Product Details

Lonsurf

Trifluridine + Tipiracil
20 mg + 8.19 mg
Tablet


DIN/PIN/NPN

02472112

Manufacturer

Taiho Pharma Canada, Inc.

Formulary Listing Date

2021-03-25  

Unit Price

78.5385

Amount MOH Pays

78.5385

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01BC59

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Trifluridine/Tipiracil

  • Brand(s): Lonsurf
  • Dosage Form/Strength: 15 mg/6.14mg tablet, 20 mg/8.19mg tablet
  • Effective date: March 25, 2021

Initial Criteria:

In combination with best supportive care (BSC) for the treatment of metastatic gastric cancer (mGC) or adenocarcinoma of the gastroesophageal junction (GEJ) in adult patients who meet ALL of the following criteria:

  1. Patient has histologically confirmed non-resectable, metastatic, gastric adenocarcinoma (including GEJ) as defined by the American Joint Committee of Cancer (AJCC) staging classification; AND 

  1. Patient has experienced disease progression1 and/or clinically relevant intolerances or allergies with at least two (2) prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan-containing regimen;
    OR
    Patient has HER2 positive disease and has experienced disease progression1 and/or clinically relevant intolerances or allergies with at least two (2) prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan-containing regimen, and at least one HER2/neu-targeted therapy;

    AND

  2. Patient has Eastern Cooperative Oncology Group (ECOG) status 0 or 1.

1As confirmed via imaging during/within 3 months of previously completed line(s) of therapy

Note: If patients have experienced intolerances with the prior lines of therapy, please provide a description of the intolerance including grade of toxicity which required the drug regimen to be stopped.

Renewal Criteria:
Renewals will be considered until radiographic evidence of disease progression or development of unacceptable toxicities.

Renewals should include radiographic reports and will be evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1 criteria.

Approval duration of initial and renewals: 6 months.

Recommended dose:
35 mg/m2/dose twice daily on days 1 to 5 and days 8 to 12 of each 28-day cycle.
Dose adjustments based on individual safety and tolerability.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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