GUSELKUMAB INJ,SOLN

Generic Name: GUSELKUMAB INJ
Brand Names: TREMFYA, TREMFYA ONE-PRESS, TREMFYA PEN, TREMFYA PEN INDUCTION (2 PEN)
Drug Class: IMMUNE SUPPRESSANTS
Formulary Status: N
Copay Tier: 3
Last Updated: 2017-09-01

Clinical Criteria Summary

Document 199

Exclusion Criteria

Active, serious, systemic or localized infection, including undrained abscess (may start/restart once controlled)
Untreated latent or active tuberculosis infection
Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting prophylaxis)
HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive and not on antiviral prophylaxis (may initiate after starting prophylaxis)
Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients can be treated)
Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
General Inclusion Criteria (All must be met)
Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated psoriasis expert
Prescribed at the FDA-approved dose for plaque psoriasis
Adult with chronic (≥ 6 months) moderate to severe plaque psoriasis (including involvement of nails only)
Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
Completed hepatitis B screening (at minimum, 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 results)
For patients who can become pregnant and partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
Prior Therapy Requirements (All must be met)
Methotrexate monotherapy is medically inadvisable, not tolerated, or not adequate (i.e., NO treatment benefit after 3 months, of which at least 2 months is at the standard target dose), or inadequate partial response after 6 months
Phototherapy is medically inadvisable, not available, not feasible, or inadequate (i.e., NO treatment benefit after 12 treatments or inadequate partial response after 24 treatments)
Tumor necrosis factor inhibitor (TNFI) therapy is medically inadvisable, not tolerated, or not adequate (i.e., NO response to ONE TNFI after 3 months, partial response to 3-month trials of TWO TNFIs = total 6 months, or loss of initial response)
Additional Biologic Failure/Inadvisability Criteria (One must be met)
Interleukin-17A inhibitor (i.e., ixekizumab [preferred] or secukinumab) is medically inadvisable, not tolerated or not adequate (i.e., NO response after 12 weeks, inadequate partial response after 24 weeks, or loss of initial response)
Ustekinumab is medically inadvisable, not tolerated or not adequate (i.e., NO response after 16 weeks, inadequate partial response after 32 weeks, or loss of initial response)

Document 367

Indication & Diagnosis

Definite or provisional diagnosis of psoriatic arthritis
Inflammatory articular disease (joint, spine, and/or entheseal)

Prior Therapy Requirements

One tumor necrosis factor inhibitor (TNFI) must be medically inadvisable, not tolerated, or not adequate (defined as no/partial response after 12 weeks or loss of initial response)
One interleukin-17A inhibitor (IL-17AI; ixekizumab [preferred] or secukinumab) must be medically inadvisable, not tolerated, or not adequate (defined as no response after 12 weeks, inadequate partial response after 24 weeks, or loss of initial response)
Methotrexate monotherapy must be medically inadvisable, not tolerated, or not adequate (defined as no treatment benefit after 3 months with at least 2 months at standard target dose, or inadequate partial response after 6 months; target dose: 15–25 mg once weekly orally, subcutaneously, or intramuscularly)
Phototherapy must be medically inadvisable or inadequate (defined as no treatment benefit after 12 treatments or inadequate partial response after 24 treatments)

Infection Screening & Management

Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
Completed hepatitis B screening (at minimum: HBsAg, total anti-HBc, and anti-HBs)
Current or past completion of hepatitis C screening (initiation may occur while awaiting results)
Antiviral prophylaxis is required for patients with active HBV infection or those who are HBsAg-negative but anti-HBc-positive; initiation may proceed after starting prophylaxis

