Liver cancer therapy, ‘Stivarga’ set for 2nd RSA renewal

It was first listed In June 2016 as reimbursable under RSA for treating GIST...In 2020, Stivarga was successfully renewed for the first time

Stivarga.

It has been reported that a risk sharing agreement (RSA) has been renewed for the second time for Stivarga (regorafenib; Bayer Korea), a second-line treatment for liver cancer.

 

The news comes two months before the reimbursable RSA contract for Stivarga is set to expire on May 31st.

 

According to industry sources on the 18th, the National Health Insurance Service (NHIS) agreed to renew a RSA with Bayer for Stivarga.

 

Under the RSA, Stivarga is expected to receive reimbursement for five years until May 2029.

 

Stivarga was first listed In June 2016 as reimbursable under RSA for the first time for treating gastrointestinal stromal tumor (GIST).

 

Then, since May 2018, it has been reimbursable through RSA for a second-line treatment for hepatoma.

 

In May 2020, Stivarga successfully received the first contract renewal.

 

The contract duration is four years until May 31st, 2024.

 

At the time of the first renewal, Stivarga’s list price was reduced by 7%.

 

After the price cut in January 2022, the current maximum list price is KRW 303,868.

 

It has not been confirmed whether it will receive a price cut in the list price in this contract renewal.

 

However, it is anticipated that there will be a change in the actual price.

 

Stivarga is a second-line treatment for liver cancer, used after Nexavar, the first-line treatment.

 

Its out-patient prescription amount was KRW 9.3 billion won, down 24% from the previous year.

 

Overall sales of existing targeted anticancer therapies are slowing down as immunotherapy with reimbursement emerged.

 

According to Real World Data, which involved 182 Asian patients (Korea, China, and Taiwan), median Overall Survival (OS) with Stivarga was 16.3 months, an improvement of about 54% compared to the previous Phase 3 clinical study, ‘RESORCE.’