Astellas vs. MSD: Split Over Keytruda + Padcev Reimbursement

A difference in strategy has emerged between MSD Korea and Astellas Korea regarding the reimbursement process for the Keytruda + Padcev combination therapy, now positioned as a first-line treatment for locally advanced or metastatic urothelial carcinoma.

Astellas Korea resubmitted its reimbursement application for Padcev in late May—just three months after its initial attempt was rejected by the Serious Disease Reimbursement Review Committee in February.

The Keytruda + Padcev combination has garnered attention as the first new first-line therapy for metastatic urothelial carcinoma in three decades. At ESMO 2023, the regimen showed significant improvements in overall survival (OS) and progression-free survival (PFS), which were further confirmed in Asian subgroup analyses presented at ESMO Asia 2024. In the EV-302/KEYNOTE-A39 trial, the combination reduced the risk of death by 66% compared to chemotherapy (HR 0.34; 95% CI: 0.18–0.65), demonstrating statistically significant OS benefits.

Industry experts believe Astellas is strategically positioning Padcev as part of a first-line regimen, rather than limiting its use to second- or third-line settings. Currently, platinum-based chemotherapy remains the standard first-line treatment in Korea, with Bavencio (avelumab) reimbursed only as maintenance therapy.

An Astellas spokesperson stated, “We’ve submitted comprehensive data supporting the clinical value of this combination therapy. Given that metastatic urothelial cancer patients in Korea still begin treatment with therapies developed 30 years ago, we are committed to accelerating access to innovative options.”

In contrast, MSD Korea remains cautious. The company noted it must complete reimbursement negotiations for existing Keytruda indications before pursuing new ones.

“Of the 17 Keytruda indications submitted in February, 11 have been approved for reimbursement,” said an MSD representative. “Expansion to first-line urothelial carcinoma will be considered only after those processes conclude.”

Some in the industry point to regulatory barriers as a complicating factor. Under Korea’s Fair Competition and Trade Rules, pharmaceutical companies are prohibited from jointly discussing reimbursement strategies, including pricing and application timing. This constraint hinders coordinated efforts for combination therapies developed by different firms—despite such therapies becoming increasingly common.

“Authorities expect alignment on reimbursement, but the rules prevent inter-company collaboration,” said one industry insider. “To better reflect global trends, exemptions for combination therapies should be considered. Without reform, reimbursement for innovative combinations will continue to face delays.”

Others suggest more flexible approaches, such as partial reimbursement or increased patient cost-sharing, could offer practical interim solutions.

A representative from a multinational pharmaceutical firm commented, “While these options may not affect the criteria at the review committee level, they could help during pricing discussions with the Drug Reimbursement Evaluation Committee. At this stage, enabling first-line access is the top priority.”