Vedolizumab (Entyvio®)

Restricted Product(s):

• vedolizumab (Entyvio®) intravenous infusion for administration by a healthcare professional

FDA Approved Use:

• For the treatment of adults with moderately to severely active Crohn’s disease 
• For the treatment of adults with moderately to severely active ulcerative colitis

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient has a diagnosis of moderately to severely active Crohn’s disease (CD); AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least 3-months [medical record documentation required]; OR 
   3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD [medical record documentation required]; OR 
   4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD [medical record documentation required]; OR 
2. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC); AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least 3-months [medical record documentation required]; OR 
   3. The patient has severely active ulcerative colitis [medical record documentation required]; OR 
   4. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC [medical record documentation required]; OR 
   5. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC [medical record documentation required]; AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist for CD, UC) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
4. The patient will NOT be using vedolizumab (Entyvio®) in combination with another biologic immunomodulator agent or Zeposia®; AND 
5. The patient does NOT have any FDA labeled contraindications to vedolizumab (Entyvio®); AND 
6. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND 
7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
8. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)* 

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met: 
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
   5. Requirement of a change in the requested restricted product formulation; AND 
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References:

all information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

September 2023: Criteria change: For Crohn’s disease: Removed aminosalicylates, mesalamine, and sulfasalazine from list of conventional agents. For ulcerative colitis: Updated policy to allow bypassing conventional agents for severely active ulcerative colitis; removed steroid suppositories from list of conventional agents. Separated out intolerance/hypersensitivity criteria from FDA labeled contraindication criteria for clarity. Added Zeposia as agent not to be used in combination with another biologic immunomodulator agent for clarity. Updated FDA label reference table for clarity according to FDA label.
October 2021: Criteria change: Added quantity limit exception criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.
August 2021: Criteria change: Removed criteria points regarding medication history indicating use of another biologic immunomodulator agent FDA labeled for the treatment of the same condition. Policy notification given 6/1/2021 for effective date 8/1/2021.
June 2021: Criteria change: Medical record documentation required for all indications.
April 2021: Criteria change: Addition of criteria for history of use of another biologic immunomodulator agent for the same indication; added requirement to be prescribed by or in consultation with a specialist; added requirements that the patient will not be using the requested agent in combination with another biologic immunomodulator agent, patient has no FDA labeled contraindications, and for TB testing; added maximum units; medical policy formatting change. Policy notification given 2/26/2021 for effective date 4/28/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.