Monograph

Based on the available evidence, the Ministry of Health’s Drug Advisory Committee has recommended:

• Abemaciclib 50 mg, 100 mg and 150 mg tablets;
• Abiraterone acetate 250 mg tablets;
• Afatinib 20 mg, 30 mg and 40 mg tablets;
• Alectinib 150 mg capsule;
• Anagrelide 0.5 mg capsule;
• Atezolizumab 840 mg/14 mL and 1200 mg/20 mL concentrate for solution for infusion;
• Avelumab 200 mg/10 mL concentrate for solution for infusion;
• Axitinib 1 mg and 5 mg tablets;
• Azacitidine 100 mg injection;
• Bendamustine 25 mg and 100 mg concentrate for infusion;
• Bicalutamide 50 mg tablet;
• Bortezomib 3.5 mg injection;
• Brentuximab vedotin 50 mg powder for concentrate for solution for infusion;
• Brigatinib 30 mg, 90 mg and 180 mg tablets;
• Cabozantinib 20 mg, 40 mg and 60 mg tablets;
• Ceritinib 150 mg capsule;
• Cetuximab 100 mg/20 mL solution for infusion;
• Cisplatin 100 mg/100 mL concentrate for infusion;
• Cyproterone 50 mg tablet;
• Dabrafenib 50 mg and 75 mg capsules;
• Dasatinib 20 mg, 50 mg and 70 mg tablets;
• Durvalumab 120 mg/2.4 mL and 500 mg/10 mL concentrate for solution for infusion;
• Epirubicin 50 mg/25 mL injection;
• Eribulin mesylate 1 mg/2 mL solution for injection;
• Erlotinib 100 mg and 150 mg tablets;
• Exemestane 25 mg tablet;
• Fludarabine phosphate 50 mg injection;
• Fulvestrant 250 mg/5 mL solution for injection;
• Gefitinib 250 mg tablet;
• Gilteritinib fumarate 40 mg tablet;
• Goserelin 3.6 mg and 10.8 mg depot injections;
• Imatinib 100 mg and 400 mg tablets;
• Ipilimumab 50 mg/10 mL concentrate for solution for infusion;
• Lapatinib 250 mg tablets;
• Lenalidomide 5 mg, 10 mg, 15 mg and 25 mg capsules;
• Leuprorelin acetate 3.75 mg and 11.25 mg depot injection;
• Lorlatinib 25 mg and 100 mg tablets;
• Megestrol 40 mg and 160 mg capsules;
• Midostaurin 25 mg capsule;
• Nilotinib 50 mg, 150 mg and 200 mg capsules;
• Nivolumab 40 mg/4 mL and 100 mg/10 mL concentrate for solution for infusion;
• Obinutuzumab 1000 mg/40 mL concentrate for solution for infusion;
• Olaparib 100 mg and 150 mg tablets;
• Oxaliplatin 200 mg/40 mL concentrate for infusion;
• Paclitaxel-albumin bound nanoparticles 100 mg injectable suspension;
• Palbociclib 75 mg, 100 mg and 125 mg capsules/tablets;
• Pazopanib 200 mg and 400 mg tablets;
• Pegylated liposomal doxorubicin 20 mg concentrate for infusion;
• Pembrolizumab 100 mg/4 mL solution for infusion;
• Pemetrexed 100 mg and 500 mg injections;
• Ponatinib 15 mg tablet;
• Ribociclib 200 mg tablet;
• Ruxolitinib 5 mg, 15 mg and 20 mg tablets;
• Somatropin 5 mg/1.5 mL and 10 mg/1.5 mL prefilled pens and solution for injection;
• Somatropin 4 mg and 5.3 mg/mL powder and solvent for solution for injection;
• Somatropin 5.83 mg/mL and 8 mg/mL solution for injection;
• Sunitinib 12.5 mg capsules;
• Trametinib 0.5 mg and 2 mg tablets; and
• Vinorelbine 50 mg/5 mL injection

for inclusion on the MOH Standard Drug List (SDL) or Medication Assistance Fund (MAF) in line with their registered indications or specific clinical criteria for treating cancer, in view of clinical need, and acceptable clinical and cost effectiveness.

Drugs that have not been recommended for subsidy are listed in the Annex.

For all drugs, the clinical indications, subsidy class, subsidy implementation dates (if applicable), and MediShield Life claim limits are provided in the Annex.

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.

Dabrafenib 50 mg and 75 mg capsules and trametinib 0.5 mg and 2 mg tablets are recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication with effect from 4 January 2022.

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