Vemurafenib

Not Applicable

01/08/2025 Immune Checkpoint Inhibitors and BRAF/MEK Inhibitors for treating advanced malignant melanoma

The Ministry of Health’s Drug Advisory Committee has recommended:

• Dabrafenib 50 mg and 75 mg capsules and trametinib 0.5 mg and 2 mg tablets;

• Nivolumab 40 mg/4 mL, 100 mg/10 mL concentrate for solution for infusion;

• Nivolumab 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL concentrate for solution for infusion used in combination with ipilimumab 50 mg/10 mL concentrate for solution for infusion; and

• Pembrolizumab 100 mg/4 mL solution for infusion

for treating advanced malignant melanoma in line with specific clinical criteria.

Subsidy status

[R] Dabrafenib 50 mg and 75 mg capsules used in combination with trametinib 0.5 mg and 2 mg tablets are recommended for inclusion on the Medication Assistance Fund (MAF) for treating advanced unresectable or metastatic malignant melanoma in patients with a BRAF V600 mutation with effect from 4 January 2022.

[R] Nivolumab 40 mg/4 mL and 100 mg/10 mL concentrate for solution for infusion and pembrolizumab 100 mg/4 mL solution for infusion are recommended for inclusion on MAF for:

• adjuvant treatment of completely resected malignant melanoma with lymph node involvement; and

• treating advanced unresectable or metastatic malignant melanoma.

[R] Nivolumab 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL concentrate for solution for infusion used in combination with ipilimumab 50 mg/10 mL concentrate for solution for infusion are recommended for inclusion on the MAF for treating advanced unresectable or metastatic malignant melanoma.

[R] MAF assistance for nivolumab, ipilimumab and pembrolizumab will be implemented from 1 September 2022. Treatments should be given in line with the dosing regimens outlined in the Annex.

[NR] MAF assistance does not apply to:

• dabrafenib 50 mg and 75 mg capsules used in combination with trametinib 0.5 mg and 2 mg tablets for adjuvant treatment of completely resected BRAF V600 mutation positive malignant melanoma with lymph node involvement; and

• cobimetinib 20 mg and vemurafenib 240 mg tablets.

Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.

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DHCPL 02/02/2017 Zelboraf® (Vemurafenib) and the risks of Dupuytren's Contracture and Plantar Fascial Fibromatosis

DHCPL 23/04/2014 Risk of drug-induced liver injury (DILI) reported with Zelboraf® (vemurafenib)

DHCPL 31/07/2013 Risk of RAS-Mutant Malignancy Progression and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS Syndrome) associated with Zelboraf® (vemurafenib)

DHCPL 29/05/2013 Communication on risk of hepatotoxicity with concurrent use of Zelboraf® (vemurafenib) and ipilimumab

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Note:

General availability information reflected is based on the Public Healthcare Institutions’ (PHI) formulary on what is commonly used for treating their patient population and may or may not be available for patients not under the care of that institution. It does not reflect the PHI’s actual inventory availability and is subjected to change. Please consult the Public Hospitals or Polyclinics for details on availability and supply restrictions/considerations. General availability is not tied to any brand unless otherwise stated.

Users are to consult the respective PHIs for actual inventory availability and supply restrictions/consideration