South Korea will cover a combination therapy pairing new drugs from two different pharmaceutical companies under national health insurance for the first time. With coverage granted to the urothelial cancer treatments Padcev and Keytruda, attention is turning to whether other combinations, such as Leclaza and Rybrevant, can clear the same bar.
The Ministry of Health and Welfare said on the 30th that national health insurance will cover the combination of Astellas Pharma Korea's Padcev and MSD Korea's Keytruda as a first-line treatment for locally advanced and metastatic urothelial cancer starting Oct. 1. Padcev delivers a cancer-fighting agent by targeting tumor cells, while Keytruda works by helping immune cells attack them. In a key clinical trial, median overall survival for patients on the combination was 31.5 months, roughly double the 16.1 months for patients who received conventional chemotherapy. Until now, however, Keytruda was reimbursed only from second-line treatment onward, after a first-line therapy had failed, limiting treatment options for patients.
The decision draws attention because it is effectively the first case of insurance coverage for a combination of new drugs held by different pharmaceutical companies. The ministry said it plans to use the case as a basis for rule changes aimed at expanding insurance coverage of combination therapies.
That has drawn industry interest to possible coverage for the combination of Yuhan's lung cancer drug Leclaza and Janssen Korea's Rybrevant. Leclaza is an oral targeted cancer drug that blocks tumor growth signals, while Rybrevant is an antibody treatment that simultaneously targets two proteins involved in cancer growth. The combination has been approved in South Korea as a first-line treatment for non-small cell lung cancer with either an exon 19 deletion or an exon 21 substitution mutation in the epidermal growth factor receptor (EGFR) gene. Leclaza is currently reimbursed even when used in combination, but Rybrevant is not covered, which industry watchers say has limited the spread of prescriptions. Patients pay about 1.8 million won a year for Leclaza, while Rybrevant is said to cost between 150 million and 160 million won.
From October, Rybrevant will be reimbursed only as a monotherapy in second-line or later treatment of lung cancer with an EGFR exon 20 insertion mutation. Its first-line combination with Leclaza is not included in this round of coverage because the patient group and treatment stage differ. The combination previously failed twice to win reimbursement criteria from the Cancer Disease Review Committee.
An official at Janssen Korea said the company "plans to actively work toward insurance coverage for other Rybrevant indications as well." The company also said it will continue procedures for a swift rollout, including filing for domestic approval of a subcutaneous (SC) formulation of Rybrevant.
