Pharmacy Prior Authorization Criteria

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*
• 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)
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

P & T Revisions

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

References

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.

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End Notes

1. Entyvio should be discontinued in patients who do not show evidence of therapeutic benefit by week 14. [1]

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Revision History

• 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

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