ModifiedUnitedHealthcarePolicy 2026D0134D

Tremfya (guselkumab) — Intravenous for Ulcerative Colitis and Crohn's Disease (Medical Benefit)

Medical benefit policy for provider-administered (intravenous) Tremfya (guselkumab) for treatment of moderately to severely active ulcerative colitis and Crohn's disease under UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerUnitedHealthcare

PolicyTremfya (guselkumab) — Intravenous for Ulcerative Colitis and Crohn's Disease

Policy CodePolicy 2026D0134D

Change TypeCriteria revised — combination restriction and prior systemic targeted immunomodulator requirement

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization for intravenous Tremfya; authorization will be issued for three induction IV doses when policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

Replaced criterion limiting combination use with 'another systemic targeted immunomodulator for treatment of the same indication'.

Specified prior treatment requirement to 'systemic targeted immunomodulator FDA-approved for the treatment of ulcerative colitis/Crohn's disease'.

Application section added to indicate policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

Updated References section to reflect most current information.

3induction IV doses authorized

701UC1 subjects

23% vs 8%Week 12 remission (Tremfya vs PBO)

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Week 44 remission (100/200 mg vs PBO)

Coverage Criteria for Tremfya (guselkumab) IV

Ulcerative Colitis - Induction

Covered when ALL of the following are met

UC Induction Coverage: Diagnosis of moderately to severely active ulcerative colitis

IV induction dosing: Tremfya is to be administered as three intravenous induction doses in accordance with the U.S. FDA labeled dosing for UC3 IV doses

Authorization will be issued for 3 induction doses

No concurrent systemic targeted immunomodulator: Patient is not receiving Tremfya in combination with another systemic targeted immunomodulator for treatment of the same indication

Examples of systemic targeted immunomodulators are listed in policy (e.g., adalimumab, vedolizumab, risankizumab, ustekinumab, upadacitinib, tofacitinib)

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 systemic targeted immunomodulator FDA-approved for the treatment of ulcerative colitis

See policy for examples of systemic targeted immunomodulators

Crohn's Disease - Induction

Covered when ALL of the following are met

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

IV induction dosing: Tremfya is to be administered as three intravenous induction doses in accordance with the U.S. FDA labeled dosing for CD3 IV doses

Authorization will be issued for 3 induction doses

No concurrent systemic targeted immunomodulator: Patient is not receiving Tremfya in combination with another systemic targeted immunomodulator for treatment of the same indication

Examples of systemic targeted immunomodulators are listed in policy (e.g., adalimumab, vedolizumab, risankizumab, ustekinumab, upadacitinib)

Prior therapy requirement:

Evidence-based coverage considerations

Clinical trial evidence and policy revisions informing coverage:

Induction efficacy (UC1): In 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 rates as reported

Supports induction efficacy

Maintenance efficacy (UC2): In UC2, clinical remission at Week 44 was 45% with Tremfya 100 mg, 50% with Tremfya 200 mg, and 19% with placebo; both doses significantly exceeded placebo.Week 44 remission rates as reported

Supports maintenance efficacy

Prior therapy considerations: Coverage criteria were revised to require prior treatment with a systemic targeted immunomodulator FDA-approved for ulcerative colitis/Crohn's disease in specified circumstances.

Use of Tremfya in combination with another systemic targeted immunomodulator for treatment of the same indication is excluded from coverage. The policy lists examples of systemic targeted immunomodulators that are not permitted concurrently (e.g., adalimumab, certolizumab, etanercept, vedolizumab, upadacitinib, risankizumab, ustekinumab, tofacitinib, among others). This restriction applies to both ulcerative colitis and Crohn's disease induction dosing and is an operational requirement for authorization decisions.

Combination with non-systemic agents or agents used for a different indication may be evaluated differently; see the member specific benefit plan and policy application notes for operational details.

Coverage decisions are subject to the terms of the member specific benefit plan document. Some Certificates of Coverage permit coverage of experimental, investigational, or unproven treatments for life‑threatening illnesses under defined conditions; conversely, other plans may expressly exclude such uses. Always consult the member specific benefit plan to determine whether Tremfya is a covered benefit for the requested indication.

State or federal mandates that require coverage for off‑label uses or other circumstances supersede the member specific benefit document where applicable. In the event of conflict between this policy and the member specific benefit plan, the member specific benefit plan governs.

Intravenous Tremfya induction is authorized only when administered as three IV induction doses consistent with the U.S. FDA labeled induction regimen; prior authorization will be issued for three induction doses when criteria are met.

Administration of Tremfya outside the authorized three IV induction doses or administration in combination with another systemic targeted immunomodulator for the same indication does not meet the policy criteria and will not be authorized.

If the member's specific benefit plan does not permit coverage of experimental, investigational, or unproven treatments, or if Tremfya use falls outside the plan's defined coverage criteria, the request may be denied. Providers should verify plan coverage and any applicable state or federal mandates prior to submission.

This policy is intended to assist in interpreting UnitedHealthcare standard benefit plans and may be applied to Medicare Advantage where allowed; however, the member specific benefit plan document governs coverage in the event of differences.

