BRODALUMAB INJ,SOLN

Clinical Criteria Summary

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
History of suicidal ideation or behavior or risk factors for suicide (e.g., depression, bipolar disorder) – relative contraindication; available only through the restricted SILIQ REMS Program
Crohn’s disease

Meets requirements of the SILIQ REMS Program
Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated psoriasis expert
Prescribed at the FDA-approved dose for plaque psoriasis
Chronic (≥ 6 months) moderate to severe plaque psoriasis (including involvement of nails only)

TWO interleukin-17 inhibitors (ixekizumab [preferred] and secukinumab) are medically inadvisable, not tolerated or not adequate (i.e., NO response after 12 weeks, inadequate partial response after 24 weeks, or lost response)
ONE of the following must also 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

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)
If at risk: completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]

Offered all age-appropriate vaccinations prior to initiating therapy
When possible, vaccinations should be updated before initiation; recombinant zoster (SHINGRIX) vaccine should be completed or at least initiated by the end of the first year of treatment, preferably when dosage is low, disease is stable, or at other times when a robust immune response can be expected

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

Standard sequencing: 1L (Methotrexate, TNFi or ustekinumab ± phototherapy) → 2L (Interleukin-17A inhibitor; ixekizumab preferred over secukinumab) → 3L (Interleukin-23 inhibitor) → 4L (Bimekizumab-bkzx) → Other (Apremilast, deucravacitinib, brodalumab)
An interleukin-17A inhibitor (ixekizumab preferred) may be used as 1L if psoriasis is severe
Applies to new starts only; stable patients should not be switched for nonmedical reasons
Methotrexate response: NO treatment benefit after 3 months (at least 2 months at standard target dose of 15–25 mg ONCE WEEKLY orally, subcutaneously, or intramuscularly); or inadequate partial response after 6 months
TNFi response: NO or partial response after 3 months or loss of initial response
Ustekinumab response: NO response after 16 weeks, inadequate partial response after 32 weeks, or loss of initial response