VA Criteria for Use Formulary Advisor Reference
← Back to Drug List

RISANKIZUMAB-RZAA INJ,SOLN NEW

Generic Name
RISANKIZUMAB-RZAA INJ
Brand Names
SKYRIZI, SKYRIZI ON-BODY, SKYRIZI PEN
Drug Class
ANTIRHEUMATICS,OTHER
Formulary Status
Non-Formulary Requires prior authorization
Copay Tier
3
Last Updated
August 1, 2026

Clinical Criteria Summary

Document 422: Risankizumab SKYRIZI in Crohns Disease Criteria

Indication & Diagnosis

  • Current or prior moderate to severe Crohn’s disease confirmed by endoscopy or imaging
  • Prescribed and monitored by a VA/VA Community Care gastroenterologist or locally designated expert
  • Exclusion Criteria (Patient will NOT meet criteria if ANY are present)
  • Active infection (may be started/restarted once treatment for the infection has been 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
  • Liver cirrhosis unless prescriber documents that potential benefits outweigh risks

Pre-treatment Screening & Monitoring

  • Offered all age-appropriate vaccinations prior to initiating therapy
  • 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
  • Obtained pretreatment liver enzymes and bilirubin levels
  • Prior Therapy & Sequencing Requirements (ALL must be met, plus ONE additional)
  • Ustekinumab is medically inadvisable, not tolerated, or not adequate, or lost response
  • Tumor necrosis factor inhibitor (TNFI) is medically inadvisable
  • Primary nonresponse, inadequate partial response, or loss of response after 12 weeks of one TNFI in the presence of adequate TNFI levels (mechanistic failure)
  • Loss of response to a TNFI despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure
  • Typically sequenced as a third-line (3L) therapy following TNFI or ustekinumab
  • May be used as first-line (1L) for “moderate” Crohn’s disease, absence of extraintestinal manifestations, or pouchitis per criteria
  • Certain severe cases may require faster escalation to 3L therapies after initial TNFI failure to prevent complications and surgeries (determined in collaboration between pharmacy and IBD prescriber)

Special Populations & Counseling

  • Females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception during therapy and for 5 months after stopping treatment
  • Females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits of treatment

Renewal & Maintenance Considerations

  • Routine retesting is not required for prescription renewals; retesting in high-risk patients should be considered
  • Applies only to new starts; stable patients who responded to induction and/or are controlled on maintenance therapy should not be switched to a criteria-required prior drug for nonmedical reasons
  • Antiviral prophylaxis for HBV requires agents with a high genetic barrier to resistance (e.g., entecavir or tenofovir)
  • 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 can be expected

Document 346: Risankizumab rzaa SKYRIZI in Psoriatic Arthritis Criteria

Exclusion Criteria

  • Active infection (may initiate/restart once treatment for the infection has been 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

  • Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist, or locally designated psoriasis expert
  • Inflammatory articular disease (joint, spine, and/or entheseal) with a definite or provisional diagnosis of psoriatic arthritis
  • ONE tumor necrosis factor inhibitor (TNFi) is medically inadvisable, not tolerated, or not adequate (i.e., NO or partial response after 12 weeks or lost response)
  • ONE interleukin-17A inhibitor (IL-17AI; i.e., ixekizumab [preferred] or secukinumab) or JAK inhibitor is medically inadvisable, not tolerated or not adequate

Additional Inclusion Criteria

  • If HBsAg-negative but anti-HBc-positive and consult deemed indicated: GI/liver or infectious diseases expert has been consulted for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
  • For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception
  • For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits of treatment

Screening, Vaccination & Monitoring Requirements

  • Offered all age-appropriate vaccinations prior to initiating therapy
  • 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 (may initiate while waiting for test results)
  • Routine rescreening is not required for prescription renewals; retesting in high-risk patients should be considered
  • 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 times when a robust immune response can be expected

Treatment Sequencing & Prior Therapy Requirements

  • Applies to new starts only; patients on treatment who are stable 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 (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 210: Risankizumab SKYRIZI in Plaque Psoriasis Criteria

Exclusion Criteria

  • Active infection (risankizumab-rzaa 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)
  • 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

  • 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)
  • Interleukin-17A inhibitor (i.e., ixekizumab [preferred] or secukinumab) is medically inadvisable, not tolerated, not adequate (i.e., NO response after 12 weeks, inadequate partial response after 24 weeks), or lost response

Prior Therapy & Sequencing Requirements

  • ONE of the following must be met: Methotrexate monotherapy, Tumor necrosis factor inhibitor (TNFI), or Ustekinumab is medically inadvisable, not tolerated, not adequate, or lost response
  • Patients on targeted immunomodulators are NOT required to backstep to methotrexate
  • Inadequate response definitions: Methotrexate (NO treatment benefit after 3 months, of which at least 2 months is at the standard target dose; or inadequate partial response after 6 months); TNFI (NO or partial response after 3 months or loss of initial response); Ustekinumab (NO response after 16 weeks, inadequate partial response after 32 weeks, or loss of initial response)
  • Systemic therapy sequencing: First-line (1L) includes methotrexate, TNFi, or ustekinumab; Second-line (2L) includes interleukin-17A inhibitors; Third-line (3L) includes interleukin-23 inhibitors (e.g., risankizumab); Other options include apremilast, deucravacitinib, brodalumab
  • Prior therapy requirements apply to new starts only; stable patients should not be switched for nonmedical reasons

