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Entyvio™ (vedolizumab)

Policy Number: PH-0202

Intravenous

 Last Review Date: 05/02/2024

Date of Origin:  06/24/2014

Dates Reviewed:  09/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 05/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 10/2019, 10/2020, 10/2021, 04/2022, 08/2023, 10/2023, 11/2023, 05/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage will be provided for 14 weeks initially and may be renewed every 6 months thereafter unless otherwise specified.

  • Dose escalation requests for Crohn’s Disease and Ulcerative Colitis: Coverage will be provided for 3 months and may be renewed every 6 months thereafter (see Section V for therapy continuation details).
  • Therapy for the Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis: Coverage will be provided for 3 doses total and may not be renewed.
  • Therapy for Crohn’s Disease and Ulcerative Colitis in patients who will be receiving subcutaneous maintenance doses: Coverage will be provided for 2 intravenous doses and 4 subcutaneous doses [see Entyvio SQ policy – Document Number: IC-0733]
  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:

Loading Dose:             

  • Entyvio 300 mg single use vial: 1 vial at weeks 0, 2, & 6 (3 vials total per 42 days)

Maintenance Dose:

  • Entyvio 300 mg single use vial: 1 vial every 4 weeks (28 days)
  1. Max Units (per dose and over time) [HCPCS Unit]:

Crohn’s Disease and Ulcerative Colitis:

  • Loading Dose: 300 billable units (300 mg) at weeks 0, 2, & 6
  • Maintenance Dose: 300 billable units (300 mg) every 4 weeks

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis

  • 300 billable units (300 mg) at weeks 0, 2, & 6
  1. Initial Approval Criteria 1

Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information.

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND
  • Patient is up to date with all vaccinations, in accordance with current immunization guidelines, prior to initiating therapy; AND

Universal Criteria 1

  • Patient does not have an active infection, including clinically important localized infections; AND
  • Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
  • Patient is not on concurrent treatment with another integrin receptor antagonist, TNF-inhibitor, IL-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib, upadacitinib, abrocitinib, deucravacitinib, etc.); AND

Crohn’s Disease † 1,2,15,16

  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
  • Documented moderate to severe active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate, etc.)

Ulcerative Colitis † 1,12,18-20

  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
  • Documented moderate to severe active disease; AND
  • Documented failure or ineffective response to a minimum 3-month trial of conventional therapy [aminosalicylates, corticosteroids, or immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate, etc.)] at maximum tolerated doses, unless there is a contraindication or intolerance to use

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis 13,14

  • Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, tremelimumab, dostarlimab, retifanlimab, etc.); AND
    • Patient has mild (G1) diarrhea or colitis related to their immunotherapy with persistent or progressive symptoms and a positive lactoferrin/calprotectin; OR
    • Patient has moderate (G2) to severe (G3-4) diarrhea or colitis related to their immunotherapy

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet universal and indication-specific criteria as identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: anaphylaxis or other serious allergic, severe infusion-related or hypersensitivity reactions, severe infections, progressive multifocal leukoencephalopathy (PML), jaundice or other evidence of significant liver injury, etc.; AND

Crohn’s Disease 11,16

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g., an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].

Ulcerative Colitis 9-11,20

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g., an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score].

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis 13,14

  • May not be renewed.
  1. Dosage/Administration 1,13,17

Indication

Dose

Crohn’s Disease and Ulcerative Colitis

Induction dose:

  • Patients who will be receiving intravenous maintenance doses: Administer 300 mg intravenously at weeks 0, 2, & 6 (see maintenance dosing below)
  • Patients who will be receiving subcutaneous maintenance doses: Administer 300 mg intravenously at weeks 0 and 2 (see Entyvio SQ policy [Document Number: IC-0733] for maintenance dosing starting at week 6).

Maintenance dose:

Administer 300 mg intravenously every 8 weeks thereafter

***NOTE: Requests for higher intravenous dosing must be reviewed according to the dose escalation information below

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis

Administer 300 mg intravenously at weeks 0, 2, & 6

  • Dose escalation (up to the maximum dose and frequency specified below) may occur upon clinical review on a case-by-case basis provided that the patient has:
  • Shown an initial response to therapy; AND
  • Received the three loading doses at the dose AND interval specified above; AND
  • Received a minimum of one maintenance dose at the dose AND interval specified above; AND
  • Responded to therapy (by treatment week 14*) with subsequent loss of response; AND
  • Dose escalation must not exceed the following limits:
  • 300 mg every 4 weeks
  • Coverage will be provided for 3 months with continued approval (as specified in Sections I & IV) contingent upon demonstration of clinical improvement and vedolizumab levels (if available)**
    • Patients who do not regain response should discontinue therapy
    • Patients who are responding to therapy may continue with their current dosing**

