BRODALUMAB INJ,SOLN
Clinical Criteria Summary
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
- HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive and not on antiviral 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
- History of suicidal ideation or behavior or risk factors for suicide (e.g., depression, bipolar disorder) – relative contraindication when potential risks outweigh benefits; available only through the restricted SILIQ REMS Program
- Crohn’s disease
Inclusion Criteria for Plaque Psoriasis
- Meets requirements of the SILIQ REMS Program
- Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated psoriasis expert
- Prescribed at 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
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits and use of effective contraception
- Methotrexate monotherapy is medically inadvisable, not tolerated, or not adequate (inadequate response defined as NO treatment benefit after 3 months with at least 2 months at standard target dose [15–25 mg ONCE WEEKLY], or inadequate partial response after 6 months)
- Phototherapy is medically inadvisable, inadequate, not available or not feasible (inadequate defined as NO treatment benefit after 12 treatments or inadequate partial response after 24 treatments; medically inadvisable for confirmed history of skin cancer/melanoma or strong likelihood [Fitzpatrick I/II])
- Tumor necrosis factor inhibitor (TNFI) therapy is medically inadvisable, not tolerated, or not adequate (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; may be inadvisable for heart failure, demyelinating disease, multiple sclerosis in first-degree relative, lupus, recurrent infections, serious infections)
- 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 loss of initial response; may be inadvisable for Crohn’s disease, ulcerative colitis, or recurrent/severe Candida infections)
- Interleukin-23 inhibitor (e.g., guselkumab, risankizumab-rzaa, or tildrakizumab-asmn) is medically inadvisable, not tolerated or not adequate (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 (NO response after 16 weeks, inadequate partial response after 32 weeks, or loss of initial response; may be inadvisable for history of noninfectious pneumonia)