Product Details

Revestive

Teduglutide
5 mg/Vial
Powder for Solution for Subcutaneous Injection
Single-Use 5-mg Vial Pack (Preservative-Free)

DIN/PIN/NPN

02445727

Manufacturer

Takeda Canada Inc.

Formulary Listing Date

2023-04-28  

Unit Price

925.0000

Amount MOH Pays

925.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

A16AX08

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Inflammatory Bowel Diseases

Teduglutide

  • Brand(s): Revestive
  • Dosage Form/Strength: 5 mg vials for Injection
  • Updated April 6, 2021

Applications for reimbursement should be accompanied by a copy of the parenteral support weekly usage volumes at baseline prior to start of teduglutide and must include the parenteral support usage volumes for the 4 weeks of use prior to the date that the Ministry funding for initial or renewal is requested.

Adults (age ≥ 18 years) - Initial Criteria:

For the ongoing funding of patients who have turned 18 years of age who were previously funded upon meeting EAP funding criteria and who continue to meet the adult renewal criteria;
OR
For the ongoing treatment of new patients requesting public funding who are at least 18 years of age with Short Bowel Syndrome (SBS) who meet the following criteria: 

Prior to starting teduglutide (Revestive), the patient meets the following:

  1. Has short bowel syndrome (SBS) as a result of major intestinal resection due to injury, volvulus, vascular disease, cancer, or Crohn’s Disease1; AND

  2. Patient’s intestinal resection has resulted in dependency on parenteral nutrition for at least 12 months; AND

  3. Patient requires parenteral nutrition required at least three times weekly to meet caloric, fluid or electrolyte needs due to ongoing malabsorption; AND

  4. Patient’s frequency and volume of parenteral nutrition has been stable for at least one month; 

Those who are initiated on teduglutide upon meeting the above criteria will be reimbursed for ongoing access of teduglutide through the Exceptional Access Program (EAP) upon meeting the below criteria:

  • The patient has achieved at least a 20% reduction in Parenteral Support volume while on teduglutide in the 4 weeks prior to the application for funding to EAP compared to their baseline measures in the 4 weeks prior to start of teduglutide.2,3 

1Case-by-case consideration will be provided for requests for patients with short bowel syndrome not due to the reasons provided. 

2Parenteral Support volumes measurements are to compare the 4 weeks of use prior to start of teduglutide with the 4 weeks of use prior to the date that EAP request for funding is provided. 

3For adult patients (i.e., at least 18 years of age) requesting EAP funding for ongoing teduglutide therapy who initiated on teduglutide between 1 and 17 years of age that was not publicly funded, ongoing response to teduglutide will be evaluated through comparing the patient’s current (i.e., while on teduglutide in the 4 weeks prior to the application for funding to EAP) Parenteral Support volume to the patient’s adjusted initial Parenteral Support volume.

For clarity, adjusted initial Parenteral Support volume is defined as the patient’s last available weight as a pediatric multiplied by the patient’s baseline Parenteral Support volume and divided by the patient’s baseline weight at initiation (i.e., in the 4 weeks prior to start of teduglutide as a pediatric) of teduglutide. 

Duration of approval: 12 months 

Exclusion Criteria:

  • Patients with active gastrointestinal malignancy or history of gastrointestinal malignancy in the past 5 years before start of treatment

Renewal Criteria:
Renewals will be considered in those who are able to demonstrate a reduction in their Parenteral Support volume requirements by at least 20% compared to baseline measures prior to commencing therapy with teduglutide.3
Applications for renewal of reimbursement should be accompanied by a copy of the Parenteral Support weekly usage volumes for the 4 weeks of use prior to the date that the Ministry funding is requested. 

Duration of approval: 12 months

Discontinuation/Stopping Criteria:
Patients will not be approved for funding by the EAP if a 20% reduction in the usual average weekly volume of Parenteral Support solutions prior to starting therapy with teduglutide has not been achieved/maintained by 52 weeks of treatment with teduglutide

Pediatrics (age between 1 and 17 years) - Initial Criteria:

For the ongoing treatment of patients between 1 and 17 years of age with Short Bowel Syndrome (SBS) who are dependent on Parenteral Support who meet the following criteria:

Prior to starting teduglutide (Revestive), the patient meets the following criteria:

  1. Has short bowel syndrome (SBS) as a result of major intestinal resection; AND 

  2. Parenteral Support requirements must be stable or there must have been no improvement in enteral feeding for at least the preceding three months; AND 

  3. The cumulative lifetime duration of Parenteral Support therapy must be at least 12 months; AND

  4. Patient requires parenteral support to provide more than 30% of caloric, and/or fluid/electrolyte needs due to ongoing malabsorption; AND

  5. Request is from a physician or nurse practitioner working within a specialized multi-disciplinary intestinal rehabilitation program. 

Those who are initiated on teduglutide upon meeting the above criteria will be reimbursed for ongoing access of teduglutide through the Exceptional Access Program (EAP) upon meeting the below criteria: 

  • Initial treatment response is assessed 6 months or more after initiating treatment with teduglutide. 

  • The patient has achieved at least a 20% reduction in weight-adjusted Parenteral Support volume while on teduglutide in the 4 weeks prior to the application of funding to EAP compared to their baseline weight-adjusted Parenteral Support volume measures in the 4 weeks prior to start of teduglutide.1,2 

1Weight-adjusted Parenteral Support volume is defined as the patient’s Parenteral Support volume divided by the Patient’s weight. 

2Parenteral Support volumes measurements are to compare the 4 weeks of use prior to start of teduglutide with the 4 weeks of use prior to the date that EAP request for funding is provided.

Notes:

  1. Parenteral Support volume and percentage of total consumption should be documented at each clinic visit.

  1. Assessments for subsequent renewals should be carried out at 6-month intervals.

Duration of first EAP approval: 7 months

Exclusion Criteria:

  • Patients with active gastrointestinal malignancy or history of gastrointestinal malignancy in the past 5 years before start of treatment 

Renewal Criteria:
Renewals will be considered in patients who are able to demonstrate a reduction in their weight-adjusted Parenteral Support volume requirements by at least 20% compared to baseline weight-adjusted Parenteral Support volume measures prior to commencing therapy with teduglutide.1
Applications for renewal of reimbursement should be accompanied by a copy of the weight-adjusted Parenteral Support weekly usage volumes for the 4 weeks of use prior to the date that the Ministry funding is requested. 

Duration of approval: 12 months 

Discontinuation/Stopping Criteria:
Patients meeting initial funding criteria will not be approved for ongoing funding by the EAP if a 20% reduction in the usual average weekly volume of weight-adjusted Parenteral Support solutions prior to starting therapy with teduglutide has not been achieved/maintained at the time of renewal.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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