Despite global recognition, high costs and limited real-world data hinder approval
Padcev (enfortumab vedotin) and 슬롯사이트 (zolbetuximab), emerging as next-generation first-line treatments for metastatic cancer, have faced a setback in Korea’s reimbursement evaluation. The Health Insurance Review and Assessment Service (HIRA) declined coverage for both drugs under the Severe Disease (Cancer) Review Committee, raising questions about the decision and the next steps for manufacturers.
At its first oncology review meeting of the year on February 12, HIRA assessed the two anticancer drugs from Astellas Korea but did not grant them a defined reimbursement standard. Despite their recognition for shifting the treatment paradigm at global conferences, experts suggest that factors beyond clinical utility played a role in the decision.
Padcev, in combination with Keytruda (pembrolizumab), is a first-line treatment for locally advanced or metastatic urothelial carcinoma. At the 2023 European Society for Medical Oncology (ESMO) congress, the Phase 3 ‘EV-302’ trial showed the combination reduced the risk of death by 53% compared to standard gemcitabine plus platinum-based chemotherapy, earning widespread acclaim.
슬롯사이트 is the first Claudin 18.2 (CLDN18.2)-targeting treatment for metastatic gastric cancer. The ‘SPOTLIGHT’ and ‘GLOW’ studies demonstrated that 슬롯사이트, combined with fluoropyrimidine and platinum-based chemotherapy, extended progression-free survival (PFS) by approximately two months and overall survival (OS) by two to three months compared to standard chemotherapy.
Both regimens have received Category 1 preferred therapy recommendations from leading oncology organizations, including the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN), and ESMO. Korea was among the first countries to introduce these treatments, with local patient data showing even better outcomes than global populations, further fueling interest in their adoption.
However, industry experts cite high drug costs, the complexity of combination therapies, and insufficient real-world data (RWD) as major hurdles in HIRA’s assessment. The Padcev-Keytruda combination, involving an antibody-drug conjugate (ADC) and an immune checkpoint inhibitor—both costly therapies from different pharmaceutical companies—adds further challenges.
For 슬롯사이트, while reimbursement for Claudin 18.2 diagnostic tests has been partially resolved, delays in clinical adoption have limited RWD, potentially influencing HIRA’s decision. Additionally, some speculate that the approval of reimbursement for 11 Keytruda indications in this review session signals a prioritization of cost-effectiveness over new drug adoption.
Astellas plans to supplement its data and reapply for reimbursement in future oncology review sessions.
“Both 슬롯사이트 and Padcev are crucial treatment options for metastatic cancer patients with limited alternatives. Expectations from physicians and patients are high, and we are actively communicating with HIRA to ensure a swift reapplication, reaffirming the necessity and clinical value of these therapies,” an Astellas representative stated.