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‘Exceptional’ request for Car T-cell therapy granted

By Paul Mulholland - 22nd Oct 2023

CAR T-cell

An ‘exceptional’ request was made earlier this year for a patient with acute lymphoblastic leukaemia (ALL), who was outside the approved age-range for Car T-cell therapy, to avail of the treatment, the Medical Independent (MI) has learned.

There is currently one Car T-cell medication (tisagenlecleucel) approved for reimbursement in line with the HSE assessment process for ALL.

In addition to other conditions, the licensed indication has an age caveat and the prospective recipient must be under the age of 25.

In early 2023, a consultant haematologist made a request to extend the licensed indication to allow use in a patient over 25.

In an email to Assistant National Director of the National Cancer Control Programme (NCCP), Ms Patricia Heckmann, seen by MI through Freedom of Information law, the consultant described the patient as “fit for more treatment with curative intent”.

“I am really keen to treat with a CAR T-cell product. [There is] no other licensed drug options available.”

Emails were subsequently sent by Ms Heckmann to the National Director of the NCCP, Prof Risteárd Ó Laoide, on the issue.

“Generally with such queries we inform people as to the approved reimbursed decision,” Ms Heckmann wrote in another email.

Ms Heckmann said while she had done this, she was informed the case was ‘exceptional’.

“In such cases we would escalate to you and then [the Chief Clinical Officer] as we cannot fund internally – this is also the approach acutes take as I understand it.”

Ms Heckmann said the Clinical Lead for the National Adult CAR T Centre at St James’s Hospital, Dublin, Dr Larry Bacon, “agrees and is willing to treat this patient outside of the licence.”

A HSE spokesperson told MI the request was approved by the Executive on an exceptional basis, with the patient being made aware of the unlicensed status of the treatment.

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