Innovative CAR-T cell therapy set to be reimbursed by NICE

Tecartus (brexucabtagene autoleucel) is set to be reimbursed in England and Wales having received a recommendation for the Cancer Drugs Fund from NICE in its final draft guidance. Tecartus is one of many recent advanced therapy medicinal products (ATMPs) which are based on genes, tissues, or cells. As a CAR-T cell therapy, Tecartus reengineers the patient’s own cells in a laboratory to recognise and attack cancer cells when reintroduced to the patient.

Tecartus received marketing authorisation for “the treatment of adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor” on 14th December 2020. This recommendation from NICE marks the first full access deal in Europe. Germany is commonly the fastest European market to reimbursement due to procedural differences that uncouple initial reimbursement from the HTA process.

The NICE recommendation for the Cancer Drugs Fund allows access to Tecartus while additional data can be collected to reduce uncertainty on the curative extent of Tecartus. Inclusion on the Cancer Drugs Fund is conditional on the managed access agreement arranged between NICE and Kite (a Gilead company) and involves a confidential discount.

NICE are currently reviewing their methods and processes to produce guidance for health technologies with the aim to become faster and more efficient. While implementation of the resulting new processes is expected from October 2021, the short delay to recommendation seen with Tecartus may indicate what NICE are capable of.

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