Thomas Gould
Question:2815. Deputy Thomas Gould asked the Minister for Health the timeline for the implementation of CAR-T therapy here. [39240/21]
View answerTuesday, 27 July 2021
Questions (2815)
Written answers
CAR-T is a novel treatment for patients with cancer. It is a patient-specific, individualised cell therapy that consists of genetically modifying the patient’s own T lymphocytes. Two CAR-T therapies were licensed as medicines by the EU in 2018 and a further one was licensed in late 2020.
Although licensed as a medicine by the EMA, there are technical processes required to support the use of CAR-T therapy which are more multifaceted than standard drug administration. These involve a complex supply chain, laboratory accreditation and other specific supports to be in place in addition to the drug reimbursement approval. As a result, CAR-T can only be carried out at designated, accredited centres that have been assessed and accredited from a quality control and a process management perspective. The administration of CAR-T must occur in hospitals with the appropriate infrastructure and trained staff.
In preparation for a CAR-T service in Ireland the NCCP has:
- formally designated the National Stem Cell Transplantation unit at St James’s Hospital (SJH) and the Haematopoietic Stem Cell Transplant Unit in Children's Health Ireland at Crumlin as the initial sites to deliver this service for adult and paediatric patients on the island of Ireland;
- supported SJH and CHI at Crumlin in progressing the technical/service readiness elements required;
- agreed a service specification and a patient pathway for adult and paediatric patients whereby all patients to be considered for CAR-T must be discussed at the appropriate multidisciplinary team (MDT) meeting in the designated CAR-T centre. This agreed pathway will ensure that there is a clear clinical governance structure in place for these services; and
- agreed the basis of a national CAR-T Review Group whose role will be to consider all patients who have been referred for discussion at the designated CAR-T centre MDT meeting and to prioritise patients for treatment based on assessment of information regarding patient fitness, disease severity and available capacity.
Service planning discussions are ongoing involving the NCCP, service providers and pharmaceutical companies to move forward on a CAR-T service in Ireland. It is hoped that the service will be operational for both adult and paediatric patients by end 2021.
Question No. 2816 answered with Question No. 2798.