Vedolizumab (Entyvio®)
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Adult patients with moderately to severely active ulcerative colitis (UC).
2. Adult patients with moderately to severely active Crohn’s disease (CD).
B. Compendial Uses
Immune checkpoint inhibitor-related toxicity
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Ulcerative colitis (UC) and Crohn’s disease (CD)
Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
B. Immune checkpoint inhibitor-related toxicity (initial requests only)
Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
III. PRESCRIBER SPECIALTIES
The medication must be prescribed by or in consultation with one of the following:
A. Crohn’s disease and ulcerative colitis: gastroenterologist
B. Immune checkpoint inhibitor-related toxicity: hematologist or oncologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Ulcerative colitis (UC)
Authorization of 12 months may be granted for adult members for treatment of moderately to severely active ulcerative colitis.
B. Crohn’s disease (CD)
Authorization of 12 months may be granted for adult members for treatment of moderately to severely active Crohn’s disease.
C. Immune checkpoint inhibitor-related toxicity
Authorization of 6 months may be granted for the treatment of immune checkpoint inhibitor-related diarrhea or colitis when either of the following criteria is met:
1. Member has had an inadequate response, intolerance, or contraindication to systemic corticosteroids or infliximab.
2. Member has moderate or severe diarrhea or colitis.
V. CONTINUATION OF THERAPY
A. Ulcerative colitis (UC)
1. Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain remission.
2. Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
i. Stool frequency
ii. Rectal bleeding
iii. Urgency of defecation
iv. C-reactive protein (CRP)
v. Fecal calprotectin (FC)
vi. Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound
vii. Improvement on a disease activity scoring tool (e.g., Ulcerative Colitis Endoscopic Index of Severity [UCEIS], Mayo score)
B. Crohn’s disease (CD)
1. Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain remission.
2. Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
i. Abdominal pain or tenderness
ii. Diarrhea
iii. Body weight
iv. Abdominal mass
v. Hematocrit
vi. Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound
vii. Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score)
C. Immune checkpoint inhibitor-related toxicity
All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
VI. OTHER
For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug.
VII. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
VIII. APPENDIX
.
Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate
1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
2. Drug interaction
3. Risk of treatment-related toxicity
4. Pregnancy or currently planning pregnancy
5. Breastfeeding
6. Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)
7. Hypersensitivity
8. History of intolerance or adverse event
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Entyvio (Vedolizumab) |
Crohn's Disease |
Route of Administration: Intravenous ≥18 Years Initial: 300mg on weeks 0, 2, and 6, followed by Maintenance: 300mg every 8 weeks |
Entyvio (Vedolizumab) |
Immune Checkpoint Inhibitor-Related Toxicity |
Route of Administration: Intravenous 300mg on weeks 0, 2, and 6, then every 8 weeks |
Entyvio (Vedolizumab) |
Ulcerative Colitis |
Route of Administration: Intravenous ≥18 Years Initial: 300mg intravenously on weeks 0, 2, and 6, followed by Maintenance: 300mg intravenously every 8 weeks |
Entyvio (Vedolizumab) |
Ulcerative Colitis |
Route of Administration: Intravenous/subcutaneous ≥18 Years Initial: 300mg intravenously on weeks 0, 2, followed by Maintenance beginning week 6: 108mg subcutaneously every 2 weeks |
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.
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).
1. Entyvio [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; June 2022.
2. Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
3. Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
4. Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114:384-413.
5. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 16, 2023.
6. NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®). Management of Immunotherapy-Related Toxicities. Version 1.2022. Available at: www.nccn.org. Accessed January 16, 2023.
7. Schneider BJ, Naidoo J, Santomasso BD, et al. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Guideline Update. J Clin Oncol. 2021; 39(36):4073-4126.
8. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020; 158:1450-1461.
9. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology. 2021; 160: 2496- 2508.
ORIGINAL EFFECTIVE DATE: 6/11/2014
MOST RECENT REVIEW DATE: 4/1/2024
ID_CHS
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.
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