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GUSELKUMAB INJ,SOLN NEW

Generic Name
GUSELKUMAB INJ
Brand Names
TREMFYA, TREMFYA ONE-PRESS, TREMFYA PEN, TREMFYA PEN INDUCTION (2 PEN)
Drug Class
IMMUNE SUPPRESSANTS
Formulary Status
Non-Formulary Requires prior authorization
Copay Tier
3
Last Updated
August 1, 2026

Clinical Criteria Summary

Document 199: Guselkumab TREMFYA in Psoriasis Criteria

Exclusion Criteria

  • Active infection (may start/restart once treatment for the infection is initiated)
  • Untreated latent or active tuberculosis infection
  • Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
  • Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
  • Congenital or acquired immunodeficiency
  • Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation

Core Inclusion Criteria

  • Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated psoriasis expert
  • Chronic (≥ 6 months) moderate to severe plaque psoriasis (including involvement of nails only)
  • Offered all age-appropriate vaccinations prior to initiating therapy
  • Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
  • Current or past completion of hepatitis C screening (may initiate while waiting for test results)
  • Interleukin-17A inhibitor (ixekizumab preferred or secukinumab) is medically inadvisable, not tolerated, or not adequate (NO response after 12 weeks, inadequate partial response after 24 weeks, or lost response)

Prior Therapy Requirements (Select One)

  • Methotrexate monotherapy is medically inadvisable, not tolerated, not adequate (NO treatment benefit after 3 months, of which at least 2 months is at the standard target dose), or lost response
  • Tumor necrosis factor inhibitor (TNFI) is medically inadvisable, not tolerated, not adequate (NO or partial response after 3 months), or lost response
  • Ustekinumab is medically inadvisable, not tolerated, not adequate (NO response after 16 weeks), or lost response

Additional Clinical Requirements & Counseling

  • If patient is at risk, completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • If HBsAg-negative but anti-HBc-positive and consult deemed indicated, GI/liver or infectious diseases expert has been consulted for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
  • For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception
  • For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits of treatment

Sequencing Guidelines

  • 1L: Methotrexate or TNFi or ustekinumab (± phototherapy)
  • 2L: Interleukin-17A inhibitor (ixekizumab preferred over secukinumab)
  • 3L: Interleukin-23 inhibitor (e.g., guselkumab, risankizumab, tildrakizumab)
  • 4L: Bimekizumab
  • Other: Apremilast, deucravacitinib, brodalumab
  • An interleukin-17A inhibitor (ixekizumab preferred) may be used 1L if psoriasis is severe

Monitoring & Renewal Notes

  • Applies to new starts only; stable patients should not be switched for nonmedical reasons
  • Routine rescreening is not required for prescription renewals; retesting in high-risk patients should be considered
  • Antiviral prophylaxis for HBV should use agents with a high genetic barrier to resistance (e.g., entecavir or tenofovir)
  • Vaccinations should be updated before initiation; recombinant zoster vaccine should be completed or at least initiated by the end of the first year of treatment if not contraindicated

Document 367: Guselkumab TREMFYA in Psoriatic Arthritis Criteria

Exclusion Criteria

  • Active infection (may start/restart once treatment for the infection is initiated)
  • Untreated latent or active tuberculosis infection
  • Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
  • Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients can be treated)
  • Congenital or acquired immunodeficiency
  • Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation

Inclusion Criteria

  • Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist, or locally designated expert
  • Inflammatory articular disease (joint, spine, and/or entheseal) with a definite or provisional diagnosis of psoriatic arthritis
  • Offered all age-appropriate vaccinations prior to initiating therapy
  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • Completed hepatitis B screening (HBsAg, total anti-HBc, and antibody to hepatitis B surface antigen [anti-HBs])
  • Current or past completion of hepatitis C screening (may initiate while waiting for test results)
  • One tumor necrosis factor inhibitor (TNFI) is medically inadvisable, not tolerated, not adequate after 3 months, or lost response
  • One IL-17AI (i.e., ixekizumab [preferred] or secukinumab) is medically inadvisable, not tolerated or not adequate

