Funded, December 1, 2016
BRAF V600 mutation-positive unresectable or metastatic melanoma. Previously untreated or as second–line treatment for patients previously treated with first line pembrolizumab or ipilimumab or nivolumab. Only one BRAF/MEK targeted treatment will be funded (Dabrafenib, trametinib or combination). ECOG 0–1. Adequate hematological, hepatic and renal function. If brain metastases are present, patients should be asymptomatic or stable. A BCCA “Compassionate Access Program” request with appropriate clinical information for each patient must be approved prior to treatment. 

Funded, October 18, 2016
Criteria updated October 30, 2018: Trametinib and/or Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Not to be used after progression on an alternate BRAF inhibitor and/or MEK inhibitor. 

Funded, September 15, 2014
Monotherapy treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (either previously untreated or treated with chemotherapy) with an ECOG performance status of 0 or 1; if brain metastases are present, patients should be asymptomatic or stable.
Trametinib is not approved in patients who have progressed on prior BRAF inhibitor therapy. 

Funded, October 16, 2014
For monotherapy treatment of patients with BRAF V600 mutuation-positive unresectable or metastic melanoma (either previously untreated or treated with chemotherapy) with ECOG performance of 0 or 1. If brain metastases are present, they should be stable. Treatment should continue until disease progression or the development of unacceptable toxicity.
Exclusions: Mekinist is not approved in patients who have progressed on a prior BRAF inhibitor therapy. 

Funded, October 3, 2014
• As monotherapy for the first–line treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma with ECOG performance status of 0 or 1. If brain metastases are present, patients should be stable.
• As monotherapy for the second–line treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma for patients who have progressed after receiving chemotherapy treatment in the first line setting with ECOG performance status of 0 or 1. If brain metastases are present, patients should be stable.
Clinical Notes:
• Recommended Dose: 2 mg once daily until disease progression or development of unacceptable toxicity requiring discontinuation of trametinib.
• Trametinib will not be reimbursed in patients who have progressed on a prior BRAF therapy.
Claim Notes:
• Initial approval duration: 6 months
• Renewal approval duration: 6 months 

Funded, August 1, 2014
As monotherapy treatment for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (either previously untreated or treated with chemotherapy) with ECOG performance of 0 or 1. If brain metastases are present, patients should be stable. Treatment should continue until disease progression or the development of unacceptable toxicity.
Note: Mekinist is not approved in patients who have progressed on a prior BRAF inhibitor therapy. 

*Under provincial consideration means that the province is reviewing pCODR’s recommendation. This may include the province working with the drug manufacturer to reach an agreement for a drug product that both parties can accept, in particular in cases where the pCODR Expert Review Committee has recommended that the drug be funded only on the condition of cost-effectiveness being improved to an acceptable level. This may occur before or after the pan-Canadian Pricing Alliance negotiations. 

Funded, August 19, 2014
First-line setting initial requests:

• As monotherapy for the first-line treatment of patients with BRAF V600 mutation-positive unresectable melanoma or metastatic disease.
• If brain metastases are present, they should be stable.

Recommended Dose: 2 mg once daily until disease progression or development of unacceptable toxicity requiring discontinuation of trametini

Approval duration: 6 months (patients should have their disease status assessed at least every 3 months) Requests for Mekinist for patients who have initiated another BRAF therapy (i.e. Zelboraf, Tafinlar) and who have not had disease progression will be considered on a case by case basis.
Second-line setting initial requests:

• As monotherapy, for the second–line treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma for patients who have progressed after receiving chemotherapy treatment in the first–line setting.
• If brain metastases are present, they should be stable
  Recommended Dose: 2 mg once daily until disease progression or development of unacceptable toxicity requiring discontinuation of trametinib
  Approval duration: 6 months (patients should have their disease status assessed at least every 3 months)
   

Exclusion criteria:

• BRAF V600 negative, or wild–type tumours, or unknown status will not be funded
• Trametinib will not be considered for funding in patients who have progressed on a prior BRAF inhibitor therapy
• Combination therapy with Tafinlar will not be considered for funding

as monotherapy, for first-line or second-line treatment following a failure with chemotherapy or with immunotherapy targeting the PD-1 or the CTLA-4, of an unresectable or metastatic melanoma with a BRAF V600 mutation, in persons: • with a contraindication or a serious intolerance to a BRAF inhibitor; and • whose ECOG performance status is 0 or 1. Appendix IV – 158 The maximum duration of each authorization is four months. When requesting continuation of treatment, the prescriber must provide evidence of a beneficial clinical effect by the absence of disease progression, confirmed by imaging or based on a physical examination. It must be noted that trametinib is not authorized after a BRAF inhibitor has failed if it was administered to treat a melanoma.

Funded October 29, 2018
Melanoma – advanced (unresectable or metastatic). For the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.  

Clinical Notes:
1. Patients must have an ECOG performance status of 0 or 1.
2. If brain metastases are present, patients should be asymptomatic or have stable symptoms.
3. Treatment should be discontinued upon disease progression or unacceptable toxicity. Patients must apply for coverage under the High-Cost Drug Program. If written by an oncologist, this medication does not require the submission of a Pharmacare Special Authorization form.