Daratumumab

The Ministry of Health’s Drug Advisory Committee has not recommended daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (DBCd) for inclusion on the MOH List of Subsidised Drugs for treating patients with newly diagnosed light chain (AL) amyloidosis in view of the uncertain extent of clinical benefit and uncertain cost-effectiveness compared with the current treatment option.

Clinical indication, subsidy class and MediShield Life claim limit for daratumumab for AL amyloidosis are provided in the Annex.

The Ministry of Health’s Drug Advisory Committee has not recommended daratumumab in combination with bortezomib, thalidomide and dexamethasone (DBTd), daratumumab in combination with lenalidomide and dexamethasone (DLd), and daratumumab in combination with bortezomib, melphalan and prednisone (DBMP) for inclusion on the MOH List of Subsidised Drugs for treating newly diagnosed multiple myeloma at the price proposed by the manufacturer.

The DBTd and DLd regimens have not been recommended in view of the uncertain extent of clinical benefit and uncertain cost-effectiveness compared with alternative treatments.

The DBMP regimen has not been recommended in view of low clinical need for this treatment in local practice.

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

Carfilzomib 30 mg powder for solution for infusion, ixazomib 3 mg and 4 mg capsules and pomalidomide 1 mg, 2 mg, 3 mg and 4 mg capsules are recommended for inclusion on the Medication Assistance Fund (MAF) in line with the abovementioned indication.

MAF assistance for carfilzomib will be implemented from 4 January 2022. MAF assistance for ixazomib and pomalidomide will be implemented from 1 September 2022.

MAF assistance does not apply to daratumumab 100 mg/5 ml and 400 mg/20 ml concentrate for solution for infusion and 1800 mg/15 ml solution for subcutaneous injection when used for previously treated multiple myeloma.

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