Vedolizumab (Entyvio)

Policy ID: I-9129-001

Section: Injections

Effective Date: May 01, 2021

Last Reviewed: March 17, 2021

Description

Vedolizumab (Entyvio) is a monoclonal antibody and integrin receptor antagonist used for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC) in adults. Vedolizumab (Entyvio) reduces chronically inflamed gastrointestinal tissue associated with UC/CD by binding to the α4β7 integrin receptor and inhibiting its interaction with mucosal addres sin cell adhesion molecule-1 (MAdCAM-1).

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Vedolizumab (Entyvio) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following:

Crohn’s Disease (CD)

The individual has a diagnosis of moderately to severely active CD; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with vedolizumab (Entyvio) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with vedolizumab (Entyvio) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- BOTH of the following:
  - ONE of the following:
    - The individual is eighteen (18) years of age or older; or
    - The prescriber has provided information in support of using vedolizumab (Entyvio) for the individual’s age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months; or
    - The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD; or
    - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD; or
    - The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use 1 or 2a for the treatment of CD; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
The individual will NOT be using vedolizumab (Entyvio) with another biologic immunomodulator agent or Otezla; and
The individual does NOT have any FDA labeled contraindications to vedolizumab (Entyvio).

Ulcerative Colitis (UC)

The individual has a diagnosis of moderately to severely active UC; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with vedolizumab (Entyvio) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with vedolizumab (Entyvio) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- BOTH of the following:
  - ONE of the following:
    - The individual is eighteen (18) years of age or older; or
    - The prescriber has provided information in support of using vedolizumab (Entyvio) for the individual’s age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3-months; or
    - The individual has severely active ulcerative colitis; or
    - The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC; or
    - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC; or
    - The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use 1 or 2a for the treatment of UC; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
The individual will NOT be using vedolizumab (Entyvio) with another biologic immunomodulator agent or Otezla; and
The individual does NOT have any FDA labeled contraindications to vedolizumab (Entyvio).

Vedolizumab (Entyvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

J3380

Reauthorization Criteria

Continuation of therapy with vedolizumab (Entyvio) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for vedolizumab (Entyvio) through the Blue Cross Blue Shield of North Dakota’s precertification process; and
The individual has had clinical benefit with vedolizumab (Entyvio); and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist for PsA, RA; gastroenterologist for CD, UC; dermatologist for PS) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual will NOT be using vedolizumab (Entyvio) with another biologic immunomodulator agent or Otezla; and
The individual does NOT have any FDA labeled contraindications to vedolizumab (Entyvio).

Procedure Codes

J3380

Vedolizumab (Entyvio) is considered not medically necessary for an individual with ANY of the following:

In combination with natalizumab (Tysabri); or
Uncontrolled active, severe infections including but not limited to: sepsis, tuberculosis, cytomegaloviral colitis, giardiasis, listeria meningitis, salmonella sepsis, anal abscess etc.; or
Individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC) recommended equivalent to evaluate for latent tuberculosis prior to initiating vedolizumab; or
New or worsening neurological signs or symptoms of John Cunningham virus (JCV) infection or risk of progressive multifocal leukoencephalopathy (PML).

Procedure Codes

J3380

Diagnosis Codes

K50.00	K50.011	K50.012	K50.013	K50.014	K50.018	K50.019
K50.10	K50.111	K50.112	K50.113	K50.114	K50.118	K50.119
K50.80	K50.811	K50.812	K50.813	K50.814	K50.818	K50.819
K50.90	K50.911	K50.912	K50.913	K50.914	K50.918	K50.919
K51.00	K51.011	K51.012	K51.013	K51.014	K51.018	K51.019
K51.20	K51.211	K51.212	K51.213	K51.214	K51.218	K51.219
K51.30	K51.311	K51.312	K51.313	K51.314	K51.318	K51.319
K51.40	K51.411	K51.412	K51.413	K51.414	K51.418	K51.419
K51.50	K51.511	K51.512	K51.513	K51.514	K51.518	K51.519
K51.80	K51.811	K51.812	K51.813	K51.814	K51.818	K51.819
K51.90	K51.911	K51.912	K51.913	K51.914	K51.918	K51.919