Additional Inclusion Criteria

  • If HBsAg-negative but anti-HBc-positive and consult deemed indicated: GI/liver or infectious diseases expert consulted for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
  • For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception
  • For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits

Screening, Monitoring & Clinical Context Guidelines

  • Routine rescreening is not required for prescription renewals; retesting in high-risk patients should be considered
  • Applies to new starts only; stable patients who responded to induction and/or controlled on maintenance therapy should not be switched for nonmedical reasons
  • Clinician should use guidance and interpret in the clinical context of the individual patient; exceptions adjudicated locally per P&T committee policy

Document 715: Guselkumab TREMFYA in Ulcerative Colitis Criteria

Exclusion Criteria

  • Active infection (may be started/restarted once treatment for the infection is initiated)
  • Untreated latent or active tuberculosis infection
  • Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
  • Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
  • Congenital or acquired immunodeficiency
  • Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
  • Liver cirrhosis unless prescriber deems potential benefits outweigh risks

Core Inclusion Criteria (All Must Be Met)

  • Current or prior moderate to severe ulcerative colitis (UC) confirmed by endoscopy or imaging
  • Prescribed and monitored by a VA/VA Community Care gastroenterologist/hepatologist or locally designated expert
  • Offered all age-appropriate vaccinations prior to initiating therapy
  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
  • Completed hepatitis B screening (HBsAg, total antibody-to-hepatitis-B-core-antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
  • Current or past completion of hepatitis C screening (may initiate while waiting for test results)
  • Obtained liver panel including bilirubin
  • Medical inadvisability, primary nonresponse, inadequate partial response, or loss of response after 8 weeks (single IV induction dose) or 16 weeks (if using second IV induction dose) of ustekinumab

Additional Inclusion Criteria (One Must Be Met)

  • Tumor necrosis factor inhibitor (TNFI) is medically inadvisable (Infliximab is preferred TNFI in UC)
  • Primary nonresponse, inadequate partial response, or loss of response after 12 weeks of one TNFI in the presence of adequate TNFI levels (mechanistic failure)
  • Loss of response to a TNFI (infliximab preferred) despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure

Conditional/Additional Requirements

  • If HBsAg-negative but anti-HBc-positive and consult deemed indicated: GI/liver or infectious diseases expert consulted for advice on starting antiviral prophylaxis vs preemptive monitoring for HBV reactivation
  • For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception
  • For females breastfeeding/providing breastmilk: Counseling provided on potential risks vs benefits of treatment

Sequencing & Clinical Management

  • Applies only to new starts; stable patients should not be switched to a criteria-required prior agent for nonmedical reasons
  • Routine retesting is not required for prescription renewals; consider in high-risk patients
  • Vaccinations should be updated before initiation; recombinant zoster vaccine should be completed or initiated by end of first year, preferably when dosage is low, disease is stable, or immune response can be expected
  • Loss of response refers to active disease confirmed by endoscopy, imaging, or biochemical assessment
  • Sequencing: 1L includes infliximab (preferred), adalimumab, ustekinumab, or vedolizumab. 2L includes TNFI or ustekinumab if not previously used. 3L includes vedolizumab, tofacitinib/upadacitinib after TNFi, guselkumab, risankizumab, etrasimod, or ozanimod. 4L is mirikizumab
  • Severe UC may require earlier escalation to 3L therapies after initial TNFI failure; decisions should be made collaboratively by IBD prescriber and pharmacy

Document 716: MON Guselkumab TREMFYA in Ulcerative Colitis Monograph Feb 2025

Indication

  • Treatment of adults with moderately to severely active ulcerative colitis (UC)

Dosing & Administration

  • Induction: 200 mg IV infusion over at least one hour at Weeks 0, 4, and 8
  • Maintenance: Either 100 mg SC at Week 16 then every 8 weeks, or 200 mg SC at Week 12 then every 4 weeks

