Drug Guidance for Subsidy 19/12/2022 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 ... See all × 19/12/2022 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 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 RDabrafenib 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. RNivolumab 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. RNivolumab 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. RMAF 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. NRMAF 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.
Post Marketing Information 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
General Availability in Public Healthcare Institution Users are to consult the respective PHIs for actual inventory availability and supply restrictions/consideration Tablet, Film Coated 240 mg National University Hospital