VA Criteria for Use Formulary Advisor Reference
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DEUCRAVACITINIB TAB

Generic Name
DEUCRAVACITINIB TAB
Brand Names
SOTYKTU
Drug Class
ANTIPSORIATICS,SYSTEMIC
Formulary Status
Non-Formulary Requires prior authorization
Copay Tier
3
Last Updated
June 1, 2026

Clinical Criteria Summary

Document 430: MON Deucravacitinib SOTYKTU in Plaque Psoriasis Monograph Apr 2023

Indication & Patient Population

  • Treatment of moderate to severe plaque psoriasis (PsO) in adults who are candidates for systemic therapy or phototherapy.
  • Not recommended for use in combination with other potent immunosuppressants.

Pretreatment Evaluation & Screening

  • Tuberculosis (TB) screening required; initiate TB treatment prior to deucravacitinib if positive. Do not initiate in patients with latent or active TB infection.
  • Update immunizations.
  • Consider hepatitis B or C screening; not recommended for patients with active hepatitis B or C.
  • Consider baseline triglyceride levels.
  • Obtain baseline liver enzymes; not recommended for severe hepatic impairment (Child-Pugh C).
  • Consider baseline creatine phosphokinase (CPK) (US prescribing information does not recommend routine baseline CPK).

Monitoring During Therapy

  • Monitor triglyceride levels per clinical guidelines for hyperlipidemia.
  • Monitor liver enzymes in patients with known or suspected liver disease per routine patient management.
  • Consider checking CPK periodically or in patients with suspected/diagnosed myopathy; discontinue deucravacitinib if CPK becomes markedly elevated.

Dosing & Administration

  • Recommended dose: 6 mg orally once daily with or without food.
  • Do not crush, cut, or chew tablets.
  • Dosage form: Film-coated tablets, 6 mg in bottles of 30.

Special Populations & Dose Adjustments

  • Renal impairment: No dosage adjustments required.
  • Hepatic impairment: No adjustments for mild (Child-Pugh A) or moderate (Child-Pugh B). Not recommended for severe (Child-Pugh C) hepatic impairment.

Safety, Contraindications & Precautions

  • Contraindication: Hypersensitivity.
  • Warnings/Precautions: Infections, herpes viral reactivation, TB, malignancy including lymphomas, rhabdomyolysis and elevated CPK, triglyceride elevations, liver enzyme elevations, update immunizations (avoid live vaccines during treatment), potential JAK inhibitor-related adverse reactions.
  • Lacks boxed warnings for serious infections, mortality, major adverse cardiovascular events (MACE), malignancy excluding nonmelanoma skin cancer, and thrombosis (insufficient evidence to determine if TYK2 inhibition increases these risks).
  • No increased risk of serious/opportunistic infections, mortality, MACE, thrombosis, liver injury, or GI perforation reported.
  • No hematologic adverse events; monitoring for cytopenias is not required.

Place in Therapy & Comparative Considerations

  • Not restricted to patients with disease not adequately controlled by other systemic drugs including biologics or when those therapies are inadvisable.
  • Superior to apremilast for scalp psoriasis; numerically better for fingernail psoriasis.
  • Requires monitoring of triglycerides, liver enzymes, and CPK (unlike apremilast, which requires no lab monitoring except potential age-related renal function checks).
  • Offers oral administration convenience similar to other small molecules.

Document 434: Deucravacitinib SOTYKTU in Plaque Psoriasis Criteria

Exclusion Criteria

  • Active infection (may initiate/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 (consider hepatitis B virus screening; safety unknown in patients with current or past HBV infection)
  • Untreated active hepatitis C (consider hepatitis C virus screening; safety unknown in patients with current or past hepatitis C infection)
  • Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated; safety unknown in patients with HIV seropositivity)
  • Malignancy within the previous 5 years other than successfully treated nonmelanoma skin cancer or successfully treated cervical cancer (unless treating dermatologist and oncologist agree risk-benefits favor use)
  • Severe hepatic impairment (Child-Pugh C)
  • Concomitant therapy with other potent immunosuppressants
  • Concomitant live or live-attenuated vaccines or administration of non-live or live vaccines less than 2 weeks before initiation

