Astellas Pharma has set about to rectify the reimbursement track for Xtandi (enzalutamide), its prostate cancer treatment that caused confusion in the clinical field by receiving selective reimbursement for the same indications differently from competitor drugs.

Astellas recently submitted an application for Xtandi’s essential reimbursement to Health Insurance Review and Assessment Service (HIRA).

Last August, Xtandi received expanded reimbursement for treating metastatic hormone-sensitive prostate cancer (mHSPC) patients combined with androgen deprivation therapy (ADT).

Xtandi received approval from the Ministry of Food and Drug Safety to treat metastatic castration-resistant prostate cancer (mCRPC) patients for the first time in June 2013. It was then registered as subject to essential reimbursement through a risk-sharing agreement (RSA) in November 2014.

However, Xtandi’s reimbursement expansion to mHSPC has been set at the selective reimbursement (30/100), considering that Janssen’s Zytiga (abiraterone) also received selective reimbursement for treating high-risk mHSPC.

However, Erleada, which won applications for treating mHSPC patients from the ministry for the first time in late 2020, was registered on the insurance list through the general reimbursement track. Accordingly, patients who use Erleada had only to pay 5 percent of drug costs thanks to special calculation cases for cancer disease.

Confusion occurred in the clinical field as two drugs with similar efficacy on the same patient groups received different reimbursements, with a widely different patient burden ratio of 30 percent and 5 percent.

Patients who use Xtandi must pay about 750,000 won ($560) a month, but those using Erleada have only to pay about 120,000 won monthly.

Therefore, concerns arose over confusion in the clinical field from late March when Erleada was about to receive insurance benefits. Astella, which sold Xtandi, immediately applied for a shift to essential reimbursement to rectify the confusion.

However, confusion will likely among patients who use the two drugs.

That’s because now that Xtandi has applied for essential reimbursement, it must undergo all existing reimbursement procedures to be registered on the list anew.

Astellas is waiting for its application to be tabled at the meeting of the cancer disease deliberation committee, the first threshold for reimbursement after submitting its application.