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Entyvio (vedolizumab)

Policy Number: PH-0202

Intravenous

Last Review Date: 10/02/2018

Date of Origin:  06/24/2014

Dates Reviewed:  09/2014, 03/2015, 6/2015, 9/2015, 12/2015, 03/2016, 05/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018

 

  1. Length of Authorization
  • Coverage will be provided for 14 weeks initially and may be renewed every 6 months thereafter.
  • Immune Checkpoint Inhibitor related diarrhea/colitis: 3 doses and may not be renewed
  1. Dosing Limits
  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:

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 8 weeks (56 days)
  1. Max Units (per dose and over time) [Medical Benefit]:

Loading Dose:              

  • 300 billable units at weeks 0, 2, & 6

Maintenance Dose:

  • 300 billable units every 8 weeks
  1. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND
  • Patient aged 18 years or older; AND
  • Patient is free of any active, severe infections; AND
  • Patient has been screened for tuberculosis according to local practice (if applicable); AND
  • Patient is not on concurrent treatment with another TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib); AND
  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

Crohn’s disease †

  • Documented moderate to severe 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 †

  • Documented moderate to severe 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)

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, etc.); AND
  • Patient has diarrhea or colitis related to their immunotherapy; AND
  • Documented moderate or severe disease; AND
  • Patient’s condition is refractory to infliximab.

FDA Approved Indication(s)

  1. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet criteria identified in section III; AND
  • Patient is receiving ongoing monitoring for presence of TB or other active infections; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: anaphylaxis or other serious allergic 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 renewed
  1. Dosage/Administration

Indication

Dose

Ulcerative Colitis and Crohn’s Disease

Loading dose:

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

Maintenance dose:

300 mg, intravenously, every 8 weeks thereafter

Immune Checkpoint Inhibitor related diarrhea/colitis

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

  1. Billing Code/Availability Information

Jcode:

  • J3380 - Injection, vedolizumab, 1 mg; 1 billable unit = 1 mg

NDC:

  • Entyvio 300 mg single use vial: 67464-0300-xx
  1. References
  1. Entyvio [package insert]. Deerfield, IL; Takeda Pharmaceuticals America, Inc; February  2018. Accessed September 2018.
  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):501-2
  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. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) vedolizumab. National Comprehensive Cancer Network, 2018. 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 2018.
  13. 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.

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)

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

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): 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, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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