Can we expect Darzalex to receive expanded reimb this year?

The first-and second-line combination therapies expected to be considered for the Drug Reimbursement Committee

After receiving the expanded indication, the discussion for listing has been delayed

Janssen Korea’s Darzalex (daratumumab).

A multiple myeloma drug, ‘Darzalex,’ garners attention as to whether it could receive expanded use this year.

 

Janssen Korea’s Darzalex (daratumumab) is under discussion for expanding reimbursement into multiple indications.

 

It is categorized into two types of therapies.

 

The first is the DVTd (daratumumab, bortezomib, thalidomide, and dexamethasone) combination therapy, which cleared the Cancer Drug Review Committee of the Health Insurance Review and Assessment Service (HIRA) last May as the first-line treatment of multiple myeloma.

 

Another is a combination therapy, including DRd (daratumumab, lenalidomide, and dexamethasone), DVd (daratumumab, bortezomib, and dexamethasone), and DKd (daratumumab, carfilzomib, and dexamethasone), for second-line treatment, which passed the first review of the year by the Cancer Drug Review Committee.

 

There has been a long-standing demand for hospitals to use combinations indicated for the first- and second-line treatments.

 

However, the process of expanding reimbursement has been delayed until now.

 

These expanded indications were approved in Korea in 2019.

 

However, patients must pay 100% out-of-pocket expenses for Darzalex, except when receiving it as ‘Monotherapy of fourth-line treatment or more in patients with recurrent and refractory disease who have received three or more types of treatment, including PI inhibitors and immune inhibitors.” Although the Cancer Drug Review Committee approved the combination strategy as a second-line treatment in January, the drug has not been considered for review for almost 10 months due to unestablished reimbursement criteria last March.

 

Therefore, it remains to be seen whether the indications that have passed the Cancer Drug Review Committee will receive reimbursement from the 2024 Drug Reimbursement Committee review.

 

Currently, the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) recommend the Darzalex combination as standard therapy for first and second-line treatments.

 

They also recommend the use of DVTd four-drug combination for first-line treatment in patients who are eligible for hematopoietic stem cell transplantation.

 

Darzalex’s active ingredient daratumumab is a human monoclonal antibody that targets ‘CD-38,’ a cell surface protein that is overexpressed on multiple myeloma cells.

 

This drug can directly induce cancer cell death through several underlying mechanisms, including the following: ▲Complement-dependent cytotoxicity (CDC), ▲Antibody-dependent cell-mediated cytotoxicity (ADCC), and ▲Antibody-dependent cellular phagocytosis (ADCP).