Coding and Clinical Metrics

Applicable HCPCS/NDCHCPCS

J1628

Injection, guselkumab, 1 mg

National Drug CodeNDC

57894-0650-02

How Supplied: 200 mg/ 20 mL vial

Applicable 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

modified Mayo score severe disease threshold

Severe disease thresholdmMS ≥ 7 indicates severely active disease

mMS scaleModified Mayo score range 0–9 (three components: stool frequency, rectal bleeding, endoscopy)

UC1 baseline medianMedian mMS at baseline in UC1 was 7

Provider Requirements and Authorization

Prior Authorization

Prior authorization for IV induction — 3 induction doses authorized

Prior authorization is required for intravenous Tremfya; when criteria are met, authorization will be issued for three induction doses.

HCPCS: J1628 (injection, guselkumab, 1 mg) referenced for billing

Prior Authorization

Prior authorization required per plan — Commercial & Individual Exchange

This policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans; submit prior authorization consistent with the member specific benefit plan and policy criteria.

Policy transferred to shared template covering Commercial and Individual Exchange plans
Check member specific benefit document for plan differences and applicable mandates

Background on Tremfya (guselkumab)

Tremfya (guselkumab) is a human monoclonal IgG1λ antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting IL‑23 signaling and downstream proinflammatory cytokine release. The policy references Phase 3 induction trials supporting intravenous induction dosing for both moderately to severely active ulcerative colitis and Crohn's disease.

For coverage purposes, Tremfya is considered a provider‑administered (intravenous) medication for induction in inflammatory bowel disease; prior authorization and dosing restrictions described elsewhere in this policy apply to intravenous use.

Key Definitions

Modified Mayo score (mMS)

DefinitionModified Mayo score (mMS) is a 3-component Mayo score (0–9) consisting of stool frequency, rectal bleeding, and centrally reviewed endoscopy subscores

Component subscoresEach component scored 0–3: stool frequency (SFS), rectal bleeding (RBS), endoscopy (ES)

Endoscopy descriptorsES 2: marked erythema, loss of vascular pattern, friability, and/or erosions; ES 3: spontaneous bleeding and ulceration

mMS 5–9 indicates moderately to severely active disease

Moderately to severely active rangemMS 5–9 with endoscopic subscore 2 or 3 indicates moderately to severely active ulcerative colitis

Enrollment criterion in UC1Enrolled subjects had mMS between 5 and 9 and ES of 2 or 3

Policy Summary

PayerUnitedHealthcare

PolicyTremfya (guselkumab) — Intravenous for Ulcerative Colitis and Crohn's Disease

Policy CodePolicy 2026D0134D

Change TypeCriteria revised — combination restriction and prior systemic targeted immunomodulator requirement

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization for intravenous Tremfya; authorization will be issued for three induction IV doses when policy criteria are met.

SourceLink

On This Page

Either history of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated: corticosteroids (e.g., prednisone), 6-mercaptopurine, azathioprine, or methotrexate; OR prior treatment with a systemic targeted immunomodulator FDA-approved for the treatment of Crohn's disease

Conventional therapy must be up to maximally indicated doses unless contraindicated

Specialist involvement: Prescribed by or in consultation with a gastroenterologist

prior systemic targeted immunomodulator

See policy criteria for specifics

Combination therapy limitation: Policy revised to prohibit use of Tremfya in combination with another systemic targeted immunomodulator for treatment of the same indication.no concurrent systemic targeted immunomodulator for same indication

Operational restriction

Step Therapy

Prior therapy requirement — inadequate response to corticosteroids/immunosuppressants

For both ulcerative colitis and Crohn's disease, one coverage pathway requires prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine).

Examples of conventional therapies: corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate
Therapy should be used at maximally indicated doses unless contraindicated

Step Therapy

Prior systemic targeted immunomodulator required — revised prior‑therapy criterion

Coverage criteria were revised to require prior treatment with a systemic targeted immunomodulator FDA‑approved for ulcerative colitis or Crohn's disease in specified circumstances.

Policy language specifies 'systemic targeted immunomodulator' (examples in policy include adalimumab, vedolizumab, upadacitinib, risankizumab, ustekinumab, tofacitinib)
Prior systemic targeted immunomodulator is an alternative pathway to conventional therapy failure

Documentation Required

Specialist involvement — gastroenterologist required

Prescribed by or in consultation with a gastroenterologist is required for medical necessity determinations for UC and CD.

Documentation should indicate the gastroenterologist's involvement (prescribing or consult)

Documentation Required

Member-specific benefit document required — verify plan terms and mandates

Reference the member specific benefit plan document when deciding coverage; the member specific document governs and may include federal or state mandates that affect coverage.

Check for applicable federal or state mandates and any Medicare NCD/LCD guidance
In event of conflict, the member specific benefit plan controls

Denial Risk

Concurrent targeted immunomodulator exclusion — no combination systemic targeted therapy

Use of Tremfya in combination with another systemic targeted immunomodulator for the same indication will not meet criteria for authorization.

Examples listed in policy include adalimumab, vedolizumab, upadacitinib, risankizumab, ustekinumab, tofacitinib and others
Combination restriction applies specifically to systemic targeted immunomodulators for the same indication

Denial Risk

Benefit limitations may trigger denial — check plan coverage for experimental/investigational treatments

Coverage may be denied if the member's benefit plan does not allow coverage of experimental, investigational, or unproven treatments or if state/federal mandates do not require coverage.

Some Certificates of Coverage permit coverage of experimental/investigational treatments for life‑threatening illnesses—verify the member's certificate
If the plan excludes such treatments, Tremfya use may be considered not medically necessary

Proportion with severe diseaseAt baseline in UC1, 64% of subjects had severely active disease (mMS ≥ 7)