Product Details

Zelboraf

Vemurafenib
240 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

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Vemurafenib

  • Brand(s): Zelboraf
  • Dosage Form/Strength: 240 mg tablet

Initiation requests:

For the treatment of patients with BRAF V600 mutation-positive unresectable stage Ill or stage IV melanoma.

  1. As monotherapy or as combination therapy with cobimetinib

  2. If brain metastases are present, they should be asymptomatic or stable

Exclusion Criteria:

  • BRAF V600 negative, or wild type tumors, or unknown status will not be funded

  • The Ministry will fund only one BRAF mutation targeted treatment/treatment regimen.

  • May be sequenced after immunotherapies or other funded treatments, however, treatment beyond third line will not be considered for funding.

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:

  • 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.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph