'Brukinsa' aims to obtain CLL reimb for all age groups

Has submitted an application to expand the criteria for patients under the age of 65

There are limited treatment options besides conventional chemoimmunotherapy regimens, such as FCR

Product photo of BTK inhibitor 'Brukinsa'

The second-generation BTK inhibitor 'Brukinsa' aims to expand its prescription areas to all age groups in the chronic lymphocytic leukemia (CLL) treatment.

According to industry sources, BeOne Medicines Korea recently submitted an application to expand national health insurance reimbursement for Brukinsa (zanubrutinib). The application details include the first-line treatment of treatment-naïve CLL adult patients under the age of 65 who present with co-morbidities.

Consequently, it is noteworthy to watch whether this strategy will successfully improve the treatment paradigm for CLL patients under 65. These age groups have been relying on conventional chemoimmunotherapy regimens such as FCR (fludarabine·cyclophosphamide·rituximab).

While chronic lymphocytic leukemia is the most prevalent leukemia subtype in Western countries, it is a relatively rare disease in South Korea. Although reported figures vary across literature, the prevalence in South Korea is reported to be approximately 10 to 20 times lower than that observed in Western populations. This low disease prevalence is a shared epidemiological characteristic documented across East Asia, including Japan.

A distinct clinical feature characterizing South Korean CLL patients is the age group. In Western cohorts, the median age at diagnosis typically falls in the 70s, whereas numerous domestic studies report a significantly lower median age of around 60 years, ranging from 60 to 65 years. Consequently, a substantial proportion of South Korean patients are diagnosed at a relatively younger age; in several cases, the under-65 patient group is reported.

Brukinsa is currently recommended as Category 1 for the first-line treatment of CLL under the National Comprehensive Cancer Network (NCCN) Guidelines. Globally, it is being recommended as a primary treatment option without age-based restrictions.  

However, in South Korea, national health insurance reimbursement for Brukinsa is strictly limited to CLL patients aged 65 and older. Analysis suggests that this restrictive indication was established because Brukinsa's reimbursemnt  has been tied to the listed indication set by the first-in-class BTK inhibitor, 'Imbruvica (ibrutinib)'.  

Both health professionals and patients have consistently pointed out the current situation and called for expanding Brukinsa's reimbursement criteria in the CLL treatment.

Meanwhile, the clinical efficacy of Brukinsa in CLL was confirmed through the global Phase 3 SEQUOIA trial. This study evaluated patients with CLL or small lymphocytic lymphoma (SLL) who has no prior treatment history, comparing Brukinsa directly with a combination therapy of 'Symbenda (bendamustine)' + 'MabThera (rituximab)'.

The study results showed that at 24-month, the primary endpoint of progression-free survival (PFS) was 85.5% in the zanubrutinib group versus 69.5% in the bendamustine + rituximab control group. Furthermore, Brukinsa demonstrated a substantial 58% reduction in the risk of disease progression or death compared to the active control group.