federal, state, or contractual benefit terms, because those requirements govern in the event of a conflict with the policy guidance.

Coding and Clinical Metrics

HCPCS CodesHCPCS

J1628

Injection, guselkumab, 1 mg

NDCNDC

57894-0650-02

200 mg/20 mL vial

ICD-10 CodesICD-10

K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with intestinal obstruction

1–10 of 78

1/8

Informational - drugmixed

Tremfya (guselkumab) listed in FDA indications

modified Mayo score (mMS) — enrollment criteria

Enrollment mMS rangeModified Mayo score (mMS) between 5 and 9 required for trial enrollment

Endoscopic subscore requirementEndoscopic subscore (ES) of 2 or 3 required (ES=2: marked erythema/loss of vascular pattern/friability/erosions; ES=3: spontaneous bleeding and ulceration)

Disease classificationSubjects with mMS 5–9 and ES 2 or 3 classified as moderately to severely active ulcerative colitis

Induction duration

Induction treatment regimenIntravenous Tremfya induction administered at Week 0, Week 4, and Week 8 (three IV doses)

Provider Actions, Authorization, and Documentation

Prior Authorization

Authorization for 3 induction doses

Prior authorization is required for three intravenous induction doses of Tremfya when criteria are met. Authorization will be issued specifically for the three FDA‑labeled IV induction doses for Crohn's disease or ulcerative colitis.

Authorization covers 3 intravenous induction doses (FDA‑labeled regimen).
Prescribed by or in consultation with a gastroenterologist is required.

Prior Authorization

Prior authorization for Tremfya maintenance

Prior authorization is required for ongoing Tremfya maintenance following induction. Documentation should confirm the clinical response to induction and state the intended maintenance dosing regimen (e.g., 100 mg every 8 weeks or 200 mg every 4 weeks as studied).

Document induction response (clinical remission/response at ~12 weeks) and planned maintenance dose and frequency.
Maintenance dosing examples from trials: Tremfya 100 mg every 8 weeks or 200 mg every 4 weeks.

Background and Clinical Context

Guselkumab (Tremfya) is a human monoclonal IgG1λ antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting IL‑23 receptor interaction and downstream proinflammatory cytokine signaling. This mechanism of action underlies its therapeutic role in immune‑mediated conditions and supports the intravenous induction regimen covered by the policy for inflammatory bowel disease.

Tremfya is available in intravenous formulation for induction under the medical benefit and as a subcutaneous formulation for self‑administration under the pharmacy benefit; the policy addresses the medical‑benefit (intravenous) use and refers providers to pharmacy benefit processes for subcutaneous dosing.

Definitions

Tremfya (guselkumab) — definition and benefit distinction

Drug definitionTremfya (guselkumab) is a human monoclonal IgG1λ antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23)

Benefit distinctionIntravenous formulation for induction is managed under the medical benefit; subcutaneous self‑administered formulation is obtained under the pharmacy benefit

Mechanism summaryInhibits IL‑23 interaction with its receptor, reducing downstream proinflammatory cytokine release

modified Mayo score (mMS) — 3-component definition

ComponentsThree‑component disease activity score: stool frequency, rectal bleeding, and endoscopy (each scored 0–3)

Score rangeTotal mMS ranges from 0 to 9

Revision History

2026-04-01template_updateLatest

Template updated and supporting information added; removed content/language pertaining to the state of Louisiana; previous policy version CS2025D00134C archived.