Screening & Monitoring Requirements

  • 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 is deemed indicated, 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
  • Routine rescreening is not required for prescription renewals; retesting in high-risk patients should be considered

Special Population Counseling Requirements

  • 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

Document 360: MON Risankizumab rzaa SKYRIZI in Psoriatic Arthritis Monograph Addendum Aug 2022

Indication & Patient Population

  • • Treatment of active psoriatic arthritis (PsA) in adults
  • • Active PsA defined as symptom onset ≥ 6 months, meeting classification criteria for PsA, TJC ≥ 5 of 68, SJC ≥ 5 of 66, ≥ 1 erosion in hands and/or feet or hsCRP ≥ 3.0 mg/L, and active PsO (≥ 1 plaque ≥ 2 cm diameter or nail psoriasis)

Prior Therapy Requirements & Place in Therapy

  • • FDA-approved indication does not require trials of any prior therapies
  • • May be used as an alternative to (at the same level as) ustekinumab and guselkumab for patients with active nonaxial, nonerosive PsA who have had an inadequate response to at least one TNFI and at least one IL-17AI, unless medically inadvisable
  • • Ixekizumab is preferred in new starts within the IL-17AI class
  • • Supported for patients with active PsA who have had an inadequate response to conventional immunomodulators and/or biologics, or for whom these therapies are medically inadvisable

Efficacy Considerations & Disease Features

  • • Effective for: achievement of ACR20 response, minimal disease activity (MDA), improvement in joint/entheseal/dactylitis/nail manifestations, function, and quality of life
  • • IL-23 inhibitors may be preferred over ustekinumab for severe PsA-associated plaque psoriasis
  • • Ineffective or low certainty for: short-term (24-week) improvement in dactylitis, preventing radiographic progression of peripheral erosive disease, and symptomatic MRI-verified axial PsA

Safety Considerations

  • • Safety considerations include infections and TB
  • • Safety profile generally consistent with that in plaque psoriasis

Dosing & Administration

  • • 150 mg subcutaneously at Weeks 0 and 4, then every 12 weeks
  • • May be administered alone or in combination with nonbiologic immunomodulators

Document 423: MON Risankizumab rzaa SKYRIZI in Crohns Disease Monograph Mar 2023

Indication

  • Treatment of moderately to severely active Crohn’s disease (CD) in adults.

Patient Selection & Place in Therapy

  • May be less preferred than TNFIs (infliximab-abda or adalimumab) as first-line treatment to induce clinical remission in patients with moderate to severe, active luminal CD who have an inadequate response to conventional therapies.
  • May be preferred over vedolizumab for second-line induction therapy in biologic-exposed patients.
  • May be effective for skin and joint comorbidities of CD based on FDA approvals for plaque psoriasis and psoriatic arthritis.

Dosing & Administration

  • Induction: 600 mg IV infusion over at least 1 hour at Weeks 0, 4, and 8.
  • Maintenance: 180 mg or 360 mg SC at Week 12 then every 8 weeks thereafter; use the lowest effective dosage to maintain therapeutic response.
  • On-Body Injector (wearable injector) adheres to the skin and administers each dose over up to 5 minutes; must be kept at least 12 inches away from electronic devices during administration and should not be exposed to magnetic resonance imaging.
  • Duration of an adequate therapeutic trial is 12 weeks; onset of effects occurs at 4 weeks.

Monitoring & Pre-treatment Requirements

  • Before initiating treatment: obtain liver enzymes and bilirubin levels, evaluate for tuberculosis (TB) infection, and complete all guideline-recommended vaccinations.
  • Monitor liver enzymes and bilirubin during induction for up to at least 12 weeks of therapy, then per routine patient management.

Safety, Contraindications & Warnings

  • Contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any excipients.
  • Hepatotoxicity: Drug-induced liver injury has occurred during induction therapy; consider other treatment alternatives in patients with evidence of liver cirrhosis.
  • Warnings/Precautions include hypersensitivity reactions, infections (including TB), and avoiding use of live vaccines.

Limitations & Evidence Gaps

  • Efficacy and safety not reported in patients with fistulizing CD; not evaluated in patients with stricturing CD.
  • Comparative efficacy and safety of combination therapy with conventional immunomodulators relative to risankizumab-rzaa monotherapy is unknown.
  • On-Body Injector may not be suitable for patients who are blind without sighted assistance or have impaired dexterity.

