BlueCross BlueShield of Tennessee Medical Policy Manual

Vedolizumab

NDC CODE(S)

67464-0300-20 – Entyvio 300mg single use vial  (Takeda Pharmaceuticals America)

DESCRIPTION

Vedolizumab is a humanized monoclonal antibody which acts as an integrin receptor antagonist.  It binds specifically to the alpha-4 beta-7 (α4ß7) integrin, blocking interaction with mucosal address in cell adhesion molecule-1 (MAdCAM-1) and inhibiting migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue.

The α4ß7 integrin is expressed on some memory T-lymphocytes which preferentially migrate into the gastrointestinal tract through the actions of MAdCAM-1.  The interaction of the α4ß7 integrin with MAdCAM-1 is implicated as a major contributor to the chronic inflammation associated with ulcerative colitis and Crohn’s disease.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

Loading dose - 300 mg at weeks 0, 2, & 6

Maintenance dose - 300 mg every 8 weeks thereafter

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of vedolizumab for the treatment or prevention of any other disease or condition.

SOURCES

Lexi-Comp Online. (2016, October). AHFS DI. Vedolizumab. Retrieved November 29, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Vedolizumab. Retrieved November 29, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, July). Center for Drug Evaluation and Research. Product Information. Entyvio® (Vedolizumab). Retrieved November 29, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/11/2014

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Vedolizumab (Entyvio ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #8

  1. Is the individual 18 years of age or older and ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of ANY ONE of the following that is moderately to severely active?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. As a requirement of BCBST’s P&T committee, has a prior trial of infliximab (Remicade®), ustekinumab (Stelara®) or golimumab injection (Simponi® Aria, Simponi®) as a tumor necrosis factor-blocker failed, is contraindicated or not been tolerated?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have documentation that there is NOT or will NOT be concurrent treatment with a biologic response modifier such as etanercept (Enbrel®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), or infliximab (Remicade®), or natalizumab (Tysabri®) while on treatment with vedolizumab?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has the individual had prior with documentation of failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial on previous therapy with ANY ONE of the following conventional oral agents?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 300 billable units at weeks 0, 2, and 6 with 300 billable units every 8 weeks, with dosage of 300 mg at weeks 0, 2, and 6 and maintenance dosage of 300 mg every 8 weeks, for an authorization period of 14 weeks initially with a possible renewal for 6 months thereafter?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 7, including continued monitoring for TB and other active infections?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug such as anaphylaxis or other serious allergic reactions, severe infections, Progressive Multifocal Leukoencephalopathy (PML), jaundice or other evidence of significant liver injury?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. A diagnosis of ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.