Janssen’s Imbruvica (ibrutinib) and BeiGene’s Brukinsa (zanubrutinib), the two BTK (bruton tyrosine kinase) inhibitors with the same mechanism, received two different review results from the Health Insurance Review and Assessment Service’s (HIRA) cancer drug reimbursement review committee.

The review panel granted expanded reimbursement for the first-generation BTK inhibitor, Imbruvica, as the first-line monotherapy to treat chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

In contrast, the second-generation BTK inhibitor, Brukinsa, failed to get the panel’s green light for insurance benefits for monotherapy in adult patients with mantle cell lymphoma (MCL) who had received at least one type of treatment.

More specifically, HIRA said Janssen’s Imbruvica was eligible for reimbursement as monotherapy in treatment-naive CLL/SLL patients aged 65 or more with comorbidities. For Janssen, it was a fourth challenge to get the reimbursement for that indication.

HIRA included the Imbruvica reimbursement issue in the review panel’s agenda three times between October 2021 and June 2022 but the panel rejected it every time.

The reimbursement of Imbruvica as the primary treatment for CLL/SLL has long been a long-cherished dream of patients and doctors in Korea.

Imbruvica was already reimbursable as monotherapy for relapsed or refractory CLL but the use as the first-line therapy was not, while that was the standard therapy in other countries.

Janssen now has to undergo the review of the Drug Reimbursement Evaluation Committee, complete drug price negotiations with the National Health Insurance Service, and get the final ruling of the Health Insurance Policy Review Committee to receive the expanded reimbursement for Imbruvica.

BeiGene, on the contrary, could not get the reimbursement for Brukinsa as monotherapy in adult patients with mantle cell lymphoma (MCL) who have received at least one type of treatment.

It was a second rejection after the panel did not pass the reimbursement for such indication of Brukinsa in April.

At the time, Brukinsa won reimbursement only as monotherapy in adult patients with Waldenstrom's macroglobulinemia (WM) who had previously received at least one type of treatment.

This time, BeiGene updated data to get insurance benefits for MCL again.

An industry source said BeiGene had put on hold applying for evaluation of Brukinsa’s WM indication to the Drug Reimbursement Evaluation Committee, in order to receive benefits for both indications.

With the failed attempt to get MCL reimbursement, attention is on whether BeiGene will revise its strategy regarding insurance benefits for Brukinsa. 

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