Livtencity received reimbursement since April. 1 2024

The giant cell virus (CMV) treatment drug, Livtencity tablets (maribavir) from Takeda Pharmaceutical, will be covered by health insurance starting from April 1st. It has been only about 1 year and 3 months since it received domestic marketing approval.

According to the Ministry of Health and Welfare on the 26th, CMV infection commonly occurs between 1 to 6 months after solid organ transplantation or bone marrow transplantation. In patients whose immune system is suppressed due to the use of immunosuppressants, the virus can reactivate, leading to CMV disease, which shows a high incidence of serious complications and mortality rates.

CMV is the most common and important virus that can adversely affect post-transplant outcomes. In Korea, the rate of CMV antibody positivity is very high, around 95-98% in adults starting from the age of 9.

Livtencity received domestic marketing approval in Korea on December 17, 2022, for use in the treatment of CMV infection and disease after transplantation in adult patients who have resistance or are unresponsive to ganciclovir, valganciclovir, foscarnet, or cidofovir.

The application for insurance coverage was made on January 31, 2023. Subsequently, the process for coverage proceeded relatively smoothly through the following steps: review by the Drug Reimbursement Review Committee on June 16 of the same year, economic evaluation review on August 18, risk sharing committee review on November 22, review by the Pharmaceutical Benefit Evaluation Committee on December 7 of the same year. Negotiations with the National Health Insurance Service (NHIS) were conducted for two months and concluded on February 26 this year.

Professional societies such as the Korean Society of Transplantation stated, "There are no therapeutically equivalent drugs within the insurance coverage. If there is no response to ganciclovir or valganciclovir, foscarnet or cidofovir may be used based on the clinical judgment of individual patients. However, all ganciclovir, foscarnet, and cidofovir may have cross-resistance due to the UL54 mutation, so Livtencity is considered the most useful drug to replace them."

The Drug Benefit Evaluation Committee acknowledged, "Significant improvements were observed in achieving the removal of CMV viremia by the 8th week compared to the comparator drug ganciclovir, therefore, clinical utility improvement is recognized, although the cost is high." However, they also stated, "It falls under the application scope of risk-sharing contracts, and considering the economic evaluation results of the risk-sharing contract type (refundable), severity of the disease, social impact, etc., the submitted cost-effectiveness ratio is acceptable, so it is considered appropriate for insurance coverage."

The number of countries where it is approved includes the United States, the United Kingdom, and Italy. The adjusted average price per patient is 262,320 KRW, and the lowest price (in the United States) is estimated to be 237,290 KRW.

In negotiations with the NHIS, an agreement was reached on a ceiling amount of 194,500 KRW and an expected claims amount of 15.3 billion KRW, taking into account the deliberation results of the Drug Benefit Evaluation Committee, status of reference countries, and budget impact. The maximu reimbursement price is approximately 81% of the lowest price among A8 countries.

The Ministry of Health and Welfare stated, "Currently, there are no drugs therapeutically equivalent to Livtencity. The annual financial requirement is estimated to be approximately 15.3 billion won, but considering risk-sharing contracts (refundable, total limit), the actual financial requirement is expected to be less than this."