SECUKINUMAB INJ,SOLN
Clinical Criteria Summary
Document 202
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
Inclusion Criteria
- Chronic (≥ 6 months) moderate to severe plaque psoriasis (including involvement of nails only)
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated psoriasis expert
- Secukinumab prescribed at the FDA-approved dose for plaque psoriasis
- 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)
Additional Inclusion Criteria
- If HBsAg-negative but anti-HBc-positive: Consultation with a gastroenterologist/hepatologist or infectious diseases expert regarding antiviral prophylaxis or preemptive monitoring for HBV reactivation
- For new starts: 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 on potential risks vs benefits of treatment and use of effective contraception
Screening, Monitoring, & Clinical Definitions
- Tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay [IGRA] must be completed; routine retesting not required for renewals, but should be considered in high-risk patients
- Hepatitis B screening (at minimum, HBsAg, total anti-HBc, and anti-HBs) must be completed; routine retesting not required for renewals, but should be considered in high-risk patients
- Hepatitis C screening must be current or past completed; may initiate while waiting for results; routine retesting not required for renewals, but should be considered in high-risk patients
- Methotrexate monotherapy is considered "not adequate" if there is NO treatment benefit after 3 months (with at least 2 months at standard target dose) or inadequate partial response after 6 months; target doses are 15–25 mg ONCE WEEKLY orally, subcutaneously, or intramuscularly
- Phototherapy is medically inadvisable for reasons including confirmed history of skin cancer, melanoma, or strong likelihood of developing them (e.g., Fitzpatrick skin type I or II)
- TNFi is medically inadvisable for reasons including heart failure, demyelinating disease, multiple sclerosis in first-degree relative, lupus, recurrent infections, or serious infections
- In HBsAg-negative but anti-HBc-positive patients, presence of anti-HBs does not guarantee protection against HBV reactivation; management depends on patient’s risk of HBV reactivation
Document 592
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
Document 574
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
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
Diagnosis & Disease Activity
- Definite or provisional diagnosis of psoriatic arthritis
- Inflammatory articular disease (joint, spine, and/or entheseal)
Prior Therapy & Treatment History
- 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)
- For new starts: Had intolerance or inadequate response to ixekizumab (ixekizumab is the preferred interleukin-17A inhibitor in new starts)
Infectious Disease Screening & Management
- Exclusion: Uncontrolled active infection, including undrained abscess (may start/restart once the infection is controlled)
- Exclusion: Untreated latent or active tuberculosis infection
- Exclusion: Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
- Exclusion: Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
- Inclusion: Completed hepatitis C screening (current or past completion; may initiate while waiting for test results)
- Additional: If HBsAg-negative but anti-HBc-positive, consultation with a gastroenterologist/hepatologist or infectious diseases expert is required to advise on starting antiviral prophylaxis versus preemptively monitoring for HBV reactivation
Vaccination Requirements
- Exclusion: Concomitant live or live-attenuated vaccines, or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
- Supplemental: 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
Pregnancy & Reproductive Counseling
- For patients who can become pregnant and partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
Prescribing, Monitoring & Re-testing Guidelines
- Prescribed and monitored by a VA / VA Community Care rheumatologist, dermatologist or locally designated expert
- Routine retesting for tuberculosis (TB), hepatitis B, and hepatitis C is not required for prescription renewals; retesting in high-risk patients should be considered
- Exceptions to exclusion/inclusion criteria should be adjudicated at the local facility according to P&T committee and pharmacy services policy/procedures
Document 584
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