Funded, Sept 1, 2017
In combination with vemurafenib for Previously untreated BRAF V600 mutation-positive unresectable or metastatic melanoma stage III or IV:
• Good performance status
• Life expectancy of at least 3 months
• 18 years and older (for patients younger than 18 years old, CAP will review the eligibility on a case-by-case basis)
• Adequate hematological, hepatic and renal function
• If brain metastases are present, they must have been previously treated and be stable
• A BCCA “Compassionate Access Program” request with appropriate clinical information for each patient must be approved prior to treatment

Note: only one BRAF/MEK targeted treatment will be funded (daBRAFenib, trametinib, or combination)

Funded, Nov 28, 2017
Criteria updated Oct. 30, 2018: For the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation in combination with vemurafenib Not to be used if progression on treatment with alternative BRAF inhibitor and/or MEK inhibitor.

Funded, Sept 1, 2017
In combination with Vemurafenib, for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage Ill or stage IV melanoma who have a good performance status.

Funded, Oct 19, 2017
In combination with Zelboraf (vermurafenib), for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage III or stage IV melanoma who have a good performance status. Treatment should continue until unacceptable toxicity or disease progression. If brain metastases are present, patients should be asymptomatic or have stable symptoms.

Funded, Nov 17, 2017
Initial requests: For the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage Ill or stage IV melanoma who have a good performance status (ECOG ≤ 2). As first-line combination therapy with vemurafenib; AND If brain metastases are present, they should be asymptomatic or stable Recommended Dose as combination dual therapy with Vemurafenib: Cobimetinib 60mg once daily for 21 days, followed by seven days off treatment; AND Vemurafenib 960mg twice daily for 28 days. Both drugs are given until disease progression or unacceptable toxicity. Renewal requests: Combination dual therapy may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation. Letter from physician outlining radiological and clinical benefit requiring continuation of the drug and verification of no disease progression or development of unacceptable toxicity must be submitted. Requests in patients who have initiated another BRAF and/or MEK inhibitor as monotherapy or combination therapy will be considered on a case-by-case basis ONLY IF there has been no disease progression.

Funded,  June 1, 2020
In combination with vemurafenib for patients with previously untreated BRAFV600 mutation-positive unresectable stage III or stage IV melanoma. Patients should have a good performance status. If brain metastases are present, patients should be asymptomatic or have stable symptoms. Treatment should continue until unacceptable toxicity or disease progression. Use of the combination of cobimetinib and vemurafenib precludes the use of any other BRAF targeted therapy as a subsequent line of therapy following disease progression. Exceptions will be considered in cases of intolerance without progression. For BRAF-positive patients, BRAF-targeted therapy and immunotherapy (including nivolumab plus ipilimumab combination therapy) may be sequenced in either order upon treatment failure, based on clinician assessment.

Funded, Sept 22, 2017
For the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, when used as first line therapy, in combination with vemurafenib. Renewal criteria: Written confirmation that the patient has responded to treatment and there is no evidence of disease progression. Clinical Notes: 1. Patients must have a good performance status. 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. Claim Notes: Cobimetinib will not be reimbursed in patients who have progressed on BRAF targeted therapy. Initial approval duration: 6 months Renewal approval duration: 6 months.

Funded, Jun 1, 2017
In combination with vemurafenib, for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage III or stage IV melanoma who have a good performance status. Treatment should continue until unacceptable toxicity or disease progression. If brain metastases are present, patients should be asymptomatic or have stable symptoms.

Funded, Aug 1, 2018
In combination with vemurafenib, for the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage III or stage IV melanoma who have a good performance status. Treatment should continue until unacceptable toxicity or disease progression. If brain metastases are present, patients should be asymptomatic or have stable symptoms. Approvals are for a maximum daily dose of 60mg during 21 consecutive days per 28 day cycle. The request for coverage must be made and the medication prescribed by a specialist in haematology or medical oncology, or a general practitioner acting under the direction of those specialists.