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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 and Psoriatic Arthritis Criteria

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 (may initiate after starting prophylaxis)
  • HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive and not on antiviral prophylaxis (may initiate after starting 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 for Plaque Psoriasis

  • 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 initiate while waiting for 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) is medically inadvisable, not tolerated or not adequate (i.e., NO or partial response after 3 months or loss of initial response)

Inclusion Criteria for Psoriatic Arthritis

  • Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist or locally designated expert
  • Prescribed at the FDA-approved dose for psoriatic arthritis or at the FDA-approved dose for plaque psoriasis when treating both conditions
  • Has inflammatory articular disease (joint, spine, and/or entheseal), and a definite or provisional diagnosis of psoriatic arthritis
  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • Completed hepatitis B screening (at minimum, HBsAg, anti-HBc and anti-HBs)
  • Completed hepatitis C screening
  • 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
  • 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)

Source Documents