With Janssen Korea reapplying to extend the reimbursement of its Darzalex (daratumumab), which it first failed at the Drug Reimbursement Evaluation Committee’s stage, whether the company will succeed in making progress in its discussions this time is gaining attention.


According to industry sources on the 4th, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee will deliberate on the adequacy of Dazalex's reimbursement on the 10th.

At the center of the discussion is the DVTd regimen (Darzalex+bortezomib+thalidomide+dexamethasone), which is used as a first-line treatment for multiple myeloma in practice.

In the previous review, DREC concluded the ‘reimbursement extension adequacy unclear’ for the DVTd regimen. This is contrary to the conclusion reached by the Cancer Disease Deliberation Committee in January, which acknowledged the need to set reimbursement standards for the DVTd regimen.

In this context, ‘unclear’ means that it is not adequate to extend the reimbursement standard, putting on hold the reimbursement extension process.

However, HIRA stated that the company may reapply for redeliberation. In response, Janssen Korea has reportedly reapplied for DREC’s redliberations.

Multiple myeloma, which Darzalex is indicated for, is a typical blood cancer characterized by its long treatment period. As a first-line treatment, patients receive 6 months of induction therapy followed by about 2 months of autologous stem cell transplant preparation and transplantation, which rounds up to a total of 8 months.

In Korea, the 3-drug VTd regimen (bortezomib+thalidomide+dexamethasone) was first introduced as a first-line treatment, and then evolved to become the RVd regimen (lenalidomide+bortezomib+dexamethasone), which has since become the standard first-line treatment.

The DVTd regimen (Darzalex+bortezomib+thalidomide+dexamethasone) is a 4-drug regimen that adds Darzalex to the VTd regimen.

In fact, there has been a great need for the 4-drug regimen in clinical practice. Even if Korea’s treatment situation is not the same as those in other major countries such as the United States, the industry believes it should not be significantly different.

Youngil Koh, Professor of Hemato Oncology at Seoul National University Hospital, said, “The reimbursement extension of Darzalex is a very important issue in practice. It may not be easy for Korea to provide the same level of coverage for Darzalex as other countries such as the United States due to various conditions, but there shouldn’t be too much difference either.’

Professor Koh added, “‘Tree drugs are better than two drugs, and four drugs are better than three drugs in the initial treatment of multiple myeloma, so the message that adding Darzalex is better has been around for a long time. However, patients are not benefiting from its use due to lack of access to Darzalex as a combination therapy for multiple myeloma in Korea, either as first-line or second-line treatment.

The bottom line is that there is a significant reimbursement gap between the U.S. and Europe and the domestic reimbursement landscape, which needs to be addressed.

Darzalex accumulates long-term data…shows improved performance over the existing 3-drug regimen

The question is whether the DVTd regimen, which has already received a ‘reimbursement adequacy unclear’ decision from DREC, will be able to overturn this judgment during the second review.

For this, the company is likely to emphasize the adequacy of the reimbursement expansion based on the results of DVTd regimen study that was published this year.

The CASSIOPEIA study, which was presented at the European Haematology Association (EHA) Congress in June, compared the DVTd regimen followed by autologous stem cell transplantation to VTd regimen followed by autologous stem cell transplantation in newly diagnosed multiple myeloma patients who were candidates for stem cell transplantation. Study results showed that the benefit of adding Darzalex was significant.

At a median follow-up of 80.1 months, results showed a median progression-free survival of 83.7 months with the 4-drug regimen, compared to 52.8 months with the 3-drug regimen, a difference over 30 months.

This analysis demonstrates that as the first treatment option for newly diagnosed multiple myeloma patients, early, effective agents can prolong progression-free survival and improve overall survival.

The 7-year follow-up study results are particularly significant given that the 5-year relative survival rate for multiple myeloma is approximately 50% for both men and women.

However, Darzalex remains ‘non-reimbursed,’ and only the other 3 drugs - the VTd regimen -are currently covered, so it remains to be seen if the relatively expensive Darzalex will make its way onto Korea’s health insurance reimbursement plans.