Product Details

Mekinist

Trametinib
2 mg
Tablet


DIN/PIN/NPN

02409658

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2023-04-28  

Unit Price

325.6493

Amount MOH Pays

325.6493

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EE01

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Trametinib

  • Brand(s): Mekinist
  • Dosage Form/Strength: 0.5 mg, 2 mg tablet
  • Updated January 7, 2020

Initial criteria:

For the mutation-targeted treatment of patients with BRAF V600 mutation-positive unresectable melanoma or metastatic melanoma meeting the following criteria:

  1. As monotherapy or as combination therapy with dabrafenib.

  2. If brain metastases are present, they should be asymptomatic or stable

Exclusion Criteria:

  • BRAF V600 negative, or wild type tumors, or unknown status will not be funded

  • Funding will not be considered in patients who have experienced progression on a BRAF mutation targeted therapy. The Ministry will fund only one BRAF mutation targeted treatment/treatment regimen.

  • May be sequenced after immunotherapies or other funded treatments, however, treatment beyond third line will not be considered for funding.

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:

  • BRAF V600 negative, or wild type tumors, or unknown status will not be funded

  • Trametinib therapy (as monotherapy or in combination with dabrafenib) will not be considered for funding in patients who have progressed on a prior BRAF inhibitor therapy used as monotherapy or in combination.

For the adjuvant treatment of resected Stage III cutaneous melanoma in patients meeting ALL the following criteria:

  1. Trametinib is being used as combination therapy with Dabrafenib

  1. Patient’s cutaneous melanoma met the following requirements prior to resection:
    a) Histologically confirmed stage IIIA (limited to lymph node metastases of > 1 mm), IIIB, IIIC, or IIID cutaneous melanoma [8th edition of the American Joint Committee on Cancer staging system]
    b) BRAF V600 mutated (all BRAF V600 mutations)

  1. Post-resection, clinical or radiographic confirmation of complete disease resection including absence of in-transit metastases must be provided.1

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2

1Micrometastatic lymph node involvement detected by sentinel lymph node biopsy will be allowed.

Exclusion Criteria:

  • Patients with stage IIIA cutaneous melanoma with lymph node metastases less than 1 mm. 

  • Monotherapy with Dabrafenib 

  • Combinations with other anticancer therapies

Recommended Dose in adjuvant therapy:
Trametinib 2mg once daily and Dabrabenib 150 mg twice daily

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:

  1. The Ministry will reimburse for provincially funded treatments for use in the adjuvant setting in patients with cutaneous melanoma for a total duration of up to 12 months. Overall access to adjuvant therapy will be limited to 12 months in total and combines the duration of use of all treatments administered in the adjuvant setting.

  1. Funding will not be granted for dabrafenib-trametinib in patients who have used another treatment in the adjuvant setting for cutaneous melanoma for a duration of 3 months or longer.

  1. A one-time switch to dabrafenib-trametinib in the adjuvant cutaneous melanoma setting will be permitted for BRAF-mutated patients who switch from another adjuvant treatment that has been used for less than 3 months and upon meeting the above funding criteria.

  1. Patients who experience disease progression within 6 months of completion of adjuvant BRAF therapy will not be funded for another BRAF targeted therapy.

  1. Switching to cobimetinib-vemurafenib from dabrafenib-trametinib will not be permitted in BRAF-positive patients.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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