'Padcev Combination therapy' has been reported to have changed the urothelial cancer treatment paradigm after 30 years.

After its launch in clinical practices in South Korea in the second half of last year, the government has initiated discussion for reimbursement of the therapy.

According to the pharmaceutical industry on February 17, the Health Insurance Review and Assessment Service (HIRA) recently held the first Cancer Disease Review Committee (CDRC) for this year and discussed setting the reimbursement standards for the combination therapy containing Padcev (enfortumab, Astellas Pharma Korea) and Keytruda (pembrolizumab, MSD Korea).

Padev was launched and became available for prescription in South Korea last year. It is an ADC anticancer agent for treating patients with metastatic urothelial carcinoma who failed previous treatments. In July 2024, indications were expanded as a first-line treatment in combination with Keytruda. Thus, Padcev is now an ADC anticancer agent approved for use in first-line to third-line treatments for metastatic urothelial carcinoma.

Domestic approval was based on the EV-302 clinical study presented during the 2023 Congress of the European Society for Medical Oncology (ESMO Congress 2023). EV-302 is a randomized Phase 3 clinical study evaluating the effectiveness of Padcev+Keytruda combination therapy compared to platinum-based chemotherapy in 886 patients in 25 countries.

Based on the study, at the median follow-up of 17.2 months, patients treated with Padcev combination therapy had a median overall survival (OS) of 31.5 months, extending the OS by approximately twofold compared to the platinum-based chemotherapy group and reducing death risk by 53%.

The median progression-free survival (mPFS) of the combination therapy group was 12.5 months, and the mPFS of the platinum-based chemotherapy group was 6.3 months. The Padcev combination therapy extended the mPFS by approximately twofold.

Based on this result, Astellas Pharma applied for reimbursement to the HIRA at the end of last year, and it has been considered for the first CDRC review for this year.

However, the drug failed to pass the CDRC review after receiving the decision of 'reimbursement standards non-established.'

Interestingly, Astellas Pharma had applied for reimbursement alone and its application was considered for the CDRC review.

In the past, the review would have required applying for reimbursement with the Keytruda owner MSD. The policy has changed based on the global pharmaceutical companies' headquarters policy and the domestic‧foreign Fair Trade Act, and discussion with another pharmaceutical company can be considered 'price fixing.'

As for Keytruda, which is used along with Padcev, MSD has not applied for reimbursement. It has been reported that MSD has applied for 17 indications, so the company may have been reluctant to file an additional one.

However, the pharmaceutical industry believes that HIRA's approach toward combination therapies may have changed after the decision on the Padcev combination therapy.

At the end of last year, HIRA announced the establishment of a review policy for reimbursement decisions on combination therapies.

A pharmaceutical industry employee said who asked for anonymity said, "Last year, the CDRC review established a review policy for deciding on the reimbursement of combination therapies. However, the policy was limited to cases where a new drug is added to a previously reimbursed drug." He added, "The review of Padcev combination therapy indicates that an approach towards new drugs can be changed."