IXEKIZUMAB INJ,SOLN
Clinical Criteria Summary
Document 208: Ixekizumab TALTZ in Ankylosing Spondylitis Criteria
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: Ixekizumab TALTZ in Nonradiographic Axial Spondyloarthritis Criteria
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.
Document 828: Ixekizumab TALTZ in Psoriasis Criteria
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 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
Core Inclusion Criteria (All Required)
- 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)
Additional Inclusion Criteria (One Required)
- 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
Conditional/Additional Inclusion Criteria (Select if Applicable)
- 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
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
- For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits of treatment
Clinical Definitions & Sequencing Context
- Inadequate response to methotrexate: NO treatment benefit after 3 months (at least 2 months at standard target dose) or inadequate partial response after 6 months. Target doses: 15–25 mg once weekly orally, subcutaneously, or intramuscularly.
- TNFI therapy considered inadequate: NO or partial response after 3 months or loss of initial response.
- Ustekinumab therapy considered inadequate: NO response after 16 weeks, inadequate partial response after 32 weeks, or loss of initial response.
- Risk factors for latent TB reactivation include additional immunosuppressants (e.g., systemic corticosteroids, methotrexate), living in or traveling to regions with high TB prevalence, exposure, etc.
- Sequencing: 1L includes methotrexate, TNFi, or ustekinumab (± phototherapy). 2L is interleukin-17A inhibitor (ixekizumab preferred over secukinumab). An IL-17A inhibitor may be used 1L if psoriasis is severe.
- Routine rescreening is not required for prescription renewals; retesting in high-risk patients should be considered.
Document 879: Ixekizumab TALTZ in Psoriatic Arthritis Criteria
Infection Screening & Management
- Active infection (ixekizumab 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 (ixekizumab may be initiated after starting antiviral prophylaxis)
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients can be treated)
- Congenital or acquired immunodeficiency
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
- Completed hepatitis B screening (HBsAg, total hepatitis B core antibody [anti-HBc] and antibody to hepatitis B surface antigen [anti-HBs])
- Current or past completion of hepatitis C screening (ixekizumab may be initiated while waiting for test results)
Immunization Requirements
- Offered all age-appropriate vaccinations prior to initiating therapy
- Concomitant live or live-attenuated vaccines, or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation (exclusion criterion)
Specialist Oversight & Diagnosis
- Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist or locally designated expert
- Inflammatory articular disease (joint, spine, and/or entheseal), and a definite or provisional diagnosis of psoriatic arthritis
Prior Therapy Requirements
- Tumor necrosis factor inhibitor (TNFI) therapy is medically inadvisable, not tolerated or not adequate (i.e., NO or partial response after 12 weeks or loss of initial response)
Special Populations & Consultations
- HBsAg-negative but anti-HBc-positive patients where consult is deemed indicated: GI/liver or infectious diseases expert has been (e-)consulted for advice on whether to start antiviral prophylaxis or to preemptively monitor for HBV reactivation
- Females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception