WHA

Entyvio (vedolizumab)

Indications for Prior Authorization

Entyvio IV & SC (vedolizumab)
  • For diagnosis of Crohn's Disease (CD)
    Indicated in adults for the treatment of moderately to severely active Crohn's disease.

  • For diagnosis of Ulcerative Colitis (UC)
    Indicated in adults for the treatment of moderately to severely active ulcerative colitis.

Criteria

Entyvio IV

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 14 Weeks [1, A]
For diagnosis of Crohn's Disease (CD)

  • Diagnosis of moderately to severely active Crohn's disease
    • AND
  • One of the following [2, 3]:
    • Frequent diarrhea and abdominal pain
    • At least 10% weight loss
    • Complications such as obstruction, fever, abdominal mass
    • Abnormal lab values (e.g., C-reactive protein [CRP])
    • CD Activity Index (CDAI) greater than 220
    AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies [2, 3]:
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone)
    • methotrexate
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following:
      • Cimzia (certolizumab pegol)
      • One formulary adalimumab product*
      • One formulary ustekinumab product*
      • Omvoh (mirikizumab-mrkz)
      • Skyrizi (risankizumab-rzaa)
      • Rinvoq (upadacitinib)
      OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
    AND
  • Prescribed by or in consultation with a gastroenterologist
Entyvio SC

* This product will require prior authorization

Prior Authorization (Initial Authorization)

Length of Approval: 14 Weeks [1, A]
For diagnosis of Crohn's Disease (CD)

  • Diagnosis of moderately to severely active Crohn's disease
    • AND
  • One of the following:
    • Will be used as a maintenance dose following two doses of Entyvio IV* for induction
      • OR
    • Patient is currently established on Entyvio IV*
    AND
  • Prescribed by or in consultation with a gastroenterologist
Entyvio IV & SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Crohn's Disease (CD)

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
    • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
    • Reversal of high fecal output state
Entyvio IV

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 14 Weeks [1, A]
For diagnosis of Ulcerative Colitis (UC)

  • Diagnosis of moderately to severely active ulcerative colitis
    • AND
  • One of the following [4, 5]:
    • Greater than 6 stools per day
    • Frequent blood in the stools
    • Frequent urgency
    • Presence of ulcers
    • Abnormal lab values (e.g., hemoglobin, ESR, CRP)
    • Dependent on, or refractory to, corticosteroids
    AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies [4, 5]:
    • 6-mercaptopurine
    • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
    • Azathioprine
    • Corticosteroids (e.g., prednisone)
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following:
      • One formulary adalimumab product*
      • Simponi (golimumab)
      • One formulary ustekinumab product*
      • Omvoh (mirikizumab-mrkz)
      • Skyrizi (risankizumab-rzaa)
      • Tremfya (guselkumab)
      • Rinvoq (upadacitinib)
      • Xeljanz/XR (tofacitinib/ER)
      • Velsipity (etrasimod)
      OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
    AND
  • Prescribed by or in consultation with a gastroenterologist
Entyvio SC

* This product will require prior authorization

Prior Authorization (Initial Authorization)

Length of Approval: 14 Weeks [1, A]
For diagnosis of Ulcerative Colitis (UC)

  • Diagnosis of moderately to severely active ulcerative colitis
    • AND
  • One of the following:
    • Will be used as a maintenance dose following two doses of Entyvio IV* for induction
      • OR
    • Patient is currently established on Entyvio IV*
    AND
  • Prescribed by or in consultation with a gastroenterologist
Entyvio IV & SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ulcerative Colitis (UC)

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4, 5]:
    • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
    • Reversal of high fecal output state

  • Guideline ID
    GL-164924

  • Formulary
    premium

  • Effective date
    Apr 1, 2025

  • P&T approval date
    Jul 8, 2014

P & T Revisions

2025-02-09, 2025-02-09, 2025-01-15, 2024-12-01, 2024-11-27, 2024-09-08, 2024-07-30, 2024-06-24, 2024-05-30, 2024-05-01, 2024-04-24, 2024-03-07, 2023-12-02, 2023-11-14, 2023-09-03, 2023-07-05, 2023-07-05, 2023-02-01, 2022-10-23, 2022-09-08, 2022-08-02, 2022-04-07, 2021-09-03, 2020-09-18, 2020-08-16, 2019-10-31

  1. Entyvio Prescribing Information. Takeda Pharmaceuticals of America, Inc. Deerfield, IL. April 2024.
  2. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113:481-517.
  3. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508.
  4. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
  5. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.
  1. Entyvio should be discontinued in patients who do not show evidence of therapeutic benefit by week 14. [1]
  • 2025-02-09: Addition of Omvoh as another preferred alternative for CD
  • 2025-02-09: Addition of Velsipity as another preferred alternative for UC
  • 2025-01-15: Updated background table
  • 2024-12-01: Added Tremfya and Omvoh as additional preferred alternatives for UC; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
  • 2024-11-27: Added Tremfya and Omvoh as additional preferred alternatives for UC; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
  • 2024-09-08: Removed bypass verbiage for UC; annual review - no additional criteria changes
  • 2024-07-30: Addition of Skyrizi as an additional trial option for UC indication.
  • 2024-06-24: Addition of CD criteria for Entyvio SC. Updated background table to include CalPERS formulary and to specify BI manufacturer for adalimumab-adbm
  • 2024-05-30: Addition of CD criteria for Entyvio SC. Updated background table to include CalPERS formulary; no criteria changes
  • 2024-05-01: Addition of CD criteria for Entyvio SC
  • 2024-04-24: Updated verbiage in the steps to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2024-03-07: Updated verbiage in the steps to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2023-12-02: Addition of criteria for Entyvio SC
  • 2023-11-14: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-09-03: Annual review - no criteria changes
  • 2023-07-05: Addition of Rinvoq as another preferred step option for CD
  • 2023-07-05: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options
  • 2023-02-01: Addition of Amjevita as another preferred step option
  • 2022-10-23: Further clinical detail and criteria added
  • 2022-09-08: Annual review - removed criterion regarding concomitant use with Tysabri or TNF inhibitors; background updates
  • 2022-08-02: Added Skyrizi as an additional preferred step option for CD and removed the bypass verbiage
  • 2022-04-07: Addition of Rinvoq and Xeljanz/XR as preferred step options for UC
  • 2021-09-03: Annual review
  • 2020-09-18: Formulary strategy update to remove infliximab as a preferred step option and add bypass verbiage
  • 2020-08-16: Annual review - addition of Avsola to infliximab examples; updated indications per prescribing information; added continuation of therapy clause for the trial and failure requirement to align with other biologics with the same indications; background and reference updates
  • 2019-10-31: Updated step requirements for UC to TWO of the following: Humira, infliximab, Simponi, Stelara