IXEKIZUMAB INJ,SOLN
Clinical Criteria Summary
Document 208
Infection Screening & Management
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA].
- Completed hepatitis B screening (HBsAg, total anti-HBc and antibody to hepatitis B surface antigen [anti-HBs]).
- Current or past completion of hepatitis C screening.
- If HBsAg-negative but anti-HBc-positive: GI/liver or ID expert consult indicated for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation.
Contraindications & Exclusions
- Uncontrolled, active, severe infection, including undrained abscess (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 with agents such as entecavir or tenofovir).
- 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.
Diagnosis & Indication
- Definite or provisional diagnosis of active ankylosing spondylitis (or radiographic axial spondyloarthritis).
Prescribing & Monitoring Requirements
- Prescribed and monitored by a VA/VA Community Care rheumatologist or locally designated expert.
- Prescribed at the FDA-approved dose for ankylosing spondylitis.
- Vaccinations should be updated before initiation; recombinant zoster vaccine should be completed or initiated by end of first year of treatment.
Prior Therapy Requirements
- Tumor necrosis factor inhibitor (TNFI) therapy is medically inadvisable, not tolerated or not adequate (i.e., NO or partial response after 3 months or loss of initial response).
- Applies only to new starts; stable patients should not be switched to a criteria-required prior drug for nonmedical reasons.
Special Populations & Counseling
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception.
Document 818
Infection Screening & Management
- Completed tuberculosis (TB) 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.
- Antiviral prophylaxis for HBV must utilize agents with a high genetic barrier to resistance such as entecavir or tenofovir.
Contraindications & Exclusions
- Uncontrolled, active, severe infection, including undrained abscess (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 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.
Diagnosis & Treatment Requirements
- Definite or provisional diagnosis of active nonradiographic axial spondyloarthritis (nr-axSpA) made by a VA/VA Community Care rheumatologist.
- Prescribed at the FDA-approved dose for active nr-axSpA.
- Tumor necrosis factor inhibitor (TNFi) therapy is medically inadvisable, not tolerated, or not adequate (i.e., NO or partial response after 3 months or loss of initial response).
Specialist Oversight & Monitoring
- Prescribed and monitored by a VA/VA Community Care rheumatologist or locally designated expert.
Additional Patient-Specific Considerations
- If HBsAg-negative but anti-HBc-positive and practitioner deems consult 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.
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception.
General Prescribing Notes
- Criteria apply only to new starts; stable patients should not be switched to a criteria-required prior drug for nonmedical reasons.