Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Vedolizumab (Entyvio®)
Policy #:MA08.001c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.

MEDICALLY NECESSARY

Vedolizumab (Entyvio®) is considered medically necessary and, therefore, covered for any of the following indications:

ULCERATIVE COLITIS (UC)
  • In adult individuals with moderately to severely active UC who meet all of the following criteria:
    • Inadequate response, lost response, or intolerance to a 3-month trial of a tumor necrosis factor (TNF) blocker (e.g., adalimumab Humira®) or immunomodulator (e.g., azathioprine, 6-mercaptopurine), or inadequate response to, intolerance of, or demonstrated dependence on, corticosteroids
    • Vedolizumab (Entyvio®) is dosed at 300mg I.V. infusion at 0, 2, and 6 weeks, and then every 8 weeks thereafter. The FDA labeling indicates that therapy be discontinued in individuals who show no evidence of therapeutic benefit by Week 14.

CROHN'S DISEASE (CD)
  • In adult individuals with moderately to severely active CD who meet all of the follow criteria:
    • Inadequate response with, lost response to, or were intolerant of, a 3-month trial of a tumor necrosis factor (TNF) blocker (e.g., adalimumab Humira®) or immunomodulator (e.g., azathioprine, 6-mercaptopurine, methotrexate), or had an inadequate response with, were intolerant to, or demonstrated dependence on, corticosteroids
    • Vedolizumab (Entyvio®) is dosed at 300mg I.V. infusion at 0, 2, and 6 weeks, and then every 8 weeks thereafter. The FDA labeling indicates that therapy be discontinued in individuals who show no evidence of therapeutic benefit by Week 14.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for vedolizumab (Entyvio®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

DOSING AND FREQUENCY REQUIREMENTS

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of vedolizumab (Entyvio®). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of vedolizumab (Entyvio®) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of (for single drugs in a policy, state “this drug”) these drugs. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for vedolizumab (Entyvio®).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

When coverage of vedolizumab (Entyvio®) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.
Policy Guidelines

There is no Medicare coverage determination addressing this drug; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, vedolizumab (Entyvio®) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria and Dosing and Frequency Requirements listed in this medical policy are met.

For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when vedolizumab (Entyvio®) is covered under a member's medical benefit (Part B benefit). It does not address instances when vedolizumab (Entyvio®) is covered under a member’s pharmacy benefit (Part D benefit).

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Vedolizumab (Entyvio®) was approved by the FDA on May 2014 for moderately to severely active ulcerative colitis and Crohn's disease.

PEDIATRIC USE

The safety and effectiveness of vedolizumab (Entyvio®) have not been established in the pediatric population.

Description

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract of unknown etiology. IBD has two major categories: ulcerative colitis (UC) and Crohn's disease (CD). The most common symptoms in UC and CD are diarrhea, rectal bleeding, urgency to have bowel movements, abdominal cramps, pain, fever, and weight loss. Even though UC and CD have similar clinical presentations, they differ in the body areas affected. UC primarily causes inflammation of the mucosal lining and is generally limited to the colon and rectum, whereas CD affects the entire digestive system and can produce ulcers that extend deep into the intestinal wall.

On May 20, 2014, the US Food and Drug Administration (FDA) approved vedolizumab (Entyvio®) for moderately to severely active UC and moderately to severely active CD. Vedolizumab (Entyvio®) is indicated for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving the endoscopic appearance of the mucosa, and achieving corticosteroid-free remission in adult individuals with moderately to severely active ulcerative colitis. Vedolizumab (Entyvio®) is also indicated for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission in adult individuals with moderately to severely active CD.

Vedolizumab (Entyvio®) is a humanized monoclonal antibody that binds to a specific integrin protein found on white blood cells and prevents the integrin's ability to bind with a cell adhesion molecule found on gastrointestinal blood vessels. This inhibition prevents the memory T-cells from migrating into inflamed gastrointestinal parenchymal tissue and helps to minimize the chronic inflammation, which is a hallmark symptom of UC and CD.

