VA Criteria for Use Formulary Advisor Reference
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TILDRAKIZUMAB-ASMN INJ,SOLN

Generic Name
TILDRAKIZUMAB-ASMN INJ
Brand Names
ILUMYA
Drug Class
IMMUNOLOGICAL AGENTS,OTHER
Formulary Status
Non-Formulary Requires prior authorization
Copay Tier
3
Last Updated
June 1, 2026

Clinical Criteria Summary

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

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)

Additional Inclusion Criteria (Prior Therapy Requirements)

  • ONE of the following must be met:
  • Methotrexate monotherapy is medically inadvisable, not tolerated, not adequate, or lost response (patients on targeted immunomodulators are NOT required to backstep to methotrexate)
  • Tumor necrosis factor inhibitor (TNFI) is medically inadvisable, not tolerated, not adequate, or lost response
  • Ustekinumab is medically inadvisable, not tolerated, not adequate, or lost response

Screening & Monitoring Requirements

  • 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 whether to start antiviral prophylaxis or to preemptively monitor for HBV reactivation
  • Routine rescreening is not required for prescription renewals (retesting in high-risk patients should be considered)

Special Populations & Counseling

  • Females who can become pregnant: counseling provided on potential risks vs benefits of treatment and the use of effective contraception
  • Females who are breastfeeding/providing breastmilk to an infant: counseling provided on potential risks vs benefits of treatment

Treatment Sequencing Guidelines

  • 1L: Methotrexate, 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
  • Applies to new starts only; stable patients on treatment should not be switched to a criteria-required prior treatment for nonmedical reasons

Source Documents

Download CFU PDF: Tildrakizumab ILUMYA in Plaque Psoriasis Criteria