Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved cobimetinib in combination with vemurafenib for reimbursement as a treatment option for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF p.V600 mutation, as demonstrated by a validated test method.

This is written in the approval document as:

Cobimetinib and vemurafenib in combination are indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Reimbursement

CDS

Citation

Cobimetinib and Vemurafenib Therapy, 2024, version number 3, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6728/373_V3_Cobimetinib_and_Vemurafenib.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	BRAF p.V600E	Melanoma	Cobimetinib, Vemurafenib
HSE (1)	BRAF p.V600K	Melanoma	Cobimetinib, Vemurafenib

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2018-04-01	Health Service Executive	Indication approved for reimbursement.