Cancer & orphan drugs apply for reimb within 1 week of apv

4 anticancer drugs and 2 orphan drugs (excluding fast-track approval-evaluation-negotiation drugs) applied for approval and reimbursement within the year

GIFT-Designated ‘Fruzaqla, QalsoDy, Imdelltra’ enter reimbursement review phase

Opsynvi applies for reimb just one week after approval → cost-effectiveness review underway

Anticancer drugs and rare disease drugs that were approved in Korea this year are racing to apply for reimbursement as quickly as within a week.

 

Six rare/serious disease treatments approved by the Ministry of Food and Drug Safety this year are undergoing reimbursement review, excluding those subject to the approval-evaluation-negotiation system.

 

According to industry sources on the 7th, multiple new drugs, including those designated under the Global Innovative product on Fast-Track (GIFT) scheme, are applying for reimbursement quickly after approval.

 

Takeda Korea’s Fruzaqla (fruquintinib), which was approved in March for metastatic colorectal cancer, was submitted for reimbursement last month and is currently being assessed for clinical benefit.

 

The drug, designated GIFT No.

 

20, was specifically requested for expedited coverage during this year’s NA MOHW audit as a third-line therapy for metastatic colorectal cancer.

 

Qalsody (tofersen), Biogen’s amyotrophic lateral sclerosis (ALS) treatment and GIFT No.

 

31, received approval on August 20 and was immediately filed for reimbursement to expand its prescription.

 

Imdelltra (tarlatamab), Amgen Korea’s small-cell lung-cancer drug (GIFT No.

 

25), was approved on May 30 and submitted for reimbursement on August 28.

 

Augtyro (repoterrectinib), Bristol Myers Squibb’s therapy for metastatic non-small-cell lung cancer and solid tumors, followed a similar path — approved in June, filed 2 months later.

 

Gilead Sciences’ Yescarta (axicabtagene ciloleucel), a CAR-T therapy for diffuse large B-cell lymphoma, and Janssen Korea’s Opsynvi (macitentan + tadalafil) for pulmonary arterial hypertension, both received approval in July and August, respectively, and each applied for reimbursement within just 1 week of approval.

 

Opsynvi is now undergoing a cost-effectiveness evaluation.

 

Industry analysts attribute this accelerated pace partly to the current administration’s policy direction under President Jae-myung Lee, which emphasizes improving patient access to orphan and severe-disease treatments.

 

However, even with early reimbursement filings, such drugs typically face lengthy review cycles as significant time is required for clinical utility and cost-effectiveness reviews.

 

Even if they clear the threshold of proof, a protracted drug price negotiation process remains.

 

Currently, 33 drugs that applied for reimbursement last year and this year remain under review, suggesting fierce behind-the-scenes competition among drugs for priority listing.