Inclusion Criteria

  • Diagnosis of moderate to severe plaque psoriasis
  • Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated psoriasis expert
  • Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
  • Completed liver enzyme tests
  • Methotrexate monotherapy is medically inadvisable, not tolerated, or inadequate (NO treatment benefit after 3 months, of which at least 2 months is at the standard target dose of 15–25 mg ONCE WEEKLY PO/SC/IM, or inadequate response after 6 months)
  • Three targeted systemic antipsoriatic drugs (≥ 1 drug per class) are medically inadvisable, not tolerated, or not adequate: Inhibitors of TNF, IL-17 (ixekizumab preferred), IL-23 (e.g., risankizumab), IL-12/23 (ustekinumab) or PDE-4 (apremilast)

Additional Inclusion Criteria & Special Populations

  • If HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive: Consultation with a GI/liver or infectious diseases expert for advice on starting antiviral prophylaxis or preemptively monitoring for HBV reactivation
  • For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception

Monitoring, Sequencing & Administration Requirements

  • Routine rescreening is not required for prescription renewals; retesting in high-risk patients should be considered
  • Applies to new starts only; stable patients (responded to induction and/or controlled on maintenance therapy) should not be switched for nonmedical reasons
  • Systemic therapy sequencing: 1L Methotrexate or TNFi or ustekinumab (± phototherapy); 2L Interleukin-17A inhibitor (ixekizumab preferred over secukinumab); 3L Interleukin-23 inhibitor; 4L Bimekizumab; Other: Apremilast, deucravacitinib, brodalumab
  • An interleukin-17A inhibitor (ixekizumab preferred) may be used as 1L if psoriasis is severe
  • Vaccinations should be updated before initiation when possible; recombinant zoster vaccine should be completed or initiated by the end of the first year of treatment, preferably at low dosage, stable disease, or times expecting a robust immune response

Document 874: Deucravacitinib SOTYKTU in Psoriatic Arthritis Criteria Jun 2026

Infection Screening & Management

  • Active or serious 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 (consider hepatitis B virus screening; safety unknown in patients with current or past HBV infection)
  • Untreated active hepatitis C (consider hepatitis C virus screening; safety unknown in patients with current or past hepatitis C infection)
  • Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients can be treated; safety of this drug is unknown in patients with HIV seropositivity)
  • 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 hepatitis B surface antibody [anti-HBs]) or documentation that screening was considered and deemed unnecessary
  • Routine retesting is not required for prescription renewals; consider retesting in patients at risk

Malignancy History

  • Malignancy within the previous 5 years other than successfully treated nonmelanoma skin cancer or successfully treated cervical cancer (unless treating rheumatologist/dermatologist and oncologist agree that risk-benefits favor using the drug)

Hepatic, Metabolic, & Musculoskeletal Status

  • Severe hepatic impairment (Child-Pugh C)
  • Markedly elevated creatine phosphokinase or suspected current or recent history (within 12 months) of rhabdomyolysis
  • Untreated hypertriglyceridemia
  • Completed liver enzyme tests

Vaccination Requirements

  • Concomitant live or live-attenuated vaccines or administration of non-live or live vaccines less than 2 weeks before initiation
  • Offered all age-appropriate vaccinations prior to initiating therapy, including prophylactic herpes zoster vaccination
  • Unless contraindicated, 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 to vaccination can be expected

Specialist Oversight & Diagnosis

  • Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist, or locally designated expert
  • Has inflammatory articular disease (joint, spine, and/or entheseal) and a definite or provisional diagnosis of psoriatic arthritis
  • History of or active plaque psoriasis

Prior Therapy Requirements

  • A conventional synthetic immunomodulator (csIMM; e.g., methotrexate) or TNF inhibitor is medically inadvisable, not tolerated, or inadequate
  • An IL-17 inhibitor or JAK inhibitor is medically inadvisable, not tolerated, or inadequate
  • An IL-12/23 inhibitor or IL-23 inhibitor is medically inadvisable, not tolerated, or inadequate
  • Apremilast is medically inadvisable, not tolerated, or inadequate
  • Applies to new starts only; patients on treatment who are stable should not be switched to a criteria-required prior treatment for nonmedical reasons