Therapeutic Placement & Guideline Recommendations

  • Placed as early as second-line (2L) therapy per VA/Clinical Guidance
  • Not specifically mentioned in 2020 AGA or 2019 ACG guidelines; FDA-approved for UC in September 2024

Patient Selection Criteria

  • Inadequate response (IR), loss of response (LOR), secondary nonresponse (SNR), primary nonresponse (PNR), or intolerance (INT) to corticosteroids (CS), immunomodulators (IMM), and/or advanced tx
  • Advanced tx include ≥1 TNFi, vedolizumab (VEDO), and/or JAKi (tofacitinib/TOFA)
  • Guselkumab monotherapy may be used for induction and maintenance in patients with medical inadvisability, IR, INT, or LOR to a TNFi, plus two of the following: vedolizumab, tofacitinib, upadacitinib, etrasimod, ozanimod, or risankizumab (one must be risankizumab)

Combination Therapy Considerations

  • Guselkumab is the first IL-23i evaluated in combination with a TNFi (golimumab) versus monotherapy
  • Combination induction followed by guselkumab monotherapy maintenance may be considered on a case-by-case basis
  • Golimumab is noted as currently the costliest TNFi; safety and efficacy of other TNFis combined with guselkumab have not been evaluated

Document 745: Guselkumab TREMFYA in Crohns Disease Criteria

Exclusion Criteria

  • Active infection (may initiate/restart once treatment for the infection has been initiated)
  • Untreated latent or active tuberculosis infection
  • Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
  • Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
  • Congenital or acquired immunodeficiency
  • Concomitant live or live-attenuated vaccines, or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
  • Liver cirrhosis unless potential benefits outweigh risks based on shared decision-making

General Inclusion Criteria

  • Current or prior moderate to severe Crohn’s disease (CD) confirmed by endoscopy or imaging
  • Prescribed and monitored by a VA / VA Community Care gastroenterologist or locally designated expert
  • Offered all age-appropriate vaccinations prior to initiating therapy
  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • Completed hepatitis B screening (HBsAg, total antibody-to-hepatitis-B-core-antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
  • Current or past completion of hepatitis C screening (may initiate while waiting for test results)
  • Obtained liver panel including bilirubin
  • Ustekinumab is medically inadvisable, not tolerated, or not adequate, or lost response

Therapy History & Sequencing Requirements

  • ONE of the following must be met:
  • Tumor necrosis factor inhibitor (TNFI) is medically inadvisable (Infliximab/biosimilar and adalimumab/biosimilar are preferred TNFIs in CD)
  • Primary nonresponse, inadequate partial response, or loss of response after 12 weeks of one TNFI in the presence of adequate TNFI levels (mechanistic failure)
  • Loss of response to a TNFI despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure
  • Applies only to new starts; stable patients should not be switched to a criteria-required prior agent for nonmedical reasons
  • Sequencing: 1L = Infliximab, adalimumab, or ustekinumab (Vedolizumab may be used 1L for moderate CD, absence of extraintestinal manifestations, or pouchitis); 2L = TNFI (if not previously used) or ustekinumab (if not previously used); 3L = Vedolizumab, upadacitinib, guselkumab, or risankizumab
  • Certain patients with severe CD may require earlier escalation to 3L therapies after initial TNFI failure

Special Populations & Consultation Requirements

  • If HBsAg-negative but anti-HBc-positive and consult is deemed indicated: A GI/liver or infectious diseases expert has been consulted for advice on whether to start antiviral prophylaxis or to preemptively monitor for HBV reactivation
  • For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
  • For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits of treatment

Source Documents

Document 199: Guselkumab TREMFYA in Psoriasis Criteria Document 367: Guselkumab TREMFYA in Psoriatic Arthritis Criteria Document 715: Guselkumab TREMFYA in Ulcerative Colitis Criteria Document 716: MON Guselkumab TREMFYA in Ulcerative Colitis Monograph Feb 2025 Document 745: Guselkumab TREMFYA in Crohns Disease Criteria