Janssen Korea’s Zytiga secures expanded reimbursement for 1st-line prostate cancer treatment

Beginning in April, Janssen Korea's prostate cancer drug Zytiga will be available with prednisolone as a first-line treatment for patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), with the patient’s out-of-pocket payment reduced from 30 percent (selective reimbursement) to 5 percent.

Metastatic castration-resistant prostate cancer occurs when prostate cancer spreads to the bones or other organs and continues to grow despite lowered blood testosterone levels. Patients with this condition typically have a survival time of only two to three years.

Zytiga is a once-daily oral anti-cancer drug that inhibits the CYP17 (Cytochrome P450 17A1) enzyme complex, which is essential for androgen production. By blocking the androgen production pathway in testicular, adrenal, and prostate cancer cells, it helps slow disease progression. It is administered in combination with prednisolone.

Janssen Korea announced that, effective April 1, Zytiga will be reimbursed with a 5 percent co-payment for patients with metastatic castration-resistant prostate cancer who have an ECOG performance status (PS) of 0 or 1 and experience no or mild pain that does not require narcotic analgesics.

The reimbursement change for Zytiga is based on a phase 3 COU-AA-302 clinical study in patients with metastatic castration-resistant prostate cancer who have not undergone chemotherapy.

The study demonstrated superior clinical benefits in the Zytiga plus prednisone arm compared to the placebo plus prednisone arm.

In the COU-AA-302 study, median imaging progression-free survival was 16.5 months in the Zytiga combination arm compared to 8.2 months in the placebo arm after a median follow-up of 27.1 months, representing a nearly twofold improvement.

Over a median follow-up of 49.2 months, median overall survival (OS) in the Zytiga combination arm was 34.7 months compared to 30.3 months in the placebo arm, a 4.4-month extension. 

Hong Jun-hyuk, a professor of urology at Asan Medical Center, stated, "Zytiga is one of the first-line treatments for prostate cancer in clinical practice. This reimbursement change significantly reduces the financial burden on patients and enables healthcare providers to actively apply effective treatment options."

Kim Yeon-hee, Oncology Business and Rare Disease Unit Executive Director at Janssen Korea, added, "As a first-line treatment for patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer, we have been working hard to expand access to prostate cancer treatment since Zytiga's reimbursement in 2019. We are pleased to announce that the out-of-pocket cost for Zytiga has been reduced after five years."