Inotuzumab Ozogamicin [Besponsa]

[MAF] Inotuzumab ozogamicin (Besponsa) Infusion 1 mg

1. Treatment of patients with relapsed or refractory CD22 positive B-precursor acute lymphoblastic leukemia (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 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 inotuzumab.
   
   Complete response is defined as a patient who:
   a) has 5% or less bone marrow blasts; and
   b) has no evidence of disease; and
   c) has platelet count of more than 50,000 per microlitre; and
   d) has absolute neutrophil count of more than 500 per microlitre.

[MSHL] Inotuzumab Ozogamicin Powder For Concentrate For Solution For Infusion 1 mg per vial

1. Treatment of patients with relapsed or refractory CD22 positive B-precursor acute lymphoblastic leukemia (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 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 inotuzumab.
   
   Complete response is defined as a patient who:
   a) has 5% or less bone marrow blasts; and
   b) has no evidence of disease; and
   c) has platelet count of more than 50,000 per microlitre; and
   d) has absolute neutrophil count of more than 500 per microlitre.

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13/09/2024 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.

Subsidy status

[R] Blinatumomab powder for infusion 35 mcg/vial is recommended for inclusion on the Medication Assistance Fund (MAF) with effect from 4 January 2022^a 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; and

• up to three additional cycles for consolidation in a lifetime.

[R] Complete remission is defined as a patient who:
a) has 5% or less bone marrow blasts; and
b) has no evidence of disease; and
c) has a full recovery of peripheral blood counts with platelet count of more than 100,000 per microlitre; and
d) has absolute neutrophil count of more than 1,000 per microlitre.

[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.

[R] Patients with Philadelphia chromosome positive disease must have previously received a tyrosine kinase inhibitor before receiving inotuzumab.

[R] Complete response is defined as a patient who:
a) has 5% or less bone marrow blasts; and
b) has no evidence of disease; and
c) has platelet count of more than 50,000 per microlitre; and
d) has absolute neutrophil count of more than 500 per microlitre.

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 Nov 2024.

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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