The effectiveness of vedolizumab (Entyvio®) for active UC was evaluated using two integrated randomized, double-blind, placebo-controlled trials. For the induction therapy trial, 374 individuals randomly received vedolizumab (Entyvio®) or placebo intravenously at weeks 0 and 2. Clinical response was assessed using the Mayo Clinic score. For the maintenance therapy trial, at week 6, the individuals who had a clinical response to vedolizumab (Entyvio®) were randomly assigned to one of three therapies: to continue vedolizumab (Entyvio®) treatment every 4 weeks, continue vedolizumab (Entyvio®) treatment every 8 weeks, or to switch to a placebo for up to 52 weeks. The response rate at the end of the induction therapy trial (week 6) was 47.1% for vedolizumab (Entyvio®) group versus 25.5% for the placebo-controlled group. At the conclusion of the maintenance therapy trial (week 52), clinical remission was reached in 41.8% of individuals who received vedolizumab (Entyvio®) every 8 weeks and 44.8% of individuals who received vedolizumab (Entyvio®) every 4 weeks compared to 15.9% of the placebo-controlled group.

For active CD the effectiveness of vedolizumab (Entyvio®) was evaluated using two integrated randomized, parallel-group, double-blind, placebo-controlled studies. In the trial of induction therapy, 368 individuals randomly received vedolizumab (Entyvio®) or placebo at weeks 0 and 2. Clinical response to the therapy was determined using the Crohn's Disease Activity Index. The maintenance therapy trial was composed of individuals who had a clinical response to vedolizumab (Entyvio®) in the double-blind group, and individuals who had a clinical response in the open-label parallel-group. From these two groups, 461 therapy-responsive individuals were randomly assigned to continue vedolizumab (Entyvio®) treatment every 4 weeks, to continue vedolizumab (Entyvio®) treatment every 8 weeks, or to switch to a placebo for up to 52 weeks. At week 6, 31.4% of the vedolizumab (Entyvio®) group had a clinical response to therapy compared to 25.7% in the placebo-controlled group. In the vedolizumab (Entyvio®) group, 14.5% were in clinical remission at week 6 versus 6.8% in clinical remission in the placebo-controlled group. At the end of week 52, clinical remission was reached in 39.0% of individuals who received vedolizumab (Entyvio®) every 8 weeks and in 36.4% of individuals who received vedolizumab (Entyvio®) every 4 weeks compared to 21.6% of the placebo-controlled group.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

AGA Institute Guidelines for the Identification, Assessment and Initial Medical Treatment in Crohn’s Disease. Available at: http://campaigns.gastro.org/algorithms/IBDCarePathway/ . Accessed October 9, 2019.

AGA Institute Guidelines for the Identification, Assessment and Initial Medical Treatment in Ulcerative Colitis. Clinical Care Pathway. 2019. Available at: https://www.gastrojournal.org/article/S0016-5085(18)35407-6/pdf. Accessed October 9, 2019.

American Hospital Formulary Service (AHFS). Drug Information 2017. Vedolizumab. [Lexicomp Online Web site]. 02/22/2019. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed October 9, 2019.

Bhavik M and Bloomfield R. Inflammatory Bowel Disease. American College of Gastroenterology. 2017. Available at: http://patients.gi.org/topics/irritable-bowel-syndrome/#tabs2. Accessed October 9, 2019.

Centers for Disease Control and Prevention. Inflammatory Bowel Disease. [Centers for Disease Control and Prevention]. Available at: http://www.cdc.gov/ibd/. 03/14/2017. Accessed October 9, 2019.

Elsevier’s Gold Standard Clinical Pharmacology Compendium. Vedolizumab. [Clinical Pharmacology Web site]. 03/16/2018. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed October 9, 2019.

Entyvio® (Vedolizumab) [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; 05/2019. Available online at:http://general.takedapharm.com/content/file.aspx?filetypecode=ENTYVIOPI&CountryCode=US&LanguageCode=EN&cacheRandomizer=0f90ea19-c701-42b8-a181-620a77edea92. Accessed October 9, 2019.

Feagan BG, Patel H, Colombel JF, et al. Effects of vedolizumab on health-related quality of life in patients with ulcerative colitis: results from the randomised GEMINI 1 trial. Aliment Pharmacol Ther. 2017;45(2):264-275.

Feagan B, Rutgeerts P, Sands B, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. New Engl J Med. 2013;369(8):699-710.

