TILDRAKIZUMAB-ASMN INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Active, serious, systemic or localized infection, including undrained abscess (may be started/restarted once the infection is controlled)
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may be initiated after starting antiviral prophylaxis)
- HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive and not on antiviral prophylaxis (may be initiated 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
Inclusion Criteria
- 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 be initiated while waiting for test results)
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
- Methotrexate monotherapy is medically inadvisable, not tolerated, or not adequate
- Phototherapy is medically inadvisable, inadequate, not available or not feasible
- 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 Inclusion Criteria
- ONE of the following criteria 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)