Package advice brexucabtagene autoleucel (Tecartus®) refractory mantle cell lymphoma
The National Health Care Institute advises the Minister not to include brexucabtagene autoleucel (Tecartus®) in the basic health care package for the treatment of adult patients with recurrent or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy, including a Brutons-tyrosine kinase inhibitor (BTK inhibitor). Reimbursement of brexu-cel at the marketing authorisation holder’s current asking price would lead to a substantial, socially unjustifiable budget impact. The reason for this advice was brexu-cel being placed in the lock procedure for expensive medicinal products.
Registered indication
Reimbursement is requested for the treatment of adult patients with recurrent or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy, including a Brutons-tyrosine kinase inhibitor (BTK inhibitor).
Package advice
The National Health Care Institute assessed brexu-cel on the basis of the 4 package criteria : effectiveness , cost-effectiveness , necessity and feasibility.
Brexu-cel meets the established medical science and medical practice. However the cost-effectiveness analysis provided by the marketing authorisation holder is of insufficient quality, despite the fact that the marketing authorisation holder has been given the opportunity to improve it. Therefore the National Health Care Institute advises the Minister not to include brexucabtagene autoleucel (Tecartus®) in the basic health care package for the mentioned indication. We cannot advise the Minster regarding any price negotiations he might conduct, which is essential, because the reimbursement of brexu-cel at the marketing authorisation holder’s current asking price would lead to a substantial, socially unjustifiable budget impact.
The National Health Care Institute invites the marketing authorisation holder to modify and better substantiate the pharmaco-economic analysis.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.