*Note:

  • Request for dose escalation prior to week 14 will be evaluated considering the patient’s clinical picture regarding severity of inflammation, factors which may result in subtherapeutic response to standard dosing (e.g., obesity, hypoalbuminemia, prior TNF-I exposure), timing of response and breakthrough/loss of response, AND one of the following:
    • vedolizumab trough (if available)** at week 14 is <14 micrograms/mL; OR
    • CRP elevation or calprotectin >150

**vedolizumab trough levels must be obtained (if this is a covered test under the benefit).

  • Patients whose trough is 14-20 micrograms/mL may continue with 300 mg every 4 weeks.
  • Patients with a trough >20 micrograms/mL must increase the interval between administrations from 4 weeks to 6 weeks. Response should be assessed after receipt of 3 doses at this every 6-week interval. Those patients demonstrating loss of response may then decrease the interval back to 300 mg every 4 weeks.
  • Patients whose trough is <14 micrograms/mL are candidates to decrease the interval between administrations from 8 weeks to 4 weeks
  1. Billing Code/Availability Information

 HCPCS Code:

  • J3380 – Injection, vedolizumab, intravenous, 1 mg; 1 billable unit = 1 mg

NDC:

  • Entyvio 300 mg single use vial: 67464-0300-xx
  1. References
  1. Entyvio [package insert]. Lexington, MA 02421; Takeda Pharmaceuticals U.S.A., Inc.; April 2024. Accessed April 2024.
  2. Lichtenstein GR, Loftus EV, Isaacs K, et al. American College of Gastroenterology Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113: 481-517. doi: 10.1038/ajg.2018.27; published online 27 March 2018.
  3. Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
  4. Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012 Dec;6(10):991-1030.
  5. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
  6. Gomollón F, Dignass A, Annese V, et al. EUROPEAN Evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management. J Crohns Colitis. 2016 Sep 22. pii: jjw168.
  7. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
  8. National Institute for Health and Care Excellence. NICE 2012. Crohn’s Disease: Management. Published 10 October 2012. Clinical Guideline [CG152]. https://www.nice.org.uk/guidance/cg152/resources/crohns-disease-management-pdf-35109627942085.
  9. Lewis JD, Chuai S, Nessel L, et al. Use of the Non-invasive Components of the Mayo Score to Assess Clinical Response in Ulcerative Colitis. Inflamm Bowel Dis. 2008 Dec; 14(12): 1660–1666. doi:  10.1002/ibd.20520
  10. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
  11. Walsh AJ, Bryant RV, Travis SPL. Current best practice for disease activity assessment in IBD. Nature Reviews Gastroenterology & Hepatology  13, 567–579 (2016) doi:10.1038/nrgastro.2016.128
  12. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019 Mar;114(3):384-413.
  13. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) vedolizumab. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2023.
  14. Bergqvist, V, Hertervig E, Gedeon P, et al. Vedolizumab treatment for immune checkpoint inhibitor-induced enterocolitis. Cancer Immunology Immunotherapy 66: 581-592, No. 5, May 2017.
  15. Torres J, Bonovas S, Doherty G, et al. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohn’s Colitis. 2020 Jan 1;14(1):4-22. doi: 10.1093/ecco-jcc/jjz180. PMID: 31711158.
  16. National Institute for Health and Care Excellence. NICE 2019. Crohn’s Disease: Management. Published 03 May 2019. Clinical Guideline [NG129]. https://www.nice.org.uk/guidance/ng129/resources/crohns-disease-management-pdf-66141667282885
  17. Vermeire S, Loftus EV, Colombel JF, et al. Long-term Efficacy of Vedolizumab for Crohn’s Disease, Journal of Crohn's and Colitis, Volume 11, Issue 4, 1 April 2017, Pages 412–424, https://doi.org/10.1093/ecco-jcc/jjw176
  18. National Institute for Health and Care Excellence. NICE 2019. Ulcerative colitis: management. Published 03 May 2019. NICE guideline [NG130]. https://www.nice.org.uk/guidance/ng130
  19. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450-1461. doi:10.1053/j.gastro.2020.01.006.
  20. Raine T, Bonovas S, Burisch J, et al. ECCO Guidelines on therapeutics in ulcerative colitis: medical treatment. J Crohns Colitis. 2022 Jan 28. 16 (1):2-17. Doi: 10.1093/ecco-jcc/jjab178

