Cell, Tissue, and Gene Therapy Product List

01 Aug 2024

The Ministry of Health (MOH) provides subsidies for Cell, Tissue, and Gene Therapy Products (CTGTPs) that have been assessed to be clinically and cost effective at our public healthcare institutions and included in the CTGTP List. You may refer to the CTGTP subsidy framework for more details regarding the subsidies available.

Cell, Tissue, and Gene Therapy Product List* (As of 1 Aug 2024)

* The CTGTP availability at each healthcare institution varies, depending on the clinical conditions commonly managed by the institution and the treatments usually prescribed by the doctors.

Active ingredient(s)	Brand	Dosage form	Strength(s)	Clinical indication(s)
Tisagenlecleucel	Kymriah	Cells dispersion for infusion	-	1) Treatment of patients between two to 25 years of age (both ages inclusive), with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, who also satisfy the requirements below: if the patient is <16 years of age, that patient is assessed to have a Lansky performance status of ≥50; if the patient is ≥16 years of age, that patient is assessed to have a Karnofsky performance status of ≥50; if the patient has Philadelphia-positive (PH+) B-cell ALL, that patient must: (i) be assessed to be intolerant to tyrosine kinase inhibitor (TKI) therapy; (ii) have failed at least two lines of TKI therapy; or (iii) be assessed to be contraindicated for TKI therapy; the patient must have been assessed according to a morphologic assessment to have ≥5% lymphoblasts and CD19 ALL positivity in the patient’s bone marrow; the patient must not have any of the following: (i) isolated extramedullary ALL relapse; (ii) any uncontrolled infection, including but not limited to HIV, active hepatitis B or active hepatitis C; (iii) any active central nervous system (CNS) involvement by ALL; (iv) any uncontrolled secondary CNS disease; or (v) any secondary CNS disease that is anticipated to be uncontrolled at the time of lymphocyte infusion; the patient must have sufficient organ function (e.g. renal, cardiac, and pulmonary function); and the patient must not have received any prior chimeric antigen receptor T-cell (CAR-T) treatments for B-cell ALL. 2) Treatment of patients 18 years of age and above with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, who also satisfy the requirements below: the patient must have failed or is ineligible for hematopoietic stem cell transplant; the patient must have an Eastern Cooperative Oncology Group (“ECOG”) performance status of 0 or 1; the patient must not have any of the following: (i) any uncontrolled infection, including but not limited to HIV, active hepatitis B, or active hepatitis C; (ii) any primary central nervous system (CNS) DLBCL; (iii) any uncontrolled secondary CNS disease; or (iv) any secondary CNS disease that is anticipated to be uncontrolled at the time of lymphocyte infusion; the patient must have sufficient organ function (e.g. renal, cardiac, and pulmonary function); and the patient must not have received any prior chimeric antigen receptor T-cell (CAR-T) treatments for DLBCL.

Active ingredient(s)

Brand

Dosage form

Strength(s)

Clinical indication(s)

Tisagenlecleucel

Kymriah

Cells dispersion for infusion

1) Treatment of patients between two to 25 years of age (both ages inclusive), with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, who also satisfy the requirements below:

if the patient is <16 years of age, that patient is assessed to have a Lansky performance status of ≥50;

if the patient is ≥16 years of age, that patient is assessed to have a Karnofsky performance status of ≥50;

if the patient has Philadelphia-positive (PH+) B-cell ALL, that patient must:
(i) be assessed to be intolerant to tyrosine kinase inhibitor (TKI) therapy;
(ii) have failed at least two lines of TKI therapy; or
(iii) be assessed to be contraindicated for TKI therapy;

the patient must have been assessed according to a morphologic assessment to have ≥5% lymphoblasts and CD19 ALL positivity in the patient’s bone marrow;

the patient must not have any of the following:
(i) isolated extramedullary ALL relapse;
(ii) any uncontrolled infection, including but not limited to HIV, active hepatitis B or active hepatitis C;
(iii) any active central nervous system (CNS) involvement by ALL;
(iv) any uncontrolled secondary CNS disease; or
(v) any secondary CNS disease that is anticipated to be uncontrolled at the time of lymphocyte infusion;

the patient must have sufficient organ function (e.g. renal, cardiac, and pulmonary function); and
the patient must not have received any prior chimeric antigen receptor T-cell (CAR-T) treatments for B-cell ALL.

2) Treatment of patients 18 years of age and above with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, who also satisfy the requirements below:

the patient must have failed or is ineligible for hematopoietic stem cell transplant;

the patient must have an Eastern Cooperative Oncology Group (“ECOG”) performance status of 0 or 1;

the patient must not have any of the following:
(i) any uncontrolled infection, including but not limited to HIV, active hepatitis B, or active hepatitis C;
(ii) any primary central nervous system (CNS) DLBCL;
(iii) any uncontrolled secondary CNS disease; or
(iv) any secondary CNS disease that is anticipated to be uncontrolled at the time of lymphocyte infusion;

the patient must have sufficient organ function (e.g. renal, cardiac, and pulmonary function); and

the patient must not have received any prior chimeric antigen receptor T-cell (CAR-T) treatments for DLBCL.

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