About Targeted Therapies
cobimetinib (Cotellic) + vemurafenib (Zelboraf)
debrafenib (Tafinlar) + trametinib (Mekinist)
MONO TARGETED THERAPIES
debrafenib (Tafinlar)
Dabrafenib (Tafinlar):
Dabrafenib (Tafinlar) is a first line treatment for patients with BRAF V600 mutation-positive unresectable stage IIIC or IV melanoma or metastatic melanoma. About half of all melanoma skin cancers make too much BRAF due to a change in a gene. Dabrafenib acts as an inhibitor of the BRAF protein and slows down or stops the growth of cancer cells. The drug is administered as a pill taken daily.
- for more information visit Novartis Canada
Side Effects
The most common side effects from Tafinlar included thickening of the skin, non-cancerous skin tumors, headache, fever, joint pain, hair loss, and hand-foot syndrome. Less common, but more serious side effects included an increased risk of another type of skin cancer (squamous cell carcinoma); fever complicated by low blood pressure, shaking chills, dehydration, and kidney failure; eye problems; and increased blood sugar levels.
Always talk to your doctor, pharmacist or nurse about your side effects so they can help you manage them.
Reference: https://www.cancer.org/latest-news/fda-approves-2-new-melanoma-drugs.html
Provincial Funding Summary
Dabrafenib (Tafinlar) for Metastatic Melanoma (pCODR 10025)
This information is current as of November 9, 2018.
Note: Funding criteria as listed on the decision date. Please refer to the provincial drug programs for the most recent funding criteria and program eligibility.
BC Funded
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
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
AB 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.
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.
SK Funded
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.
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.
MB Funded
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.
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.
ON Funded
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
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
NS Under provincial consideration
*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
NB Funded
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
• 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
NL Funded
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.
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.
PEI Under provincial consideration
*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
Please note: This information is not meant to act as a treatment decision aid, but rather to provide general information about which metastatic melanoma or skin cancer treatments are covered by provincial health care plans in Canada. It is current to the date indicated and may not be currently accurate due to the changing landscape of coverage in Canada. If you have private insurance coverage, you may have access to therapies not covered by the provincial plans in your province. All information obtained about specific treatments should be further discussed with your physician.
HELPFUL RESOURCES
Melanoma What You Need To Know
A leading national melanoma resource written with the help of specialists in oncology and health care.
Watch Now Melanoma Updates and Treatments
Melanoma Support
The Melanoma Network of Canada has a number of free services for patients, caregivers and healthcare professionals.