Medical Drug Criteria (MDC)

Policy Num:       P1.002.001
Policy Name:     Entyvio® (vedolizumab) 
Policy ID:          [P1.002.001]  [Ac / Mg / M+ / P+]  [0.00.00]

Last Review:     December 16, 2024
Next Review:    December 20, 2024
 

Related MDC: NONE

Entyvio® (vedolizumab) 

SUMMARY

Vedolizumab is a recombinant human IgG1 monoclonal antibody produced in Chinese hamster ovaries. It binds to a human alpha 4 beta 7 integrin site and blocks the interaction of this integrin with mucosal addressin adhesion molecules. This inhibits the migration of memory T-lymphocytes across the endothelium into the inflamed gastrointestinal tissue. This interaction is thought to be an important contributor to the chronic inflammation of ulcerative colitis and Crohn's disease. 

POLICY STATEMENTS

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

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

Universal Criteria

• Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND

• 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 TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib, upadacitinib, etc.); AND

Crohn’s Disease  

• 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.); OR

• Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial on previous therapy with a TNF modifier such as adalimumab, certolizumab, or infliximab.

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis  

• Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, etc.); AND

• Patient has moderate (grade 2) to severe (grade 3-4) diarrhea or colitis related to their immunotherapy

POLICY GUIDELINES

Renewal Criteria

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

• 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

• 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  

• May not be renewe

DOSAGE/ADMINISTRATION

Recommended Dosage in Adults with Ulcerative Colitis and Crohn’s Disease

• Week 0: Administer ENTYVIO 300 mg by intravenous infusion over approximately
30 minutes [see Dosage and Administration.

• Week 2: Administer ENTYVIO 300 mg by intravenous infusion over approximately
30 minutes.

• Week 6: Patients may remain on ENTYVIO intravenous therapy or switch to
subcutaneous injection after receiving two ENTYVIO intravenous doses administered
at Week 0 and Week 2.

° Intravenous Infusion: Administer ENTYVIO 300 mg by intravenous infusion
over approximately 30 minutes and then every eight weeks thereafter.

° Subcutaneous Injection: Administer ENTYVIO 108 mg subcutaneously once
every 2 weeks.

• Discontinue therapy in patients who show no evidence of therapeutic benefit by
Week 14.

Patients currently receiving and responding to ENTYVIO intravenous therapy after Week 6 may also be switched to subcutaneous injection. Administer the first subcutaneous dose in place of the next scheduled intravenous infusion and every two weeks thereafter.

REQUIRED MEDICAL INFORMATION

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

EXCLUSION CRITERIA

None

BENEFIT APPLICATION

As stated in the policy.

OTHER CRITERIA

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Article (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

REFERENCES

1. Entyvio [package insert]. Lexington, MA 02421; Takeda Pharmaceuticals America, Inc;August 2021. Accessed September 2021.

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-pdf35109627942085.

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, 2021. 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 September 2021.

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/eccojcc/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-pdf66141667282885

CODES

APPLICABLE MODIFIERS

As per payment guidelines

POLICY HISTORY