Product Details

Tukysa

Tucatinib
50 mg
Tablet


DIN/PIN/NPN

02499827

Manufacturer

Seagen Canada Inc.

Formulary Listing Date

2023-02-21  

Unit Price

60.1700

Amount MOH Pays

60.1700

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EH03

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Tucatinib

  • Brand(s): Tukysa
  • Dosage Form/Strength: 50 mg, 150 mg tablet
  • Effective date: February 21, 2023

Initial criteria:

For the treatment of adult patients with HER-2 positive locally advanced or metastatic breast cancer in patients meeting ALL the following criteria:

  1. Patient is at least 18 years old; AND

  1. HER2-positive status is confirmed using a validated test; AND

  1. Has received at least ONE prior systemic treatment for HER-2 positive locally advanced/metastatic breast cancer; AND

  1. Has received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine (TDM-1) separately or in combination; AND

  1. Has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 and have adequate blood counts and organ function; AND

  1. Tucatinib is not being used as monotherapy and must be used in combination with trastuzumab and/or capecitabine unless the patient must discontinue for therapeutic reasons either trastuzumab or capecitabine, but not both. (see note 1).

Exclusion criteria:

Patients who have experienced disease progression on capecitabine used in a prior line of therapy.

Notes:

  1. Treatment with tucatinib can continue if discontinuation is required for either capecitabine or trastuzumab due to toxicity. If trastuzumab and capecitabine are both discontinued, tucatinib must also be discontinued as it is not funded as monotherapy.

  1. Patients with brain metastases are eligible for funding of tucatinib upon meeting all the criteria.

  1. Patients currently or previously treated with lapatinib can be considered for tucatinib-capecitabine-trastuzumab combination therapy as long as the lapatinib therapy is stopped.

  1. Patients currently on capecitabine monotherapy may add tucatinib and trastuzumab to the treatment regimen as long as disease progression on capecitabine has not occurred.

  1. Patients who have not experienced disease progression on their current systemic therapy may consider switching to a tucatinib-trastuzumab-capecitabine regimen if the tucatinib criteria are otherwise met. 

  1. Prior treatment with trastuzumab deruxtecan as an alternative to trastuzumab emtansine (T-DM1) will be considered on case-by-case basis. (Please refer to Ontario Health – Cancer Care Ontario for policies for the funding of trastuzumab within this regimen.)

Renewal Criteria:
Renewals will be considered in patients who have not demonstrated evidence of disease progression or development of unacceptable toxicity requiring discontinuation of tucatinib or discontinuation of both capecitabine and trastuzumab (see Note 1)

Recommended dose:
Tucatinib 300 mg orally twice daily 

Tucatinib is funded in combination with capecitabine and trastuzumab at the recommended doses as follows: 

Capecitabine 1000 mg/m2 orally twice daily on days 1 to 14 of every 21-day cycle. 

Trastuzumab 8 mg/kg as a loading dose intravenously (IV) on day 1 of the first cycle, followed by 6 mg/kg IV every 21 days until disease progression or unacceptable toxicity, whichever comes first. (Note: Other dosing options may be administered. Please refer to Ontario Health Cancer Care Ontario)

Approval Duration (Initials): 6 months

Approval Duration of first renewal: 6 months

Approval Duration of renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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