"Multiple myeloma is a cancer type that has a great ripple effect depending on new drugs provided in a certain environment. Reimbursement of multiple myeloma treatment requires discussion following a thorough evaluation of the impact of the treatment depending on the treatment environment."

Multiple myeloma is one of the cancer types with increased treatment options following new drug entries.

There are concerns about extending the relapse period and progression-free survival (PFS) as the number of treatments increases due to relapses.

However, the discussion for reimbursement is hindered by cost issues. Youngil Koh, Professor of the Department of Hemato-Oncology at Seoul National University Hospital, emphasizes the importance of discussing appropriate disease-specific environments.

According to Koh, the development of new drugs for blood cancers is active because of disease characteristics.

Because cancer cells tend to exist in the blood and it is easy to obtain samples, the research is relatively simple. Understanding of blood cancer yields significant results compared to solid cancers.

"Almost all new drugs begin from blood cancers, including TKI, therapeutic antibody, bispecific antibody, and ADC, and expand to solid cancers. Bispecific antibodies and ADCs are used as the standard treatment for blood cancers and expand their indications to solid cancers," Koh said.

In South Korea, a bispecific antibody treatment, Tecvayli (teclistamab), is available for treating multiple myeloma. This drug was approved in July.

The use of Tecvayli is limited because it is not reimbursed, but the expansion of market presence is expected following the announcement of long-term follow-up research results of the drug's clinical trial, MajesTEC-1, at the American Society of Clinical Oncology (ASCO 2024) meeting.

The results of evaluating the efficacy of Tecvayli in 165 study participants at 30.4 months interim follow-up showed that Tecvayli reduced tumor sizes by 63% (overall response rate, ORR) in patients who had failed or were non-responsive to third-line treatments or higher.

46.1% of the patients reached complete remission (CR). The study confirmed consistent, long-term clinical effectiveness and positive safety profile.

"The 30-month follow-up outcome did not differ from the data presented in 2022; therefore, it is significant that we have confirmed the anticipated outcome," Koh said. "Specifically, 4 out of 10 patients showed great responses and maintained response over two years."

"We have observed that the real effects observed in 30-50 patients administered with the drug at the Seoul National University Hospital did not differ greatly from the research," added Koh. "1/3 of the patients benefited from the treatment, and close to half experienced great responses."

In conclusion, Koh says that the result should be highly regarded because Tecvayli's long-term follow-up data demonstrated that patients showed a significantly long response period after almost two-years of treatment.

Will Tecvayli, demonstrating its long-term effects, be adminstered earlier in the treatment course?

Based on the assumption that there are no differing opinions about the effect of Tecvayli, the question is 'when' to use the drug.

There are concerns about using the good drug first or last, regardless of disease. However, multiple myeloma requires a more careful approach because the treatment order is particularly important.

Koh says it is difficult to determine at this point, but Tecvayli is likely to be placed earlier in order since the data supporting its use of Tecvayli in earlier treatment course are now available.

"Tecvayli is the only bispecific antibody to be used for the treatment of multiple myeloma in South Korea and it targets BCMA, which the conventional treatments haven't targeted," Koh said.

"Based on the clinical data of Tecvayli used in combination with already effective treatments that are currently used, Tecvayli is likely to be employed earlier in the treatment and will be able to extend overall survival," Koh said.

However, Koh assessed that it is too early to mention whether bispecific antibody, known as the next-generation treatment, or CAR-T therapy should be placed earlier.

"The positions of bispecific antibody and CAR-T for treating multiple myeloma have not been established yet. We now know that two treatments successfully treat multiple myeloma, but it is early to determine which one is superior. Upcoming clinical data will determine their positions," Koh emphasized.

"Multiple myeloma is highly dynamic…changes to reimbursement strategy should be considered"

Besides the Tecvayli effect, the dilemma for new drugs is the cost. Patient burden increases when high-cost drugs are not covered by reimbursement.

Since multiple myeloma treatment tends to use 2-3 treatments in combination, the government is hesitant to opening the door to reimbursement.

Regarding this issue, Koh advises that rather than simply comparing the cost of the drug, a reimbursement strategy reflecting the characteristics of multiple myeloma should be discussed.

"The dynamic of treatments for multiple myeloma is changing due to new drugs, and the disease is greatly influenced by the type of new drugs and the type of reimbursement. We need to discuss reimbursement after anticipating the potential impact of reimbursement on overall treatment outcomes," Koh explained.

"The landscape of multiple myeloma is diverse and constantly changing; therefore, instead of simply comparing costs, the government can strategize better reimbursement plan taking into account various outcomes," Koh said.

Koh stated that we need to discuss patient access to clinical trials while reimbursement for new drugs is limited.

"New drugs are being developed faster than the reimbursement process. It is inevitable that patients cannot benefit from new drugs because reimbursement cannot cover all," Koh said. "In other words, drugs are available at clinical stages, so we could discuss increasing patient access to new drugs."