VA Criteria for Use Formulary Advisor Reference
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SECUKINUMAB INJ,SOLN

Generic Name
SECUKINUMAB INJ
Brand Names
COSENTYX, COSENTYX (2 SYRINGES), COSENTYX SENSOREADY (2 PENS), COSENTYX SENSOREADY PEN, COSENTYX SYRINGE, COSENTYX UNOREADY PEN
Drug Class
IMMUNE SUPPRESSANTS
Formulary Status
Non-Formulary Requires prior authorization
Copay Tier
3
Last Updated
June 1, 2026

Clinical Criteria Summary

Document 202: Secukinumab COSENTYX in Plaque Psoriasis Criteria

Infection Screening & Management

  • Exclusion: Active infection (however, secukinumab may be started/restarted once treatment for the infection is initiated)
  • Exclusion: Untreated latent or active tuberculosis infection
  • Exclusion: Congenital or acquired immunodeficiency
  • Exclusion: Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients can be treated with secukinumab)

Vaccination Requirements

  • Inclusion: Offered all age-appropriate vaccinations prior to initiating therapy
  • Exclusion: Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation of secukinumab
  • Inclusion: If patient is at risk, completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]

Disease Characteristics & Monitoring

  • Inclusion: Chronic (≥ 6 months) moderate to severe plaque psoriasis (including involvement of nails only)
  • Inclusion: Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated psoriasis expert
  • Inclusion: Secukinumab is prescribed at the FDA-approved dose for plaque psoriasis

Prior Systemic Therapy Requirements

  • Inclusion (ONE of the following must be selected): Methotrexate monotherapy is medically inadvisable, not tolerated, not adequate, or lost response
  • Inclusion (ONE of the following must be selected): Tumor necrosis factor inhibitor (TNFi) is medically inadvisable, not tolerated, not adequate, or lost response
  • Inclusion (ONE of the following must be selected): Ustekinumab is medically inadvisable, not tolerated, not adequate, or lost response

Hepatitis Screening & Management

  • Inclusion: Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc] and antibody to hepatitis B surface antigen [anti-HBs])
  • Inclusion: Current or past completion of hepatitis C screening (Secukinumab may be initiated while waiting for test results)
  • Inclusion: If HBsAg-negative but anti-HBc-positive and consult is deemed indicated, a 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

Special Populations & Counseling

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

New Start Requirements

  • Inclusion: For new starts: Had intolerance or inadequate response to ixekizumab. Ixekizumab is the preferred interleukin-17A inhibitor in new starts.

Document 574: Secukinumab COSENTYX in Ankylosing Spondylitis Criteria

Exclusion Criteria

  • Uncontrolled active 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)
  • 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

Core Inclusion Criteria

  • Definite or provisional diagnosis of active ankylosing spondylitis (or radiographic axial spondyloarthritis)
  • Prescribed and monitored by a VA / VA Community Care rheumatologist or locally designated expert
  • FDA-approved dose for ankylosing spondylitis
  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • Completed hepatitis B screening (at minimum: HBsAg, total antibody-to-hepatitis-B-core-antigen [anti-HBc], and anti-HBs)
  • Current or past completion of hepatitis C screening (may initiate while waiting for results)
  • Tumor necrosis factor inhibitor (TNFi) is medically inadvisable, not tolerated, or not adequate (NO or partial response after 3 months or loss of initial response) [Applies only to new starts]

Additional Inclusion Criteria

  • If HBsAg-negative but anti-HBc-positive: Consultation with gastroenterologist/hepatologist or infectious diseases expert for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
  • For new starts: Intolerance or inadequate response to ixekizumab (preferred interleukin-17A inhibitor in new starts)
  • For patients who can become pregnant and partners who can become pregnant: Counseling provided on potential risks vs benefits and use of effective contraception

Clinical Management & Monitoring Notes

  • Antiviral prophylaxis for HBV should utilize agents with a high genetic barrier to resistance (entecavir or tenofovir)
  • Vaccinations should be updated before initiation when possible; recombinant zoster vaccine should be completed or initiated by the end of the first year, preferably at low dosage, stable disease, or when robust immune response is expected
  • Stable patients on secukinumab should not be switched to a criteria-required prior drug for nonmedical reasons

Document 575: Secukinumab COSENTYX in Nonradiographic Axial Spondyloarthritis Criteria

Diagnosis & Prescribing Requirements

  • Definite or provisional diagnosis of active nonradiographic axial spondyloarthritis (nr-axSpA) made by a VA/VA Community Care rheumatologist
  • Prescribed and monitored by a VA/VA Community Care rheumatologist or locally designated expert
  • Prescribed at the FDA-approved dose for active nr-axSpA

Infectious Disease Screening & Management

  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • Completed hepatitis B screening (at minimum, 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 HBsAg-negative but anti-HBc-positive and practitioner deems consult indicated: GI/liver or ID expert consulted for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation

Exclusion Criteria

  • Uncontrolled active 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)
  • 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

Prior Therapy Requirements

  • Tumor necrosis factor inhibitor (TNFi) is medically inadvisable, not tolerated, or not adequate (NO or partial response after 3 months or loss of initial response) [Applies only to new starts]
  • For new starts: Had intolerance or inadequate response to ixekizumab (Ixekizumab is the preferred interleukin-17A inhibitor in new starts)