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

K50.00

Crohn's disease of small intestine without complications

K50.011

Crohn's disease of small intestine with rectal bleeding

K50.012

Crohn's disease of small intestine with intestinal obstruction

K50.013

Crohn's disease of small intestine with fistula

K50.014

Crohn's disease of small intestine with abscess

K50.018

Crohn's disease of small intestine with other complication

K50.019

Crohn's disease of small intestine with unspecified complications

K50.10

Crohn's disease of large intestine without complications

K50.111

Crohn's disease of large intestine with rectal bleeding

K50.112

Crohn's disease of large intestine with intestinal obstruction

K50.113

Crohn's disease of large intestine with fistula

K50.114

Crohn's disease of large intestine with abscess

K50.118

Crohn's disease of large intestine with other complication

K50.119

Crohn's disease of large intestine with unspecified complications

K50.80

Crohn's disease of both small and large intestine without complications

K50.811

Crohn's disease of both small and large intestine with rectal bleeding

K50.812

Crohn's disease of both small and large intestine with intestinal obstruction

K50.813

Crohn's disease of both small and large intestine with fistula

K50.814

Crohn's disease of both small and large intestine with abscess

K50.818

Crohn's disease of both small and large intestine with other complication

K50.819

Crohn's disease of both small and large intestine with unspecified complications

K50.90

Crohn's disease, unspecified, without complications

K50.911

Crohn's disease, unspecified, with rectal bleeding

K50.912

Crohn's disease, unspecified, with intestinal obstruction

K50.913

Crohn's disease, unspecified, with fistula

K50.914

Crohn's disease, unspecified, with abscess

K50.918

Crohn's disease, unspecified, with other complication

K50.919

Crohn's disease, unspecified, with unspecified complications

K51.00

Ulcerative (chronic) pancolitis without complications

K51.011

Ulcerative (chronic) pancolitis with rectal bleeding

K51.012

Ulcerative (chronic) pancolitis with intestinal obstruction

K51.013

Ulcerative (chronic) pancolitis with fistula

K51.014

Ulcerative (chronic) pancolitis with abscess

K51.018

Ulcerative (chronic) pancolitis with other complication

K51.019

Ulcerative (chronic) pancolitis with unspecified complications

K51.20

Ulcerative (chronic) proctitis without complications

K51.211

Ulcerative (chronic) proctitis with rectal bleeding

K51.212

Ulcerative (chronic) proctitis with intestinal obstruction

K51.213

Ulcerative (chronic) proctitis with fistula

K51.214

Ulcerative (chronic) proctitis with abscess

K51.218

Ulcerative (chronic) proctitis with other complication

K51.219

Ulcerative (chronic) proctitis with unspecified complications

K51.30

Ulcerative (chronic) rectosigmoiditis without complications

K51.311

Ulcerative (chronic) rectosigmoiditis with rectal bleeding

K51.312

Ulcerative (chronic) rectosigmoiditis with intestinal obstruction

K51.313

Ulcerative (chronic) rectosigmoiditis with fistula

K51.314

Ulcerative (chronic) rectosigmoiditis with abscess

K51.318

Ulcerative (chronic) rectosigmoiditis with other complication

K51.319

Ulcerative (chronic) rectosigmoiditis with unspecified complications

K51.50

Left sided colitis without complications

K51.511

Left sided colitis with rectal bleeding

K51.512

Left sided colitis with intestinal obstruction

K51.513

Left sided colitis with fistula

K51.514

Left sided colitis with abscess

K51.518

Left sided colitis with other complication

K51.519

Left sided colitis with unspecified complications

K51.80

Other ulcerative colitis without complications

K51.811

Other ulcerative colitis with rectal bleeding

K51.812

Other ulcerative colitis with intestinal obstruction

K51.813

Other ulcerative colitis with fistula

K51.814

Other ulcerative colitis with abscess

K51.818

Other ulcerative colitis with other complication

K51.819

Other ulcerative colitis with unspecified complications

K51.90

Ulcerative colitis, unspecified, without complications

K51.911

Ulcerative colitis, unspecified with rectal bleeding

K51.912

Ulcerative colitis, unspecified with intestinal obstruction

K51.913

Ulcerative colitis, unspecified with fistula

K51.914

Ulcerative colitis, unspecified with abscess

K51.918

Ulcerative colitis, unspecified with other complication

K51.919

Ulcerative colitis, unspecified with unspecified complications

K52.1

Toxic gastroenteritis and colitis

R19.7

Diarrhea, unspecified

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC