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Date Printed: June 28, 2017: 11:41 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-18

Original Effective Date: 09/15/14

Reviewed: 08/10/16

Revised: 05/15/17

Subject: Vedolizumab (Entyvio®) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Vedolizumab (Entyvio®) was approved by the US Food and Drug Administration (FDA) in May 2014 for the treatment of moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn’s disease in adults who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Vedolizumab binds to and blocks the interaction between integrin alpha-4-beta-7 and mucosal addressin cell adhesion molecule-1 (MAdCAM-1) in the gut which inhibits the migration of specific memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. The action reduces the chronic inflammatory process present in both UC and Crohn’s disease. FDA approval was based on the results of three pivotal trials: GEMINI 1 (UC) and GEMINI 2 and GEMINI 3 (Crohn’s disease).

POSITION STATEMENT:

NOTE: If the member has had an inadequate therapeutic response to previous biologic therapy that is FDA-approved for CD or UC, they are not required to try additional non-biologic prerequisite therapy (e.g., for UC, if the member has previously had an inadequate therapeutic response to infliximab, but does not have a history of corticosteroid and sulfasalazine use, they do not have to try these two drugs to meet medical necessity criteria).

Initiation of vedolizumab (Entyvio) meets the definition of medical necessity when used to treat either of the following conditions and ALL associated criteria are met:

1. Crohn’s disease (CD)

a. Member has a diagnosis of moderately to severely active CD

b. The member has had an inadequate therapeutic response or has a contraindication to ONE or more conventional therapies (e.g., sulfasalazine, mesalamine products, aminosalicylate, corticosteroids, immunosuppressants [6-mercaptopurine, azathioprine, cyclosporine, methotrexate] (the specific contraindication must be provided)

c. Vedolizumab will not be administered concomitantly with ANY of the following:

i. abatacept (Orencia)

ii. adalimumab (Humira)

iii. anakinra (Kineret)

iv. apremilast (Otezla)

v. certolizumab (Cimzia)

vi. etanercept (Enbrel)

vii. golimumab (Simponi)

viii. infliximab (Remicade)

ix. ixekizumab (Taltz)

x. natalizumab (Tysabri)

xi. secukinumab (Cosentyx)

xii. tocilizumab (Actemra)

xiii. tofacitinib (Xeljanz)

xiv. ustekinumab (Stelara)

d. The member is 12 years of age or older

e. The dose does not exceed 300 mg at weeks 0, 2, 6 and 14.

2. Ulcerative colitis (UC)

a. Member’s disease is moderately to severely active

b. EITHER of the following (“i” or ii”):

i. The member has had an inadequate therapeutic response or has a contraindication to systemic corticosteroid therapy (the specific contraindication must be provided)

ii. Member is dependent on systemic corticosteroids [i.e., unable to successfully taper corticosteroids to less than 10 mg of prednisone (or equivalent) within 3 months of initiation without return of symptoms]

c. The member has had an inadequate therapeutic response to ANY or has a contraindication to ALL of the following (the specific contraindications must be provided):

i. Oral aminosalicylates (i.e., sulfasalazine, olsalazine, mesalamine, or balsalazide)

ii. Non-oral aminosalicylates (e.g., enema or suppository)

iii. Thiopurine therapy (e.g., azathioprine or 6-mercaptopurine [6-MP])

d. Vedolizumab will not be administered concomitantly with ANY of the following:

i. abatacept (Orencia)

ii. adalimumab (Humira)

iii. anakinra (Kineret)

iv. apremilast (Otezla)

v. certolizumab (Cimzia)

vi. etanercept (Enbrel)

vii. golimumab (Simponi)

viii. infliximab (Remicade)

ix. ixekizumab (Taltz)

x. natalizumab (Tysabri)

xi. secukinumab (Cosentyx)

xii. tocilizumab (Actemra)

xiii. tofacitinib (Xeljanz)

xiv. ustekinumab (Stelara)

d. The member is 12 years of age or older

e. The dose does not exceed 300 mg at weeks 0, 2, 6 and 14

Approval duration: 14 weeks (both indications)

Continuation of vedolizumab meets the definition of medical necessity when ALL of the following criteria are met:

1. An authorization/reauthorization for vedolizumab has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of UC or Crohn’s disease, OR the member previously met ALL indication-specific initiation criteria

2. The member has demonstrated a beneficial response to therapy

3. Vedolizumab will not be administered concomitantly with ANY of the following

a. abatacept (Orencia)

b. adalimumab (Humira)

c. anakinra (Kineret)

d. apremilast (Otezla)

e. certolizumab (Cimzia)

f. etanercept (Enbrel)

g. golimumab (Simponi)

h. infliximab (Remicade)

i. ixekizumab (Taltz)

j. natalizumab (Tysabri)

k. secukinumab (Cosentyx)

l. tocilizumab (Actemra)

m. tofacitinib (Xeljanz)

n. ustekinumab (Stelara)

4. The dosage does not exceed 300 mg every 8 weeks

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Vedolizumab is indicated for the treatment of adults with either of the following:

  1. Moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids
  2. Moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids

The recommended dose for both indication sis 300 mg infused intravenously over approximately 30 minutes at weeks 0, 2, 6 and then every eight weeks. The manufacturer recommends discontinuation if there is no evidence of benefit at week 14.

Product availability: vedolizumab is supplied 300 mg/20 mL vial (must be reconstituted)

PRECAUTIONS:

Contraindication:

Previous serous or severe hypersensitivity reaction to vedolizumab or any of its excipients

Warnings:

  1. Hypersensitivity Reactions (including anaphylaxis): Discontinue vedolizumab if anaphylaxis or other serious allergic reactions occur.
  2. Infections: Treatment with vedolizumab is not recommended in persons with active, severe infections until the infections are controlled. Consider withholding vedolizumab in those who develop a severe infection while on treatment with vedolizumab.
  3. Progressive Multifocal Leukoencephalopathy: Although no cases have been observed in vedolizumab clinical trials, JCV infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in persons treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor individuals administered vedolizumab for any new or worsening neurological signs or symptoms.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J3380

Injection, vedolizumab, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity

K50.00 – K50.919

Crohn’s disease (regional enteritis)

K51.00 – K51.919

Ulcerative colitis

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Crohn's Disease: is an inflammatory bowel disease characterized by severe, chronic inflammation of the intestinal wall or any portion of the gastrointestinal tract. The lower portion of the small intestine (ileum) and the rectum are most commonly affected by this disorder. Symptoms may include watery diarrhea and abdominal pain. The symptoms of Crohn's Disease can be difficult to manage and diagnosis is often delayed.

DMARDs: An acronym for disease-modifying antirheumatic drugs.

Mild-Moderate Crohn’s Disease: Mild-moderate Crohn's disease applies to ambulatory members able to tolerate oral alimentation without manifestations of dehydration, toxicity (high fevers, rigors, prostration), abdominal tenderness, painful mass, obstruction, or >10% weight loss.

Moderate-Severe Crohn’s Disease: Moderate-severe disease applies to members who have failed to respond to treatment for mild-moderate disease or those with more prominent symptoms of fevers, significant weight loss, abdominal pain or tenderness, intermittent nausea or vomiting (without obstructive findings), or significant anemia.

Ulcerative colitis: a chronic inflammatory disease of the colon that is of unknown cause and is characterized by diarrhea with discharge of mucus and blood, cramping abdominal pain, and inflammation and edema of the mucous membrane with patches of ulceration.

RELATED GUIDELINES:

Abatacept (Orencia), 09-J0000-67

Adalimumab (Humira), 09-J0000-46

Anakinra (Kineret), 09-J0000-45

Etanercept (Enbrel), 09-J0000-38

Golimumab (Simponi®, Simponi® Aria™), 09-J1000-11

Infliximab (Remicade®) and Infliximab-dyyb (Inflectra®), 09-J0000-39

Natalizumab (Tysabri®) Injection, 09-J0000-73

Rituximab (Rituxan), 09-J0000-59

Tocilizumab (Actemra®) Injection, 09-J1000-21

Tofacitinib (Xeljanz), 09-J1000-86

Ustekinumab (Stelara), 09-J1000-16

OTHER:

DMARDs

DMARD Generic Name

DMARD Brand Name

Auranofin (oral gold)

Ridaura

Azathioprine

Imuran

Cyclophosphamide

Cytoxan

Cyclosporine

Neoral, Sandimmune

Gold sodium thiomalate (injectable gold)

Myochrysine

Hydroxychloroquine sulfate

Plaquenil

Leflunomide

Arava

Methotrexate

Rheumatrex, Trexall

Minocycline

Minocin

Penicillamine

Cuprimine, Depen

Sulfasalazine

Azulfidine, Azulfidine EN-Tabs

REFERENCES:

  1. Bickston SJ, Behm BW, Tsoulis DJ, et al. Vedolizumab for induction and maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2014 Aug 8;8:CD007571
  2. Buchner AM, Blonski W, Lichtenstein GR. Update on the management of Crohn’s disease. Curr Gastroenterol Rep 2011;13:465-74.
  3. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com. Accessed 7/14/16.
  4. Conrad MA, Stein RE, Maxwell EC, et al. Vedolizumab Therapy in Severe Pediatric Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Oct;22(10):2425-31.
  5. Danese S, Fiorino G, Peyrin-Biroulet L, et al. Biological agents for moderately to severely active ulcerative colitis. Ann Intern Med 2014; 160: 704-11.
  6. Entyvio (vedolizumab) [package insert]. Takeda Pharmaceuticals America, Inc. Deerfield (IL): May 2014.
  7. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013;369(8):699-710.
  8. Hazelwood GS, Rezaie A, Borman M, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn’s disease: a network meta-analysis. Gastroenterology 2014; doi: 10.1053/j.gastro.2014.10.011.
  9. Kornbluth A, Sachar DB, et al. Erratum: ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010;105:500-23.
  10. LeBlanc K, Mosli M, Parker CE, MacDonald JK. The impact of biological interventions for ulcerative colitis on health-related quality of life. Cochrane Database Syst Rev. 2015 Sep 22;9:CD008655.
  11. Lichtenstein GR, Hanauer SB, Sanborn WJ, et al. Management of Crohn’s disease in adults. Am J Gastroenterol 2009;104(2):465-83.
  12. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 7/14/16.
  13. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2013;369(8):711-721.
  14. Singh N, Rabizadeh S, Jossen J, et al. Multi-Center Experience of Vedolizumab Effectiveness in Pediatric Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Sep;22(9):2121-6.
  15. 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.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 4/12/17.

GUIDELINE UPDATE INFORMATION:

09/15/14

New Medical Coverage Guideline.

09/15/15

Review and revision to guideline; consisting of updating position statement, billing/coding, and references.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual HCPCS coding update: added code J3380 and deleted codes C9026 and J3590.

09/15/16

Review and revision to guideline consisting of updating position statement and references.

5/15/17

Revision to guideline consisting of updating the references and position statement to allow use in adolescents (age 12 to 17 years).

Date Printed: June 28, 2017: 11:41 PM