Counseling & Special Populations

  • For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception

Document 576: Secukinumab COSENTYX in Psoriatic Arthritis Criteria

Exclusion Criteria

  • Active infection (secukinumab 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 can 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

  • Has inflammatory articular disease (joint, spine, and/or entheseal), and a definite or provisional diagnosis of psoriatic arthritis
  • Prescribed and monitored by a VA / VA Community Care rheumatologist, dermatologist or locally designated expert
  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • Completed hepatitis B screening (at minimum, 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)
  • 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)

Additional Inclusion Criteria

  • If HBsAg-negative but anti-HBc-positive: A gastroenterologist/hepatologist or infectious diseases expert has been consulted for advice on whether to start antiviral prophylaxis or to preemptively monitor for HBV reactivation
  • For new starts: Had intolerance or inadequate response to ixekizumab (ixekizumab is the preferred interleukin-17A inhibitor in new starts)
  • 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

Screening, Monitoring & Sequencing Guidelines

  • Routine rescreening is not required for prescription renewals; retesting in high-risk patients should be considered
  • 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
  • Applies to new starts only; stable patients on treatment should not be switched for nonmedical reasons
  • 1L: csIMM (for predominantly peripheral arthritis, no axial disease, no severe psoriasis, no IBD/uveitis) or TNFi
  • 2L: IL-17i (ixekizumab preferred; may prefer over TNFi if concomitant psoriasis is severe) or JAKi
  • 3L: IL-12/23i or IL-23i (not for axial disease; may prefer over IL-12/23i if concomitant psoriasis is severe)
  • 4L: Abatacept (not for axial disease)
  • Other: Apremilast, Deucravacitinib

Document 584: Secukinumab COSENTYX SC in Hidradenitis Suppurativa Criteria Mar 2024

Indication

  • Moderate to severe hidradenitis suppurativa (HS)

Provider Requirements

  • Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated expert

Screening & Testing Requirements

  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA]
  • Completed hepatitis B screening (at minimum, 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

Exclusion Criteria

  • Uncontrolled active infection, including furunculosis and carbuncles (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)
  • 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

Prior Therapy Requirements

  • Adalimumab / biosimilar (preferred) or infliximab / biosimilar (alternative) is medically inadvisable, not tolerated, or not adequate (i.e., NO treatment benefit after 3 months or inadequate partial response after 4 months)

Additional Inclusion Criteria

  • If HBsAg-negative but anti-HBc-positive: A 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 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

Adjudication & Monitoring Notes

  • Aversity to injections (adalimumab/biosimilar) or infusions/barriers to in-clinic administration (infliximab/biosimilar, e.g., travel) should be adjudicated case by case
  • Routine retesting for TB, hepatitis B, and hepatitis C is not required for prescription renewals; retesting in high-risk patients should be considered
  • For HBsAg-negative/anti-HBc-positive patients, anti-HBs titers do not guarantee protection against HBV reactivation; management depends on the patient’s risk of HBV reactivation

Document 592: MON Secukinumab COSENTYX SC in Hidradenitis Suppurativa Monograph Mar 2024

Indication & Patient Population

  • Treatment of adults with moderate to severe hidradenitis suppurativa (HS)
  • Adults ≥ 18 years of age
  • Moderate to severe HS defined as total of ≥ 5 inflammatory lesions affecting at least two distinct anatomical areas for at least 1 year

Dosage & Administration

  • 300 mg subcutaneous injection at Weeks 0, 1, 2, 3, and 4, then every 4 weeks thereafter
  • Dosage increase to 300 mg SC every 2 weeks may be considered if patient has an inadequate response
  • Available as 300 mg/2 mL in a single-dose UnoReady pen or single-dose prefilled syringe

Contraindications & Warnings/Precautions

  • Hypersensitivity
  • Infections
  • Hypersensitivity reactions
  • Tuberculosis (TB)
  • Inflammatory bowel disease
  • Eczematous eruptions
  • Risk of hypersensitivity in latex-sensitive individuals
  • Immunization: avoid live vaccines

VA Formulary Restrictions & Step Therapy Requirements

  • No CFU for other indications
  • FDA approved for HS in 2023
  • Potential Use in VHA: Treatment of moderate to severe HS after a trial of adalimumab / biosimilar (preferred) or infliximab / biosimilar (alternative)

Safety & Monitoring Considerations

  • Boxed Warnings: None
  • Top Adverse Events: Nasopharyngitis, diarrhea, upper respiratory tract infection
  • Drug Interactions: Certain CYP450 substrates, particularly those where minimal changes in concentration may affect efficacy or safety

Source Documents

Document 202: Secukinumab COSENTYX in Plaque Psoriasis Criteria Document 574: Secukinumab COSENTYX in Ankylosing Spondylitis Criteria Document 575: Secukinumab COSENTYX in Nonradiographic Axial Spondyloarthritis Criteria Document 576: Secukinumab COSENTYX in Psoriatic Arthritis Criteria Document 584: Secukinumab COSENTYX SC in Hidradenitis Suppurativa Criteria Mar 2024 Document 592: MON Secukinumab COSENTYX SC in Hidradenitis Suppurativa Monograph Mar 2024