NICE Recommends BeiGene’s BRUKINSA (zanubrutinib) for Patients with Waldenström’s Macroglobulinemia who have had at Least One Treatment

BeiGene announced that England’s health technology assessment institute, the National Institute for Health and Care Excellence (NICE), has issued a final appraisal document (FAD) recommending BRUKINSA (zanubrutinib) for the treatment of Waldenström’s Macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable.

This decision from NICE marks BRUKINSA as the first and only treatment for WM to be recommended for routine use in England and Wales. The NICE Committee acknowledged the high unmet 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”.

WM is a rare form of B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomas. There are around 4,000 people living with WM in the UK.

“BRUKINSA is a highly selective BTK inhibitor,” said Dr Shirley D’Sa, consultant hematologist and clinical lead at the University College London Hospitals Centre for WM and Associated Disorders. “NICE’s positive recommendation for zanubrutinib allows eligible patients in England and Wales to access an important new treatment option that may offer improved outcomes compared to the current standard of care.”

In its appraisal, NICE concluded that zanubrutinib could be considered “a step-change” in managing the disease as clinical evidence suggests that people with WM may live longer and have a better quality of life with zanubrutinib 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 have 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. “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.”