Contraindications & Exclusions

Active, serious, systemic, or localized infection (including undrained abscess); therapy may start/restart once infection is controlled
Untreated latent or active tuberculosis infection
Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients are eligible)
Concomitant live or live-attenuated vaccines, or administration of inactivated/live/attenuated vaccines less than 2 weeks before initiation
TNFI may be medically inadvisable for heart failure, demyelinating disease, multiple sclerosis in a first-degree relative, lupus, recurrent infections, or serious infections
IL-17A inhibitors may be medically inadvisable for Crohn’s disease, ulcerative colitis, or recurrent/severe Candida infections

Monitoring, Counseling & Administration

Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist, or locally designated expert
Administered at the FDA-approved dose for psoriatic arthritis
For patients who can become pregnant or whose partners can become pregnant: counseling on potential risks vs benefits and use of effective contraception is required

Document 715

Disease Indication & Diagnosis

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

Infection Screening & Laboratory Requirements

Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
Completed hepatitis B screening (at minimum: 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 (initiation permitted while awaiting results)
Obtained liver panel including bilirubin

Exclusion Criteria

Uncontrolled, active, severe infection including evidence of C. difficile and undrained abscess (may start/restart once treatment initiated)
Untreated latent or active tuberculosis infection
Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting prophylaxis)
Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients are eligible)
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 determines potential benefits outweigh risks

Prior Therapy Requirements

One of the following must be tried (unless medically inadvisable) and found not tolerated, not adequate, or lost response: vedolizumab, tofacitinib, upadacitinib, etrasimod, or ozanimod
Risankizumab-rzaa must be tried (unless medically inadvisable) and found not tolerated, not adequate, or lost response

Additional Inclusion Criteria (One Required)

Tumor necrosis factor inhibitor (TNFI) is medically inadvisable (infliximab / biosimilar is the 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 / biosimilar preferred) despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure

Special Populations & Expert Consultations

If HBsAg-negative but anti-HBc-positive: GI / liver or infectious diseases expert consulted for advice on antiviral prophylaxis vs preemptive monitoring for HBV reactivation
Women who can become pregnant: Counseling provided on treatment risks vs benefits and use of effective contraception

Sequencing & Retesting Policies

1L therapy: Infliximab (preferred) or adalimumab
2L / 3L therapy: Vedolizumab, tofacitinib, upadacitinib, etrasimod, ozanimod, or risankizumab-rzaa (one must be risankizumab-rzaa)
4L therapy: Mirikizumab-mrkz, guselkumab, or ustekinumab
Routine retesting for TB, hepatitis B, and hepatitis C screening is not required for prescription renewals; retesting in high-risk patients should be considered
Applies only to new starts; stable patients should not be switched to a criteria-required prior agent for nonmedical reasons

Document 716

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

Exclusion Criteria

Uncontrolled, active, severe infection (may start/restart once infection treatment 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)
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

Inclusion Criteria (All Required)

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
Completed tuberculosis 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
One of vedolizumab or upadacitinib was tried (unless medically inadvisable) and not tolerated, not adequate, or lost response
Risankizumab-rzaa was tried (unless medically inadvisable) and not tolerated, not adequate, or lost response

Additional Inclusion Criteria (One Required)

Tumor necrosis factor inhibitor (TNFI) is medically inadvisable
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-based optimized dosing to address pharmacokinetic failure

Additional Clinical Requirements

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

Drug Sequencing & Positioning

First-line (1L): Infliximab/biosimilar or adalimumab/biosimilar; vedolizumab may be used 1L for “moderate” CD, absence of extraintestinal manifestations, or pouchitis
Second/Third-line (2L/3L): Vedolizumab, upadacitinib, or risankizumab-rzaa (one drug must be risankizumab-rzaa)
Fourth-line (4L): Mirikizumab-mrkz, guselkumab, or ustekinumab/biosimilar

Testing & Monitoring Guidelines

Routine retesting for tuberculosis, hepatitis B, and hepatitis C is not required for prescription renewals; retesting in high-risk patients should be considered
Anti-HBs titers >= 10 IU/L are generally considered protective

Source Documents

Document 199 Document 367 Document 715 Document 716 Document 745