Hahn L, Briggs A, Wahaib K, etc. Vedolizumab: An integrin-receptor antagonist for treatment of Crohn's disease and ulcerative colitis. Am J Health Syst Pharm. 2015;72:1271-8.

Lexi-Drugs Compendium. Vedolizumab. [Lexicomp Online Web site]. 02/22/2019. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/5161002 [via subscription only]. Accessed October 9, 2019.

Loftus EV Jr, Colombel JF, Feagan BG, et al. Long-term efficacy of vedolizumab for ulcerative colitis. J Crohns Colitis. 2016. pii: jjw177. 04/2017.

Parikh A, Fox I, Leach T, et al. Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2013;19(8):1691-9.

Parikh A, Leach T, Wyant T, et al. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis. 2012;18(8):1470-9.

Sandborn WJ. Crohn's Disease Evaluation and Treatment: Clinical Decision Tool. Gastroenterology 2014;147:702-705.

AGA Institute Guidelines for the Identification, Assessment and Initial Medical Treatment in Crohn’s Disease. Available at: http://campaigns.gastro.org/algorithms/IBDCarePathway/ . Accessed October 9, 2019.

Sandborn W, Feagan B, Rutgeert P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. New Engl J Med.2013;369(8):711-721.

Talley NJ, Abreu MT, Achkar JP, et al; American College of Gastroenterology IBD Task Force. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106 Suppl 1:S2-25; quiz S26. Available at: http://s3-patients.gi.org/files/2011/10/AJG-IBD-supplement-0411.pdf . Accessed October 9, 2019.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Vedolizumab. 05/10/2019. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/CS/3525B3/ND_PR/evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/06EBD4/ND_PG/evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/PFActionId/evidencexpert.GoToDashboard?docId=930961&contentSetId=100&title=Vedolizumab&servicesTitle=Vedolizumab&brandName=Entyvio# [via subscription only]. Accessed October 9, 2019.

US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. Vedolizumab (Entyvio®). Approval letter. [FDA Web site].05/07/2019. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125476Orig1s000ltr.pdfAccessed October 9, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Drug details: Vedolizumab (Entyvio). [FDA Web site]. 05/07/2019. Available at: http://www.accessdata.fda.gov/scripts/cder/daf/#apphist . Accessed October 9, 2019.

Vermeire S, Loftus EV Jr, Colombel JF, et al. Long-term efficacy of vedolizumab for Crohn's disease. J Crohns Colitis. 2017 Sep 28.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)



J3380 Injection, vedolizumab, 1 mg


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Vedolizumab (Entyvio®)
Description: ICD-10 CODES AND NARRATIVES






Policy History

Revisions from MA08.001c
12/30/2019This version of the policy will become effective 12/30/2019.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA).
Policy criteria for moderately to severely active ulcerative colitis UC and severely active Crohn's Disease CD were updated.
_____________________________________________
Note: On 01/07/2020 the medical criteria were updated in the Policy Section as follows:
Under Ulcerative Colitis, this statement was removed:
    "There is no step therapy at this time for this drug for MA. For individuals that have not previously received a biologic to treat adult moderately to severely active UC, vedolizumab (Entyvio®) is only eligible for coverage when the individual has a documented failure, contraindication, or intolerance to infliximab (Remicade®) or ustekinumab (Stelara®), or there is a clinical reason that a trial of infliximab (Remicade®) or ustekinumab (Stelara®) would be otherwise inappropriate for the member."

This medical criteria update is retroactively effective to 12/30/2019.


Revisions from MA08.001b
05/05/2017This policy has been updated to communicate the coverage of vedolizumab (Entyvio®) when dosing and frequency requirements are met.

The time-frame of a 3-month trial was added to the Policy criteria for a tumor necrosis factor (TNF) blocker or immunomodulator.


Revisions from MA08.001a
02/03/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Vedolizumab (Entyvio®).
01/01/2016This policy has been identified for the HCPCS code update, effective 01/01/2016.

The following HCPCS codes have been deleted from this policy: C9026, J3590

The following HCPCS code has been added to this policy: J3380

Revisions from MA08.001
03/18/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on vedolizumab (Entyvio®)
01/01/2015This is a new policy.






Version Effective Date: 12/30/2019
Version Issued Date: 12/30/2019
Version Reissued Date: N/A