Tibsovo finally receives DREC review for reimbursement

Likely to receive review on July 2nd… flexible application of the ICER threshold key to reimbursement

Introduction of this novel IDH1-targeted therapy in cholangiocarcinoma, which lacks treatment options, gains attention.

Tibsovo, a novel therapy for cholangiocarcinoma for which reimbursement has remained stalled for more than a year, is finally set to clear the last hurdle of the Health Insurance Review and Assessment Service (HIRA).

According to Dailypharm coverage, Servier Korea's IDH1-targeted therapy Tibsovo (ivosidenib) for patients with IDH1 mutation-positive cholangiocarcinoma will be reviewed by HIRA's Drug Reimbursement Evaluation Committee (DREC) on July 2.

Tibsovo was first approved as an orphan drug in Korea in April 2024. After passing the Cancer Drug Deliberation Committee on its second attempt in April 2025 for the cholangiocarcinoma indication, the product has spent more than a year under pharmacoeconomic evaluation.

Recently, the government announced plans to improve access to innovative medicines for severe and rare diseases by raising the acceptable ICER threshold and revising the evaluation framework to better reflect disease severity and therapeutic value. As a result, whether Tibsovo will receive a flexible ICER application is expected to be the key issue at the upcoming reimbursement committee meeting.

Cholangiocarcinoma is a representative high-risk cancer. Korea is known to have the world's highest mortality rate from biliary tract cancer, while the five-year survival rate for metastatic disease is only 4.1%. In the pivotal ClarIDHy trial, which served as the basis for the approval of Tibsovo, the median overall survival (mOS) of the control group was just 5.1 months.

Its treatment landscape has recently improved somewhat in recent years. In the first-line setting, the 'Imfinzi (durvalumab)' combination therapy, and for second-line treatment, 'Pemazyre (pemigatinib)' for patients with FGFR2 fusion and 'Keytruda (pembrolizumab)' for MSI-H/dMMR patients have been granted reimbursement in Korea.

However, patients with IDH1 mutations still have no reimbursed targeted treatment option, leaving a significant therapeutic gap.

The socioeconomic burden of the disease is also substantial. Because cholangiocarcinoma is difficult to detect early, many patients are diagnosed at an advanced stage. Experts note that disparities in treatment access driven by socioeconomic status directly translate into disparities in survival rates in the disease.

In the Phase III ClarIDHy trial, Tibsovo improved median overall survival to 10.3 months, nearly doubling survival compared with 5.1 months in the placebo group (HR 0.49). Median progression-free survival (PFS) also improved significantly to 2.7 months, versus 1.4 months with placebo. Based on these results, Tibsovo became the only second-line treatment for cholangiocarcinoma to receive a Category 1 recommendation in the NCCN Guidelines.

More recently, findings from the Phase IIIb real-world ProvIDHe study also drew attention. Median overall survival reached 15.5 months in the overall study population, while the Korea-Australia subgroup, which included Korean patients, reported an mOS of 19.7 months.

Meanwhile, Tibsovo has received reimbursement recommendations in seven of the eight A8 countries. The UK's NICE concluded cholangiocarcinoma is a severe condition as patients lose most of their expected life expectancy and quality of life, and applied the maximum severity modifier of 1.7. Scotland's SMC and Australia's PBAC also recommended reimbursement, citing the high unmet medical need and lack of alternative therapies.