B
Blinatumomab
Subsidy Information and Financing Scheme
Medical Assistance Fund
Cancer Drug and Clinical Indication listed in the MediShield Life Outpatient Cancer Drug List
Availability of ACE Drug Guidance
Yes
Post-marketing information
Biologics Drug Information Overview
Yes
Active ingredient: Blinatumomab
General information
Subsidy Information and Financing Scheme
[MAF] Blinatumomab (Blincyto) Infusion 35 mcg
Treatment of B-precursor acute lymphoblastic leukaemia in first or subsequent complete remission with minimal residual disease (MRD) for:
– up to a maximum of one cycle for induction in a lifetime for this indication;
– and up to three additional cycles for consolidation in a lifetime for this indication.
Complete remission is defined as a patient who has:
(a) 5% or less bone marrow blasts; and
(b) no evidence of disease; and
(c) a full recovery of peripheral blood counts with platelet count of more than or equal to 100,000 per microlitre; and
(d) absolute neutrophil count of more than or equal to 1,000 per microlitre.Treatment of relapsed or refractory B-precursor acute lymphoblastic leukaemia for:
– up to a maximum of two cycles for induction in a lifetime; and
– up to three additional cycles for consolidation in a lifetime in patients who achieve a complete response after induction.
Patients with Philadelphia chromosome positive disease must have previously received a tyrosine kinase inhibitor before receiving blinatumomab.
Patients must not have received blinatumomab previously for the treatment of minimal residual disease (MRD)-positive B-ALL or in the front-line consolidation phase of multiphase chemotherapy, unless there is a relapse-free period of at least six months following completion of treatment with blinatumomab.
Complete response is defined as a patient who has:
(a) 5% or less bone marrow blasts; and
(b) no evidence of disease; and
(c) platelet count of more than 50,000 per microlitre; and
(d) absolute neutrophil count of more than 500 per microlitre.Treatment of newly diagnosed patients with CD-19-positive B-precursor acute lymphoblastic leukaemia in the front-line consolidation phase of multiphase chemotherapy with documented complete remission (CR) or CR with incomplete haematologic recovery (CRi) after induction therapy for a maximum of four cycles in total.
CR is defined as a patient who has:
(a) 5% or less bone marrow blasts; and
(b) no evidence of disease; and
(c) a full recovery of peripheral blood counts with platelet count of more than or equal to 100,000 per microlitre; and
(d) absolute neutrophil count (ANC) of more than or equal to 1,000 per microlitre.
CRi is defined as a patient who: meets all the criteria for CR except without recovery of platelet count (platelets less than 100,000 per microlitre and ANC more than or equal to 1,000 per microlitre) or without recovery of ANC (platelets more than or equal to 100,000 per microlitre and ANC less than 1,000 per microlitre).
[MSHL] Blinatumomab Powder For Infusion 35 mcg vial
Treatment of B-precursor acute lymphoblastic leukaemia in first or subsequent complete remission with minimal residual disease (MRD) for:
– up to a maximum of one cycle for induction in a lifetime for this indication; and
– up to three additional cycles for consolidation in a lifetime for this indication.
Complete remission is defined as a patient who has:
a. 5% or less bone marrow blasts; and
b. no evidence of disease; and
c. a full recovery of peripheral blood counts with platelet count of more than or equal to 100,000 per microlitre; and
d. absolute neutrophil count (ANC) of more than or equal to 1,000 per microlitre.Treatment of relapsed or refractory B-precursor acute lymphoblastic leukaemia (r/r B-ALL) for:
– up to a maximum of two cycles for induction in a lifetime; and
– up to three additional cycles for consolidation in a lifetime in patients who achieve a complete response after induction.
Patients with Philadelphia chromosome positive disease must have previously received a tyrosine kinase inhibitor before receiving blinatumomab.
Patients must not have received blinatumomab previously for the treatment of minimal residual disease (MRD)-positive B-ALL or in the front-line consolidation phase of multiphase chemotherapy, unless there is a relapse-free period of at least six months following completion of treatment with blinatumomab.