Special Populations & Consultations

  • For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy
  • For females who are lactating/providing breastmilk to an infant or planning to do so: Counseling provided on potential risks vs benefits of treatment
  • If HBsAg-negative but total anti-HBc-positive and patient’s practitioner deems consult indicated, a GI/liver or ID expert has been consulted for advice on whether to start antiviral prophylaxis or to preemptively monitor for HBV reactivation

Treatment Sequencing

  • 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 (not for axial disease) 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 875: MON Deucravacitinib SOTYKTU in Psoriatic Arthritis Monograph Jun 2026

Indication & Patient Population

  • Active psoriatic arthritis (PsA) in adults
  • Adults with active PsA (≥ 3 swollen joint count [SJC], ≥ 3 tender joint count [TJC], CRP ≥ 3 mg/L) and active or history of plaque psoriasis
  • Diagnosis of PsA for ≥ 3 months
  • Patients with inadequate response, intolerance, or loss of response to NSAIDs, conventional synthetic immunomodulators (csIMMs), or apremilast

Dosing & Administration

  • 6 mg PO QD with or without food
  • No recommended dose modifications for adverse events
  • Not recommended in patients with severe hepatic impairment (Child-Pugh C)
  • Not recommended with other potent immunosuppressants

Contraindications & Warnings/Precautions

  • History of hypersensitivity reaction to deucravacitinib or product excipients
  • Active or serious infection: Avoid use
  • Tuberculosis (TB): Evaluate for latent or active TB before initiating therapy
  • Viral reactivation: Consider viral hepatitis screening; not recommended in patients with active hepatitis B or C
  • Malignancies: Consider risk-benefit before initiating or continuing therapy
  • Rhabdomyolysis and elevated CPK: Discontinue if significant elevation in CPK levels or diagnosis/suspicion of myopathy
  • Triglyceride elevations: Periodically evaluate serum triglycerides
  • Liver enzyme elevations: Evaluate at baseline and during therapy in patients with known or suspected liver disease
  • Immunizations: Avoid use with live vaccines; complete age-appropriate immunizations before initiating (including prophylactic herpes zoster vaccination)
  • Potential risks related to JAK inhibition: Unknown if TYK2 inhibition is associated with observed/potential adverse reactions of JAK inhibition (increased rates of mortality, malignancy other than nonmelanoma skin cancer, major adverse cardiovascular events, and thrombosis in patients ≥ 50 years with rheumatoid arthritis who had ≥ 1 cardiovascular risk factor)

Monitoring Requirements

  • LFTs, CPK, and triglycerides at baseline; repeat at 4–8 weeks, then every 12 weeks
  • Consider CPK monitoring (not labeled but potential JAKi-class effect)
  • Screen for TB before initiation
  • Monitor for >5% weight loss

Treatment Sequencing & Place in Therapy

  • FDA-approved without a line-of-therapy restriction
  • Evidence suggests use after csIMM or TNFi, IL-17i or JAKi, IL-12/23i or IL-23i, and apremilast for inadequate response/intolerance
  • May be considered for patients with active, nonsevere peripheral PsA and significant psoriasis who prefer oral therapy over injectable biologics
  • Consider for patients at higher risk of JAKi-class adverse effects (serious infection, MACE, thromboembolism), though comparative safety advantage has not been established in head-to-head trials

Domain-Specific Efficacy Considerations

  • Peripheral arthritis: Effective; significant improvement in ACR20 response
  • Enthesitis: Inconsistent resolution; 6-mg dose showed significantly better effects than placebo, 12-mg dose did not
  • Dactylitis: Meta-analysis showed ineffective for resolution; phase 2 trial showed inconsistent resolution
  • Axial disease: No data on efficacy; not established
  • Uveitis: Not established/insufficient evidence

Safety & Comorbidity Profile

  • Associated with elevated CPK, mouth ulcers, acne, and folliculitis
  • Not associated with cytopenias in short-term studies
  • No specific warning for depression risk
  • Weight-neutral
  • Generally well-tolerated GI profile

Source Documents

Document 430: MON Deucravacitinib SOTYKTU in Plaque Psoriasis Monograph Apr 2023 Document 434: Deucravacitinib SOTYKTU in Plaque Psoriasis Criteria Document 874: Deucravacitinib SOTYKTU in Psoriatic Arthritis Criteria Jun 2026 Document 875: MON Deucravacitinib SOTYKTU in Psoriatic Arthritis Monograph Jun 2026