Immune checkpoint inhibitors and BRAF/MEK inhibitors for treating advanced malignant melanoma

Published on 04 Jan 2022
Last Updated on 19 Dec 2022

Guidance Recommendations

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 and 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

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.

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.

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 MAF for treating advanced unresectable or metastatic malignant melanoma.

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.

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.

Immune Checkpoint Inhibitors and BRAF/MEK Inhibitors for treating advanced malignant melanoma (Updated 19 December 2022) [PDF, 176 KB]

Treatments for melanoma PES (Updated 31 Aug 22) [PDF, 108 KB]