NICE recommends use of Janssen’s Imbruvica for Waldenström’s macroglobulinaemia


The National Institute for Health and Care Excellence (NICE) in the UK has recommended the use of Janssen Pharmaceutical’s Imbruvica (ibrutinib) on the Cancer Drugs Fund (CDF) to treat adults with a type of non-Hodgkin lymphoma called Waldenström’s macroglobulinaemia (WM).

Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor and blocks cell survival signals transmission within the malignant B cells by forming a covalent bond with the BTK protein.

The recommendation covers NICE’s marketing authorisation and patients who have had a minimum of one prior therapy.

NICE based its positive opinion on clinical data obtained from a single-arm, open-label Phase II trial performed in the US.

Janssen UK Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy director Jennifer Lee said: “This rare form of blood cancer has for too long been without a standard of care treatment, and ibrutinib is a real step-change in the management of WM.

"Ibrutinib is a real step-change in the management of WM."

“The decision to make ibrutinib available on the CDF makes it possible for additional clinical data to be collected to add to the evidence base for WM.”

NICE also issued an appraisal consultation document (ACD), recommending the firm to not use Imbruvica for adults with relapsed or refractory mantle cell lymphoma (MCL).

The institute said that the proposal for inclusion in the CDF will be considered and the drug will continue to be available on the previous CDF.

Responding to ACD, Jennifer Lee added: “This is particularly discouraging news for patients with MCL in the UK, as the medicine is already routinely available to patients with the same condition in Scotland, following the Scottish Medicines Consortium (SMC) recommendation last year.

“Should this guidance become final, UK patients with MCL could be left without access to this standard of care for the condition and with few treatment options, and none beyond chemotherapy.”