Product Details
Mekinist
Trametinib0.5 mg
Tablet
DIN/PIN/NPN
02409623
Manufacturer
Novartis Pharma Canada Inc.
Formulary Listing Date
2023-04-28
Unit Price
81.7520
Amount MOH Pays
81.7520
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L01EE01
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Oncology Drugs | Trametinib
Initial criteria: For the mutation-targeted treatment of patients with BRAF V600 mutation-positive unresectable melanoma or metastatic melanoma meeting the following criteria:
Exclusion Criteria:
Recommended Dose as Monotherapy: 2 mg once daily until disease progression or development of unacceptable toxicity requiring discontinuation of trametinib Recommended Dose as combination dual therapy with Dabrafenib: Trametinib 2mg once daily and Dabrabenib 150 mg twice daily, until disease progression or development of unacceptable toxicity requiring discontinuation Renewal criteria: Therapy as monotherapy OR as combination dual therapy (as above) may be continued until evidence of disease progression1 or development of unacceptable toxicity requiring discontinuation. 1Letter from physician outlining radiological and clinical benefit requiring continuation of the drug and verification of no disease progression must be submitted. Approval duration (both initial and renewal requests): 6 months (patients should have their disease status assessed at least every 6 months) Case by case: Requests in patients who have initiated another single-agent BRAF or MEK inhibitor therapy will be considered on a case-by-case basis ONLY IF there has been no disease progression. Requests in patients who have initiated another single-agent BRAF or MEK inhibitor therapy will be considered on a case-by-case basis ONLY IF there has been no disease progression. Exclusion Criteria:
For the adjuvant treatment of resected Stage III cutaneous melanoma in patients meeting ALL the following criteria:
1Micrometastatic lymph node involvement detected by sentinel lymph node biopsy will be allowed. Exclusion Criteria:
Recommended Dose in adjuvant therapy: Notes: Treatment administered post-resection until disease recurrence or unacceptable toxicity to a maximum of 12 months of treatment in total. (Note: 12 months refers to duration of adjuvant treatment accessed through all sources of funding (i.e., private and public). Approval duration: Maximum of 12 months. Renewals are not considered. Additional notes:
EAP Drug Request Form: |