BeiGene has shared that the National Institute for Health and Care Excellence (NICE) has recommended Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinemia (WM) in adult patients who have had at least one treatment, and only if bendamustine plus rituximab is also suitable.
NICE issued a final appraisal document (FAD) for the treatment, making Brukinsa the first and only available treatment option for WM to be recommended for routine use in England and Wales. Moreover, NICE’s decision marks Brukinsa as the first Bruton’s tyrosine kinase (BTK) inhibitor to be recommended as a routine treatment for WM.
WM is a rare type of B-cell lymphoma that occurs in less than 2% of patients with non-Hodgkin lymphomas and typically affects older adults.
WM is primarily found in bone marrow, though it can also present in the spleen and/or lymph nodes. It is estimated that around 4,000 people live with the condition in the UK and, for reasons yet to be established, WM is almost twice as common in men as in women and also occurs more often in Caucasians than in other ethnic groups.
NICE recognised the high unmet medical need for an effective and well tolerated treatment for WM ‘where current chemoimmunotherapy options can cause severe adverse reactions and the need for frequent hospital visits’ and summarised that Brukinsa could be ‘a step-change’ in disease management.
This is because the clinical evidence outlined that patients with WM may live longer and have a better quality of life with Brukinsa, compared to standard of care. The NICE recommendation states that Brukinsa is considered cost-effective at a threshold of £20,000-30,000 per quality-adjusted life year (QALY).
“I am very pleased that NICE has agreed that BRUKINSA is a valuable treatment option for eligible WM patients in England and Wales, enabling those patients to be among the first patients in Europe to have access to BRUKINSA,” commented Dr Robert Mulrooney, BeiGene general manager, UK and Ireland.
He added: “BeiGene’s mission is to achieve affordable access to our innovative medicines and we look forward to working with NICE and the National Health Service in the UK to create further treatment options for UK patients with blood cancers.”