Professional Statements and Societal Positions Guidelines

FDA Labeled Contraindication(s)

Individuals who have had a known serious or severe hypersensitivity reaction to Entyvio or any of its excipients

ND Committee Review

Internal Medical Policy Committee 3-17-2021 Adopt policy, was previously policy number I-129

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-129-010

Section: Injections

Effective Date: June 01, 2020

Revised Date: May 13, 2020

Last Reviewed: March 17, 2021

Archived Date: April 30, 2021

Retiring for ND Effective: April 30, 2021

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Vedolizumab (Entyvio) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following indications:

Crohn’s Disease (CD):

- The individual is 18 years of age or older with moderately to severely active CD; and
- Any ONE of the following:
  - The individual is currently pregnant; or
  - Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
  - The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
  - The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, aminosalicylates, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], mesalamine, methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months or
  - The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD or
  - The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of CD; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for CD, UC) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using vedolizumab (Entyvio) with another biologic immunomodulator agent.

Ulcerative Colitis (UC):

- The individual is 18 years of age or older with moderately to severely active UC; and
- Any ONE of the following:
  - The individual is currently pregnant
  - Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
  - The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
  - The individual has tried and 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
  - The individual 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
  - The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of UC; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for CD, UC) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using vedolizumab (Entyvio) with another biologic immunomodulator agent.

Procedure Codes

J3380

Reauthorization Criteria

Continuation of therapy with vedolizumab (Entyvio) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for vedolizumab (Entyvio) through Blue Cross Blue Shield of North Dakota's precertification process; and
The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy; and
The individual will NOT be using the requested agent with another biologic immunomodulator agent.

Procedure Codes

J3380

Vedolizumab (Entyvio) is considered not medically necessary for an individual with ANY of the following:

In combination with natalizumab (Tysabri); or
Uncontrolled active, severe infections including but not limited to: sepsis, tuberculosis, cytomegaloviral colitis, giardiasis, listeria meningitis, salmonella sepsis, anal abscess etc.; or
Individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC) recommended equivalent to evaluate for latent tuberculosis prior to initiating vedolizumab; or
New or worsening neurological signs or symptoms of John Cunningham virus (JCV) infection or risk of progressive multifocal leukoencephalopathy (PML).

Procedure Codes

J3380

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

K50.00	K50.011	K50.012	K50.013	K50.014	K50.018	K50.019
K50.10	K50.111	K50.112	K50.113	K50.114	K50.118	K50.119
K50.80	K50.811	K50.812	K50.813	K50.814	K50.818	K50.819
K50.90	K50.911	K50.912	K50.913	K50.914	K50.918	K50.919
K51.00	K51.011	K51.012	K51.013	K51.014	K51.018	K51.019
K51.20	K51.211	K51.212	K51.213	K51.214	K51.218	K51.219
K51.30	K51.311	K51.312	K51.313	K51.314	K51.318	K51.319
K51.40	K51.411	K51.412	K51.413	K51.414	K51.418	K51.419
K51.50	K51.511	K51.512	K51.513	K51.514	K51.518	K51.519
K51.80	K51.811	K51.812	K51.813	K51.814	K51.818	K51.819
K51.90	K51.911	K51.912	K51.913	K51.914	K51.918	K51.919

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date July 1, 2018

Internal Medical Policy Committee 3-16-2020 Updated criteria to match other biologic immunomodulator criteria, update preferred products for UC, added reauthorization criteria

Internal Medical Policy Committee 5-19-2020 Removed preferred product language

Internal Medical Policy Committee 3-17-2021 Retiring for ND, policy being replaced by policy I-9129.

Links

References (PDF)

Disclaimer

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