VEDOLIZUMAB INJ,LYPHL
Clinical Criteria Summary
Document 189: Vedolizumab ENTYVIO IV in Inflammatory Bowel Disease Criteria
Exclusion Criteria
- Untreated latent or active tuberculosis infection
- Uncontrolled, active, severe infection (may start/restart once treatment for the infection is initiated)
- 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
- Concomitant treatment with drugs that have a contraindicated drug interaction (e.g., Bacillus Calmette-Guerin [BCG] vaccine) unless risk-benefits favor use
- Primary nonresponse to natalizumab
Mandatory Inclusion Criteria
- Prescribed and monitored by a VA/VA Community Care gastroenterologist or locally designated expert
- 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)
Additional Clinical Indications & Scenarios
- Current or prior overall physician assessment of “moderate to severe” CD or UC confirmed by endoscopy or imaging, and TNFI is medically inadvisable
- Current or prior overall physician assessment of “moderate to severe” CD or UC, and primary nonresponse, inadequate partial response, or loss of response after 12 weeks of one TNFI in the presence of adequate TNFI levels (mechanistic failure)
- Current or prior overall physician assessment of “moderate to severe” CD and loss of response to infliximab/biosimilar and another TNFI despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure
- Current or prior overall physician assessment of “moderate to severe” UC and loss of response to a TNFI (infliximab/biosimilar preferred) despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure
- No prior TNFI was deemed required because of documented current or prior overall physician assessment of “moderate” CD or UC disease or documented absence of extraintestinal manifestations
- Underwent IPAA and has documented chronic antibiotic-refractory or -dependent CD or UC pouchitis with intolerance, loss of response, or medical inadvisability to long-term antibiotic therapy (no prior TNFI required)
- Maintenance of clinical response or remission achieved with cyclosporine rescue therapy when immunomodulator maintenance is medically inadvisable (used for acute, severe UC)
- Prevention of recurrence after surgery for CD if TNFI therapy is medically inadvisable
Patient-Specific Considerations
- 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 females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
Document 723: Vedolizumab ENTYVIO in Inflammatory Bowel Disease Criteria
Criteria for Vedolizumab (VEDOLIZUMAB INJ,LYPHL and VEDOLIZUMAB INJ,SOLN)
- Note: The provided document outlines unified criteria for vedolizumab in IBD; all criteria below apply to both VEDOLIZUMAB INJ,LYPHL and VEDOLIZUMAB INJ,SOLN.
Exclusion Criteria
- Untreated latent or active tuberculosis infection
- Uncontrolled, active, severe infection (may be started/restarted once treatment for the infection is initiated)
- 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)
- 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
- Concomitant treatment with drugs that have a contraindicated drug interaction (e.g., Bacillus Calmette-Guerin [BCG] vaccine) unless risk-benefits favor use
- Primary nonresponse to natalizumab
General Inclusion Criteria
- Prescribed and monitored by a VA/VA Community Care gastroenterologist or locally designated expert
- 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 be initiated while waiting for test results)
Disease Severity & Treatment History Requirements
- One of the following must be selected:
- Current or prior overall physician assessment of “moderate to severe” CD or UC confirmed by endoscopy or imaging, and TNFI is medically inadvisable
- Current or prior overall physician assessment of “moderate to severe” CD or UC, and primary nonresponse, inadequate partial response, or loss of response after 12 weeks of one TNFI in the presence of adequate TNFI levels (mechanistic failure)
- Current or prior overall physician assessment of “moderate to severe” CD and loss of response to infliximab/biosimilar and another TNFI despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure
- Current or prior overall physician assessment of “moderate to severe” UC and loss of response to a TNFI (infliximab/biosimilar preferred) despite TDM-based optimized dosing to address pharmacokinetic failure
- No prior TNFI was deemed required because of documented current or prior overall physician assessment of “moderate” CD or UC disease or documented absence of extraintestinal manifestations
- Underwent IPAA and has documented chronic antibiotic-refractory or -dependent CD or UC pouchitis with intolerance, loss of response, or medical inadvisability to long-term antibiotic therapy (no prior TNFI required)
- Maintenance of clinical response or remission achieved with cyclosporine rescue therapy when immunomodulator maintenance is medically inadvisable (used for acute, severe UC)
- Prevention of recurrence after surgery for CD if TNFI therapy is medically inadvisable
Special Populations & Screening Requirements
- If HBsAg-negative but anti-HBc-positive: GI/liver or infectious diseases expert 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
Administration & Sequencing Guidelines
- Switching from IV to SC administration: SC administration may be started when clinical response is achieved after Week 6 following IV induction doses at Weeks 0 and 2, or when receiving IV doses to maintain clinical remission
- Clinical response definitions: VISIBLE 1 UC trial (reduction in total Mayo score ≥3 points and ≥30% from baseline with rectal bleeding subscore decrease ≥1 point or absolute ≤1); VISIBLE 2 CD trial (≥70-point decrease in CDAI score from baseline)
- Sequencing for CD: 1L Infliximab/biosimilar or adalimumab/biosimilar; Vedolizumab may be used 1L for “moderate” CD, absence of extraintestinal manifestations, or pouchitis. 2L/3L includes Vedolizumab, upadacitinib, or risankizumab-rzaa (one must be risankizumab-rzaa). 4L includes Mirikizumab-mrkz, guselkumab, or ustekinumab/biosimilar.
- Sequencing for UC: 1L Infliximab/biosimilar (preferred) or adalimumab/biosimilar; Vedolizumab may be used 1L for “moderate” UC, absence of extraintestinal manifestations, or pouchitis. 2L/3L includes Vedolizumab, tofacitinib, upadacitinib, etrasimod, ozanimod, or risankizumab-rzaa (one must be risankizumab-rzaa). 4L includes Mirikizumab-mrkz, guselkumab, or ustekinumab/biosimilar.
- Retesting: Routine retesting for TB, HBV, and HCV is not required for prescription renewals; consider retesting in high-risk patients.