Onivyde listed at ₩672,320 as RSA refund type

Passed the Health Insurance Policy Deliberative Committee meeting…to be listed for benefit on August 1st

Servier Korea’s 'Onivyde injection(irinotecan liposome),’ which is used in second-line or higher treatment of pancreatic cancer, will be available with insurance benefits at ₩672,320 per vial starting next month.

 

The Ministry of Health and Welfare announced today(23rd) that the Health Insurance Policy Deliberative Committee deliberated and passed the ‘amendment to the drug benefit list and the maximum ceiling price table’ containing the amendment mentioned above.

 

The drug was approved by the Ministry of Food and Drug Safety as a ‘second-line treatment for metastatic pancreatic cancer,’ on August 29th, 2017.

 

In the same year, the company applied for its reimbursement to HIRA, on October 31st.

 

Although HIRA had held a Review Committee for Cancer Disease meeting to review its reimbursement on January 24th, 2018, the company withdrew its application in June, putting a stop to all discussions.

 

On July 24th, 2020, the company reapplied for the insurance benefit listing.

 

On April 8th of this year, HIRA held a Review Committee for Cancer Disease meeting and ruled that the drug is appropriate for reimbursement.

 

At the time, the committee recognized that the clinical practice guidelines then had recommended Onivyde in combination with fluorouracil and leucovorin for patients whose disease had progressed after first-line cancer therapy and that Onivyde had an improved clinical benefit compared to the control group in clinical studies.

 

Academic societies had also suggested compared to existing second-line treatments for pancreatic cancer that lacked evidence on their clinical usefulness, Onivyde had demonstrated its benefit through clinical studies and is being recommended as a preferred option in clinical practice guidelines for pancreatic cancer.

 

Afterward, the government ordered pricing negotiations to NHIS, and the NHIS made negotiations with the company from April 23rd to June 21st.

 

Among the A7 countries, the drug is currently listed in four countries - Japan, Germany, the United Kingdom, and the United States, and the A7 adjusted average price of Onivyde is ₩1,562,643.

 

Based on the price, the company and the NHIS had drug negotiations with the company to reimburse Onivyde as a refund type under the RSA scheme.

 

The refund type is a type of RSA agreement where the company refunds a certain proportion of the claimed drug cost.

 

In consideration of the fiscal impact and the foreign drug price, the NHIS and the company agreed to set Onivyde’s price at ₩672,320 per vial starting next month.

 

Through the reimbursement, approximately ₩12.1 billion of NHI finances is expected to be spent on Onivyde.

 

Additional finances spent due to the nonavailability of an alternative drug are estimated to be approximately ₩9.6 billion.