Funded, Dec 1, 2014
For BRAF V600 mutation-positive unresectable or metastatic melanoma patients with ECOG 0 or 1; If brain metastases are present, patients should be asymptomatic or stable.
BCCA “Compassionate Access Program” request with appropriate clinical information for each patient must be approved prior to treatment.
Note: only one anti-BRAF therapy will be funded

Funded, Mar 30, 2015
Criteria updated Oct. 30, 2018: Dabrafenib and/or trametinib 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, Sep 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.
Dabrafenib is not approved in patients who have progressed on prior BRAF inhibitor therapy.

Funded, Oct 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, patients should be asymptomatic or stable.
Treatment should continue until disease progression or the development of unacceptable toxicity.
Exclusions: Tafinlar is not approved in patients who have progressed on a prior BRAF inhibitor therapy.

Funded, Aug 19, 2014
1st Line Setting Initial requests:
•As monotherapy for the first (1st) line treatment of patients with BRAF V600 mutation-positive unresectable melanoma or metastatic disease.
•If brain metastases are present, they should be asymptomatic or stable.
Recommended Dose: 150 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of dabrafenib
Approval duration: 6 months (Patients should have their disease status assessed at least every 3 months).
Requests for Tafinlar for patients who have initatied another BRAF therapy (i.e. Zelboraf, Mekinist) and who have not had disease progression will be considered on a case by case basis
2nd Line Setting Initial requests:
•As monotherapy, for the second (2nd) 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 asymptomatic or stable
Recommended Dose: 150 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of dabrafenib
Approval duration: 6 months (Patients should have their disease status assessed at least every 3 months)
Exclusion Criteria:
•BRAF V600 negative, or wild type tumors, or unknown status will not be funded
•Dabrafenib will not be considered for funding in patients who have progressed on a prior BRAF inhibitor therapy
•Combination therapy with Mekinist will not be considered for funding

*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. Please contact the specific provincial drug p

Funded, Oct 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 asymptomatic or 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 asymptomatic or stable.
Clinical Notes:
• Recommended Dose: 150 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of dabrafenib.
• Dabrafenib 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, Aug 1, 2014
Monotherapy treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (either previously untreated or treated with chemotherapy) with ECOG performance status of 0 or 1. If brain metastases are present, patients should be asymptomatic or stable. Treatment should continue until disease progression or the development of unacceptable toxicity.
Note: TAFINLAR is not approved in patients who have progressed on a prior BRAF inhibitor therapy.

Funded Oct 29, 2018
Melanoma – Advanced (Unresctable or Metastatic) -For the treatment of patients with BRAF V600 mutationpositive 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.