Document 717: Risankizumab SKYRIZI in Ulcerative Colitis Criteria

Exclusion Criteria

  • Active infection (risankizumab-rzaa may be started/restarted once treatment for the infection has been 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
  • Liver cirrhosis unless the prescriber deems that the potential benefits outweigh the risks

Inclusion Criteria (All Must Be Met)

  • Prescribed and monitored by a VA/VA Community Care gastroenterologist or locally designated expert
  • Current or prior moderate to severe ulcerative colitis (UC) confirmed by endoscopy or imaging
  • Offered all age-appropriate vaccinations prior to initiating therapy
  • 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 (may initiate while waiting for test results)
  • Obtained liver panel including bilirubin
  • Ustekinumab is medically inadvisable, not tolerated, or not adequate, or lost response

Additional Inclusion Criteria (One Must Be Met)

  • Tumor necrosis factor inhibitor (TNFi) is medically inadvisable (Infliximab is the preferred TNFi in UC)
  • Primary nonresponse, inadequate partial response, or loss of response after 12 weeks of one TNFI in the presence of adequate TNFI levels (mechanistic failure)
  • Loss of response to a TNFI (infliximab is the preferred TNFi in UC) despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure

Sequencing & Line of Therapy

  • 1L: Infliximab (preferred), adalimumab, or ustekinumab. Vedolizumab may be used 1L for “moderate” UC, absence of extraintestinal manifestations, or pouchitis.
  • 2L: TNFi (if not previously used) or ustekinumab (if not previously used).
  • 3L: Vedolizumab, tofacitinib or upadacitinib after TNFi (or alternative systemic therapy if TNFi is medically inadvisable), guselkumab, risankizumab, etrasimod, or ozanimod.
  • 4L: Mirikizumab.
  • Severe UC may require earlier escalation to 3L therapies after initial TNFI failure to reduce risk of disease-related complications or colectomy.

Monitoring & Preventive Care Requirements

  • Routine retesting for TB and hepatitis screening is not required for prescription renewals; retesting in high-risk patients should be considered.
  • 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 when a robust immune response can be expected.

Special Populations & Consultations

  • If HBsAg-negative but anti-HBc-positive and consult is deemed indicated: 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 females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception.

Document 718: MON Risankizumab rzaa SKYRIZI in Ulcerative Colitis Monograph Feb 2025

Indication

  • Treatment of moderately to severely active ulcerative colitis (UC)

Patient Population & Clinical Criteria

  • Patients with inadequate response (IR) or intolerance (INT) to oral aminosalicylates, glucocorticoids (GCs), conventional immunomodulators (cIMMs) alone; ≥ 1 biologic, Janus kinase inhibitor (JAKi), and/or sphingosine-1-phosphate receptor modulator (S1PRM); or combination of conventional and advanced therapies
  • No prior exposure to ustekinumab (p40) or IL-23 (p19) inhibitors
  • Disease severity: modified Mayo score (mMS) of 5–9 and endoscopy subscore (ES) of 2–3

VHA PBM Guidance & Place in Therapy

  • No prerequisite therapy specified for UC
  • May be used for patients with medical inadvisability to, or mechanistic failure of, a TNFi, or pharmacokinetic failure of infliximab/biosimilar (the preferred TNFi in UC)
  • Evidence supports efficacy in inducing and maintaining clinical remission and endoscopic remission; place in therapy remains uncertain due to lack of head-to-head trials

Pretreatment & Monitoring Requirements

  • Obtain liver enzymes and bilirubin levels prior to treatment
  • Evaluate for tuberculosis (TB) infection prior to treatment
  • Administer guideline-recommended vaccinations prior to treatment
  • Monitor liver enzymes and bilirubin levels during induction (up to ≥ 12 weeks)
  • Monitor liver enzymes and bilirubin levels during subsequent treatment per routine patient management

Dosage Regimen

  • Induction: 1200 mg IV infusion over at least 2 hours at Weeks 0, 4, and 8
  • Maintenance: 180 mg or 360 mg SC at Week 12 then every 8 weeks thereafter; use the lowest effective dosage needed to maintain therapeutic response

Safety Considerations & Contraindications

  • Contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or excipients
  • Warnings include hypersensitivity reactions, infections, TB, hepatotoxicity during induction, and avoidance of live vaccines
  • Most common adverse events (≥3%): Arthralgia (induction); arthralgia, pyrexia, injection site reactions, rash (maintenance)
  • Geriatric use: Limited data available; 103 UC patients were aged ≥ 65 years in clinical trials
  • Drug interactions: No clinically significant changes observed for CYP450 substrates (caffeine, warfarin, omeprazole, metoprolol, midazolam)

Source Documents

Document 422: Risankizumab SKYRIZI in Crohns Disease Criteria Document 346: Risankizumab rzaa SKYRIZI in Psoriatic Arthritis Criteria Document 210: Risankizumab SKYRIZI in Plaque Psoriasis Criteria Document 360: MON Risankizumab rzaa SKYRIZI in Psoriatic Arthritis Monograph Addendum Aug 2022 Document 423: MON Risankizumab rzaa SKYRIZI in Crohns Disease Monograph Mar 2023 Document 717: Risankizumab SKYRIZI in Ulcerative Colitis Criteria Document 718: MON Risankizumab rzaa SKYRIZI in Ulcerative Colitis Monograph Feb 2025