CurrentUnitedHealthcarePolicy IEXD00134.02

Tremfya (guselkumab) IV — Induction therapy for moderately to severely active ulcerative colitis and Crohn's disease

Defines UnitedHealthcare medical benefit coverage criteria for intravenous Tremfya (guselkumab) used as induction therapy for moderately to severely active ulcerative colitis and Crohn's disease under the medical benefit.

Policy Summary

PayerUnitedHealthcare

PolicyTremfya (guselkumab) IV — Induction therapy for moderately to severely active ulcerative colitis and Crohn's disease

Policy CodePolicy IEXD00134.02

Change TypeRoutine review — no material changes

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documenting diagnosis, prior therapy history, and request for three IV induction doses; authorization will be issued for three induction doses when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3authorized induction doses

J1628HCPCS

200 mg/20 mLNDC

701UC trial N

Coverage Criteria for Intravenous Tremfya (guselkumab)

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Ulcerative Colitis — Initial Induction

Covered when ALL of the following are met

UC - diagnosis: Diagnosis of moderately to severely active ulcerative colitis

UC - prior therapy: Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine) OR patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of ulcerative colitis (examples: adalimumab, vedolizumab, mirikizumab, upadacitinib, golimumab, risankizumab, ustekinumab, tofacitinib)

UC - dosing and combination: Tremfya is to be administered as three intravenous induction doses in accordance with the U.S. FDA labeled dosing for ulcerative colitis AND patient is not receiving Tremfya in combination with another targeted immunomodulator

Authorization will be issued for 3 induction doses

UC - prescriber: Prescribed by or in consultation with a gastroenterologist

Crohn's Disease — Initial Induction

Covered when ALL of the following are met

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

CD - prior therapy: History of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated or intolerable: corticosteroids (e.g., prednisone, methylprednisolone, budesonide), 6-mercaptopurine, azathioprine, or methotrexate OR patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of Crohn's disease (examples: adalimumab, certolizumab, vedolizumab, mirikizumab, upadacitinib, risankizumab, ustekinumab)

CD - dosing and combination: Tremfya is to be administered as three intravenous induction doses in accordance with the U.S. FDA labeled dosing for Crohn's disease AND patient is not receiving Tremfya in combination with another targeted immunomodulator

Authorization will be issued for 3 induction doses

CD - prescriber:

Use of Tremfya (guselkumab) in combination with another targeted immunomodulator is excluded and will not be authorized concurrently. Examples of targeted immunomodulators not permitted for concurrent use include, but are not limited to, adalimumab, certolizumab (Cimzia), etanercept (Enbrel), vedolizumab (Entyvio), baricitinib (Olumiant), mirikizumab (Omvoh), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), ustekinumab (Stelara), and tofacitinib (Xeljanz).

Self-administered subcutaneous formulations of Tremfya (guselkumab) are to be obtained under the pharmacy benefit. This medical benefit policy applies to the intravenous formulation only.

Coding — HCPCS, NDC, and Diagnosis Codes

Covered HCPCSHCPCSCovered

J1628

Injection, guselkumab, 1 mg

NDCNDC

57894-0650-02

200 mg/ 20 mL vial

Listed ICD-10 Codes (Crohn's & Ulcerative colitis)ICD-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

mMS severe disease threshold

Severe disease thresholdModified Mayo score (mMS) ≥ 7 indicates severely active ulcerative colitis (64% of UC1 subjects had mMS ≥ 7).

mMS range for enrollmentEnrolled subjects in UC1 had mMS between 5 and 9.

Use in trial classificationSubjects with mMS between 5–9 plus endoscopy subscore (ES) 2 or 3 were classified as moderately to severely active disease.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required — authorization issued for 3 IV induction doses

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

HCPCS J1628 applies for guselkumab injection (1 mg).

Step Therapy

Prior therapy requirement — inadequate response or prior targeted immunomodulator

Members must have an inadequate response to, or history of failure/intolerance to, conventional therapies or have been previously treated with an FDA‑approved targeted immunomodulator for the disease prior to authorization.

Conventional therapies listed for UC include oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine).
Conventional therapies listed for CD include corticosteroids, 6‑mercaptopurine, azathioprine, or methotrexate.
Alternatively, prior treatment with a targeted immunomodulator FDA‑approved for the relevant disease fulfills the requirement.

Documentation Required

Required documentation — diagnosis, prior therapy, dosing and prescriber

Clinical documentation must demonstrate the diagnosis, prior therapy history (inadequate response, failure, or intolerance), and supportive treatment details consistent with three IV induction doses and specialty involvement.

Document diagnosis of moderately to severely active ulcerative colitis or Crohn's disease.
Document prior or concurrent inadequate response to listed conventional therapies or prior targeted immunomodulator treatment.
Document that Tremfya will be administered as three IV induction doses per FDA‑labeled dosing and that treatment is prescribed by or in consultation with a gastroenterologist.

Denial Risk

Triggers for denial — missing diagnosis, prior‑therapy evidence, or concurrent biologic use

Requests may be denied if they do not document a diagnosis of moderately to severely active UC or CD, lack evidence of required prior/concurrent inadequate response or prior targeted immunomodulator therapy, or request combination use with another targeted immunomodulator.

Combination use with another targeted immunomodulator is excluded and may lead to denial.
Lack of documentation showing inadequate response/failure/intolerance to the specified conventional therapies or prior targeted immunomodulator may result in denial.

Definitions

Tremfya (guselkumab)

Generic nameGuselkumab (brand name: Tremfya).

Molecular classHuman monoclonal IgG1λ antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23).

Mechanism of actionBinds IL‑23 p19 subunit and inhibits interaction with the IL‑23 receptor, reducing IL‑23–mediated release of proinflammatory cytokines and chemokines.

Modified Mayo score (mMS)

ComponentsThree components: stool frequency subscore (SFS), rectal bleeding subscore (RBS), and centrally reviewed endoscopy subscore (ES).

Scoring rangeTotal mMS ranges from 0 to 9, with each subscore scored 0–3.

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

Trial useIn UC1, disease activity was assessed by mMS; enrolled subjects had mMS 5–9 and an ES of 2 or 3.