Daratumumab [Darzalex]

[MSHL] Daratumumab Concentrate For Solution For Infusion 100 mg/5 mL, 400 mg/20 mL

1. Daratumumab in combination with bortezomib, thalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.

2. Daratumumab in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received at least one prior therapy.

3. Daratumumab in combination with bortezomib and dexamethasone for patients with multiple myeloma who have received at least one prior therapy.

4. Daratumumab in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for an autologous stem cell transplant.

[MSHL] Daratumumab SC Solution For Injection 1,800 mg/15 mL

1. Daratumumab in combination with bortezomib, thalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.

2. Daratumumab in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received at least one prior therapy.

3. Daratumumab in combination with bortezomib and dexamethasone for patients with multiple myeloma who have received at least one prior therapy.

4. Daratumumab in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for an autologous stem cell transplant.

5. Daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for patients with previously untreated light chain (AL) amyloidosis. Treatment with daratumumab should be continued until disease progression or for a maximum of 24 cycles.

Legend

This section shows the following:

• Subsidy Scheme and Clinical Indication (where applicable) of drugs listed in the MOH List of Subsidised Drugs

• Subsidised brands of vaccines recommended in the National Immunisation Schedules listed in the MOH Subsidised Vaccine List

• Cancer Drug and Clinical Indication listed in the MediShield Life Cancer Drug List

As this website is updated monthly, please refer to MOH List of Subsidised Drugs, MOH Subsidised Vaccine List or MediShield Life Cancer Drug List for the most updated information.

08/02/2023 Daratumumab for treating newly diagnosed light chain (AL) amyloidosis

[NR] 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.

12/07/2022 Daratumumab-based regimens for newly diagnosed multiple myeloma

[NR] 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.

[NR] 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.

[NR] 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.

04/01/2022 Review of cancer drugs for previously treated multiple myeloma

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

• 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

for previously treated multiple myeloma in line with specific clinical criteria.

Carfilzomib, ixazomib and pomalidomide should be used in line with the recommended treatment regimens listed in the Annex.

Subsidy status

[R] 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.

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

[NR] 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.

Legend

This section displays recommendation from the MOH Drug Advisory Committee for subsidy and appropriate use of the drug as extracted from the Agency for Care Effectiveness (ACE) Drug Guidances. As this website is updated monthly, please refer to the ACE website for the most updated information.

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