Tisagenlecleucel-T (Kymriah®) for the treatment of ALL
The National Health Care Institute carried out an assessment of the medicinal product tisagenlecleucel-T (Kymriah®) for the treatment of ALL. Due to its expected high costs the Minister placed tisagenlecleucel in the 'waiting room' or 'sluice'.
These products can only be accepted into the insured package after the National Health Care Institute has advised on their inclusion in the insured package and, where applicable, subject to Ministry negotiations to arrive at a financial arrangement with the supplier.
Registration
Tisagenlecleucel is an autologous immunocellular cancer therapy. In order to produce tisagenlecleucel, patients’ own T cells have to be obtained via leukapheresis. These cells are subsequently genetically modified, ex vivo, by using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR). After the patient has undergone pre-treatment with lymphodepleting chemotherapy, his/her own (autologous) CAR-T cells (tisagenlecleucel) are returned to the patient via intravenous infusion.
Tisagenlecleucel is also registered for adult patients with a relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The advice for DLBCL will follow in the course of 2019.
The National Health Care Institute's advice
For the indication acute B cell lymphoblastic leukaemia, tisagenlecleucel complies with established medical science and medical practice. Including it in the package for this indication will have limited budget impact. As a result, it is eligible for inclusion in the standard health care benefit package. We will conclude an orphan drug arrangement and, due to the high treatment costs per patient, we will evaluate its use once it has been included in the insured package.
This report is a summary of recommendations by the National Health Care Institute. The original text of this excerpt is in Dutch.