Complete response is defined as a patient who has:
a. 5% or less bone marrow blasts; and
b. no evidence of disease; and
c. platelet count of more than 50,000 per microlitre; and
d. absolute neutrophil count of more than 500 per microlitreTreatment of newly diagnosed patients with CD-19-positive B-precursor acute lymphoblastic leukaemia in the front-line consolidation phase of multiphase chemotherapy with documented complete remission (CR) or CR with incomplete haematologic recovery (CRi) after induction therapy for a maximum of four cycles in total.
CR is defined as a patient who has: (a) 5% or less bone marrow blasts; and (b) no evidence of disease; and (c) a full recovery of peripheral blood counts with platelet count of more than or equal to 100,000 per microlitre; and (d) absolute neutrophil count (ANC) of more than or equal to 1,000 per microlitre.
CRi is defined as a patient who: Meets all the criteria for CR except without recovery of platelet count (platelets less than 100,000 per microlitre and ANC more than or equal to 1,000 per microlitre) or without recovery of ANC (platelets more than or equal to 100,000 per microlitre and ANC less than 1,000 per microlitre).
Drug Guidance for Subsidy
The Ministry of Health’s Drug Advisory Committee has recommended:
Blinatumomab 35 mcg powder for infusion for treating relapsed or refractory B-precursor acute lymphoblastic leukaemia (r/r B-ALL) for:
up to a maximum of two cycles for induction in a lifetime; and
up to three additional cycles for consolidation in a lifetime in patients who achieve a complete response after induction.
Funding status
[R] Blinatumomab 35 mcg powder for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 September 2020.
Clinical indication, subsidy class and MediShield Life claim limit for blinatumomab are provided in the Annex.
01/04/2026 Review of cancer drugs for Acute Lymphoblastic Leukaemia
The Ministry of Health’s Drug Advisory Committee has recommended:
Blinatumomab powder for infusion 35 mcg/vial;
Dasatinib 20 mg, 50 mg and 70 mg tablets;
Ponatinib 15 mg tablets; and
Inotuzumab ozogamicin 1 mg powder for concentrate for solution for infusion
for treating acute lymphoblastic leukaemia (ALL) in line with specific clinical criteria.
Funding status
[R] Blinatumomab powder for infusion 35 mcg/vial is recommended for inclusion on the Medication Assistance Fund (MAF) with effect from 4 January 2022a for treating patients with B-precursor ALL in first or subsequent complete remission with minimal residual disease (MRD) for:
up to a maximum of one cycle for induction in a lifetime for this indication; and
up to three additional cycles for consolidation in a lifetime for this indication.
[R] Dasatinib 20 mg, 50 mg and 70 mg tablets are recommended for inclusion on MAF with effect from 1 September 2022 for treating patients with:
newly diagnosed Philadelphia chromosome positive ALL (Ph+ALL) in combination with chemotherapy; or
Ph+ALL with resistance or intolerance to prior treatment with imatinib.
[R] Ponatinib 15 mg tablet is recommended for inclusion on MAF with effect from 1 September 2022 for treating patients:
with Ph+ALL who are resistant to dasatinib;
who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or
who have the T315I mutation.
[R] Inotuzumab ozogamicin 1 mg powder for concentrate for solution for infusion is recommended for inclusion on MAF with effect from 1 April 2022 for treating patients with relapsed or refractory CD22 positive B-precursor ALL for:
up to a maximum of three cycles for induction in a lifetime; and
up to three additional cycles for consolidation in a lifetime for patients who achieve a complete response after induction.
Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.
arevised clinical indication with effect from 1 Apr 2026.
The Ministry of Health’s Drug Advisory Committee has recommended:
Blinatumomab 35 mcg powder for infusion for treating newly diagnosed patients with CD-19-positive B-precursor acute lymphoblastic leukaemia in the front-line consolidation phase of multiphase chemotherapy with documented complete remission (CR) or CR with incomplete haematologic recovery (CRi) after induction therapy for a maximum of four cycles in total.
in view of acceptable clinical effectiveness and safety, and an acceptable pricing proposal by the company.
Funding status
[R] Blinatumomab 35 mcg powder for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 April 2026.
Clinical indication, subsidy class and MediShield Life claim limit for blinatumomab are provided in the Annex.
General Availability in Public Healthcare Institution
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
Availability information
Formulation | Public Healthcare Institution |
|---|---|
Blincyto Infusion 35 mcg |
|