Product Details
Zelboraf
Vemurafenib240 mg
Tablet
DIN/PIN/NPN
02380242
Manufacturer
Hoffmann-La Roche Limited
Formulary Listing Date
2019-04-30
Unit Price
35.5539
Amount MOH Pays
35.5539
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L01EC01
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Oncology Drugs | Vemurafenib
Initiation requests: For the treatment of patients with BRAF V600 mutation-positive unresectable stage Ill or stage IV melanoma.
Exclusion Criteria:
Renewal requests: 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 or development of unacceptable toxicity 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 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. Recommended Dose as Monotherapy: 960 mg twice daily until disease progression or development of unacceptable toxicity requiring discontinuation of vemurafenib. Recommended Dose as combination dual therapy with Cobimetinib:
EAP Drug Request Form: |