Product Details

Entyvio

Vedolizumab
300 mg/Vial
Powder for Concentrate for Solution for Infusion
Single-Use 20-mL Vial (Preservative-Free)

DIN/PIN/NPN

02436841

Manufacturer

Takeda Canada Inc.

Formulary Listing Date

2023-04-28  

Unit Price

3401.8600

Amount MOH Pays

3401.8600

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA33

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Inflammatory Bowel Diseases

Vedolizumab

  • Brand(s): Entyvio
  • Dosage Form/Strength: 300 mg Injection, 108 mg/0.68mL prefilled syringe and prefilled pen
  • Updated: October 18, 2022

Vedolizumab for Fistulising Crohn’s disease with concomitant luminal disease

For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet ALL the following criteria:

  1. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of
    •     appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g. azathioprine or 6-mercaptopurine)
    OR
    • appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and adalimumab or infliximab with or without an immunosuppressive therapy

    AND

  2. Harvey Bradshaw Index (HBI) score greater than or the same as 7 (or other validated disease activity score confirming moderate to severe disease)

Initial approved dose: 300 mg initially Intravenously (IV) administered at week 0, followed by 300mg at week 2, 300mg at week 6, then 300 mg every 8 weeks thereafter. 

Note: Entyvio subcutaneous (SC) doses is to be used as a maintenance treatment, following at least two intravenous infusions, 108 mg administered by subcutaneous injection once every 2 weeks, with the first subcutaneous dose administered in place of the next scheduled intravenous dose and every 2 weeks thereafter. 

Doses exceeding the standard recommended doses will be considered on a case-by-case basis. Please provide clinical rationale to support the request for higher doses.

Renewal Criteria:

Maintenance therapy is funded for patients who met the initiation criteria and who achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Please include information describing the patient’s fistula(e) resolution (e.g., partial or complete resolution) and HBI score.

Approved Renewal/Maintenance dose: 300 mg every eight weeks or 108 mg SC every 2 weeks

Exclusion criteria (for Initials and Renewals):

  • Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.

Approval durations:
- Initial approval: 6 months
- First renewal: 6 months to 1 year pending fistula(e) resolution
- Second and subsequent renewals: 2 years with complete resolution

The duration of approval for patients with partial resolution will be provided on a case-by-case basis.

Vedolizumab for Luminal Crohn’s disease 

Initial Criteria: 

For the treatment of moderate to severe luminal Crohn's disease in patients who meet ALL of the following criteria:

  1. Has a Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn’s disease); AND 

  1. Has failed conventional treatment with a corticosteroid (prednisone 40–60 mg/day [or equivalent]) for a minimum of 14 days (or an intravenous corticosteroid for 1 week);
    OR
    Has responded to or has stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate);
    OR
    Has a contraindication to corticosteroids which prevents the use of initial conventional treatment with corticosteroids;

    AND

  2. Vedolizumab is being used to induce remission or as a steroid-sparing maintenance therapy.

Notes: Patients with mild Crohn’s disease (e.g., HBI less than 7) may be considered on a case-by-case basis but the application must include the rationale for coverage and other relevant details.

Initial approved dose: 300 mg initially Intravenously (IV) administered at week 0, followed by 300mg at week 2, 300mg at week 6, then 300 mg every 8 weeks thereafter.

Note: Entyvio subcutaneous (SC) doses is to be used as a maintenance treatment, following at least two intravenous infusions, 108 mg administered by subcutaneous injection once every 2 weeks, with the first subcutaneous dose administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.

Doses exceeding the standard recommended doses will be considered on a case-by-case basis. Please provide clinical rationale to support the request for higher doses. 

Renewal Criteria: 

Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.

Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.

Approved Renewal/Maintenance doses: 300mg IV every 8 weeks or 108 mg SC every 2 weeks.

Note: Entyvio subcutaneous (SC) doses is to be used as a maintenance treatment, following at least two intravenous infusions, 108 mg administered by subcutaneous injection once every 2 weeks, with the first subcutaneous dose administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.

Doses exceeding the standard recommended doses will be considered on a case-by-case basis. Please provide clinical rationale to support the request for higher doses.

Exclusion criteria (for Initials and Renewals):

  • Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.

Approval Durations:
- Initial approval: 6 months
- First EAP renewal: 1 year
- Second and subsequent EAP renewals: 2 years

Vedolizumab for Ulcerative Colitis

For the treatment of moderate to severe ulcerative colitis in patients who meet ALL the following criteria:

  1. Has a Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND 

  1. Has failed conventional treatment with a corticosteroid (prednisone 40–60 mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
    OR
    Has responded to or has been stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6- mercaptopurine);
    OR
    Has a contraindication to corticosteroids which prevents the use of initial conventional treatment with corticosteroids;

    AND

  2. Vedolizumab is being used to induce remission or as a steroid-sparing maintenance therapy.

*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.

Notes: Patients with mild ulcerative colitis disease (e.g., Mayo score less than 6) may be considered on a case-by-case basis. Application must include the rationale for coverage and other relevant details.

Initial approved dose: 300 mg initially Intravenously (IV) administered at week 0, followed by 300mg at week 2, 300mg at week 6, then 300 mg every 8 weeks thereafter.

Note: Entyvio subcutaneous (SC) doses is to be used as a maintenance treatment, following at least two intravenous infusions, 108 mg administered by subcutaneous injection once every 2 weeks, with the first subcutaneous dose administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.

Doses exceeding the standard recommended doses will be considered on a case-by-case basis. Please provide clinical rationale to support the request for higher doses.

Renewal Criteria:

Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction of corticosteroid doses by 50% in the first 6 months of treatment with vedolizumab with discontinuation of corticosteroids by 12 months. Patients who remain on corticosteroids following the first year of treatment will be considered on a case-by-case basis.

Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. 

Approved Renewal/Maintenance dose: 300 mg every eight weeks or 108 mg SC every 2 weeks

Exclusion criteria (for Initials and Renewals):

  • Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.

Approval durations:
- Initial approval: 6 months
- First renewal: 6 months to 1 year depending on whether the patient is able to reduce and/or discontinue corticosteroid treatment
- Second and subsequent renewals: 2 years with complete discontinuation of corticosteroid treatment

EAP Drug Request Form:

Standard Form for EAP Drug Requests

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