Subject:
Vedolizumab (Entyvio™)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Entyvio™ (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1).
The α4β7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue.
Vedolizumab is currently marketed as Entyvio™ by Takeda Pharmaceuticals America, Inc.
On May 19, 2014, the FDA approve Entyvio™ for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, achieving corticosteroid-free remission for the treatment of adult patients with moderately to severely active Ulcerative Colitis (UC) 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: and for achieving clinical response, achieving clinical remission, achieving corticosteroid-free remission in adult patients with moderately to severely active Crohn’s Disease (CD) 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:
Crohn's disease is a chronic, incurable inflammatory bowel disease that causes diarrhea, cramping and abdominal pain, and in some cases fistula(e) leading from the intestine to the skin. Conventional treatments for Crohn’s disease include corticosteroids and other immunosuppressants, and antibiotics. Entyvio™ is an integrin receptor antagonist that blocks the interaction of α4β7 integrin with MAdCAM-1. The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Entyvio™ (vedolizumab) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
I. Please refer to a separate policy on Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) under the Drug Section.
II. Prior to starting therapy with Entyvio™ (vedolizumab) the following must be documented:
- Member has been tested for latent tuberculosis (TB) AND if positive the patient has begun therapy for latent TB; AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g. gastroenterologist) or has consulted with a specialist in the area of the patient’s diagnosis
III. Entyvio™ (vedolizumab) is medically necessary for the following FDA-approved indications when all of the following criteria are met:
A. Adult Ulcerative Colitis (UC)
i. Inducing and maintaining clinical response, inducing and maintaining clinical remission, improving the endoscopic appearance of the mucosa, and achieving corticosteroid-free remission in adult patients with moderately to severely active ulcerative colitis who have had:
- an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, metronidazole, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3-months or has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC; OR
- Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of UC; 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(Humira), golimumab (Simponi), or infliximab (Remicade)
B. Adult Crohn’s Disease (CD)
i. Achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission in adult patients with moderately to severely active Crohn’s disease who have had:
- trial and failure of ONE oral immunosuppressive therapy for at least 3 months or has a contraindication to or are unable to tolerate ALL conventional therapy (i.e., 6-mercaptopurine, aminosalicylates, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], mesalamine, methotrexate, sulfasalazine); OR
- Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of CD; 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(Humira), golimumab (Simponi), or infliximab (Remicade)
IV. When medical necessity criteria are met, Entyvio™ (vedolizumab) injections will be approved for 14 weeks based on the FDA recommendations:
A. Adult Ulcerative Colitis AND Adult Crohn’s Disease
i. 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.
ii. Discontinue Entyvio™ (vedolizumab) in patients who do not show evidence of therapeutic benefit by week 14.
[INFORMATIONAL NOTE:
Entyvio™ must be reconstituted with Sterile Water for injection and must dilute in 250 mL of sterile 0.9% Sodium Chloride injection prior to administration. Administer infusion solution within four hours of reconstitution and dilution.
As per the FDA approved package insert, prior to initiating therapy, patients should be brought up to date with all immunizations according to current immunization guidelines.]
V. Continued therapy with Entyvio™ (vedolizumab) will be considered annually if the following criteria are met:
a. Member continues to meet initial review criteria; AND
b. Member showed disease response as indicated by improvement in signs and symptoms compared to baseline (i.e. slowing of disease progression or decrease in symptom severity and/or frequency); AND
c. Absence of unacceptable toxicity from the drug (e.g: severe infections, progressive multifocal leukoencephalopathy (PML), hypersensitivity)
VI. When medically necessary, Entyvio will be approved for the following off-label indications:
· Management of Immunotherapy-Related Toxicities - Immune Checkpoint Inhibitor-Related Toxicities
i. Consider for management of severe (G3-4) immunotherapy-related diarrhea or colitis that is refractory to infliximab
VII. The combined use of Entyvio™ (vedolizumab) and a TNF, IL-1 inhibitor, or T-cell modulator (such as adalimumab, etanercept, abatacept or anakinra) ,or other non-biologic agents (i.e., Otezla, Xeljanz, Olumiant) increases the risk of adverse events and has no additional benefit in efficacy; therefore, combination use is not medically necessary.
VIII. The combined use of Entyvio™ (vedolizumab) and Tysabri™(natalizumab), another integrin receptor antagonist, increases the risk of adverse events such as PML and other infections; therefore, combination use is not medically necessary.
[INFORMATIONAL NOTE: On June 3, 2008, the FDA issued an early warning communication about an ongoing safety review involving the association of Tumor Necrosis Factor (TNF) blockers and the development of lymphomas and other cancers among children and young adults. Over a ten-year interval using the FDA’s adverse event reporting system, reports have been described cancer occurring in children using TNF blockers when they were 18 years of age or less to treat juvenile idiopathic arthritis, Crohn’s disease, and other diseases. Until the evaluation is complete and further long term studies have been conducted, caution should be advised in the use of TNF blockers in children and young adults.
As per the FDA approved package insert, Entyvio should not be used in combination with Tysabri]
IX. All other uses of Entyvio™ (vedolizumab) are considered investigational, including but not limited to, HIV.
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon Policy.
**Note: Bullet 1 of the policy section referring to Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) does not apply for Medicare Advantage Products.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Entyvio™ (Vedolizumab)
Vedolizumab (Entyvio™)
Ulcerative Colitis, Entyvio for
Crohn’s Disease, Entyvio for
References:
1. Entyvio™ (vedolizumab). [Prescribing Information]. Takeda Pharmaceuticals America, Inc. Deerfield, IL. March 2020.
2. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21.
3. Sands BE, Feagan BG, Rutgeerts P, et al. Effects of Vedolizumab Induction Therapy for Patients With Crohn's Disease in Whom Tumor Necrosis Factor Antagonist Treatment Had Failed. Gastroenterology. 2014 May 21. pii: S0016-5085(14)00656-8. doi: 10.1053/j.gastro.2014.05.008. [Epub ahead of print]
4. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710.
5. Feagan B, Sands B, Sankoh S, Milch C, Fox I. Efficacy of vedolizumab in ulcerative colitis by prior treatment failure in GEMINI I, a randomized, placebo-controlled, double-blind, multicenter trial [O-1b abstract]. Inflamm Bowel Dis. 2012;18(Suppl 1): S1-S127.
6. Micromedex® 2.0 (mobileMicromedex®). Vedolizumab. Truven Health Analytics Inc 2014. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/6A81EE/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/4E4CE4/ND_PG/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.DisplayDrugpointDocument?docId=930961&contentSetId=100&title=Vedolizumab&servicesTitle=Vedolizumab&topicId=dosingAndIndicationsSection&subtopicId=fdaSection. April 20,2015.
7. Gold Standard, Inc. Vedolizumab. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed: April 20,2015
8. Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009;104(2):465.
9. 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.
10. National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium - Vedolizumab. Available at: https://www.nccn.org/professionals/drug_compendium/content/default.aspx?AID=383 Accessed on May 1, 2019.
11. ClinicalTrials.gov. Entyvio. Available at https://clinicaltrials.gov/ct2/results?cond=&term=entyvio&cntry=&state=&city=&dist= Accessed May 1 2019.
12. NCCN Clinical Practice Guidelines in Oncology. Management of Immunotherapy-Related Toxicities. Version 2.2019. April 2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/immunotherapy.pdf. Accessed October 2019.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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