Nexavar reimbursement cleared for severe HCC patients

GIDEON study confirms safety in treating Child-Pugh B7 patient group

From this year, reimbursed prescription would be granted on liver cancer treatment Nexavar treating patient with severe liver dysfunction.

 

According to the new pharmaceutical listing, reimbursement on Nexavar (sorafenib) would be provided for a patient, including pediatric patient, with advanced hepatocelluar carcinoma (HCC) who is unable to undergo local treatment like surgery or transarterial chemoemoblization (TACE), and qualifies condition of being classified as class A or B7 according to Child-Pugh scoring; in Stage III or more advanced; or classified as Grade 0 to 2 of ECOG Performance Status.

 

Provided by the newly revised listing, treatment access to Nexavar has been expanded not only for patients with good liver condition graded by Child-Pugh scoring, but also for patients with HCC with severe liver dysfunction.

 

The coverage expansion has been decided based on the safety profile confirmed in the GIDEON study incorporating HCC treatment guideline from home and abroad and numerous HCC patients classified in class B7 by Child-Pugh scoring.

 

With 3,371 participants around the world with unresectable HCC, GIDEON study evaluated safety of sorafenib by treating the subgroup patients with 800 mg of sorafenib daily, reduced when necessary.

 

The study found consistent safety profile in over 70 percent of the participants, specifically in Child-Pugh A patient group (61 percent) and Child-Pugh B7 patient group (11 percent).

 

Consistent incidences of adverse events were reported from Child-Pugh A and Child-Pugh B7 patients groups with 69 percent and 67 percent, respectively.

 

Commonly reported drug-related adverse reaction from Child-Pugh B7 group was diarrhea (27 percent), hand-foot syndrome (20 percent) and fatigue (16 percent).

 

And in the subgroup analysis of GIDEON on 482 Korean patients, the safety profile was consistent in Child-Pugh A patient group (56.8 percent) and Child-Pugh B patient group (21.8 percent).

 

The subgroup analysis found overall patient group treated with sorafenib (n=482), including Child-Pugh B patients, reached median overall survival of 8.5 months, which was not too far off from the median overall survival of 10.2 months in Child-Pugh A patients only group.

 

Commonly referred by cancer academics, the U.S.

 

National Comprehensive Cancer Network (NCCN) Guidelines (Version 3.2019) and HCC Treatment Guideline in Korea (2018) recommends Nexavar as systemic treatment for HCC patients with specific tumor condition including Child-Pugh A and B7 class of liver function.

 

Professor Kim Yoon Jun of Gastroenterology Department at Seoul National University Hospital commented, “Preserving the liver function is crucial in HCC treatment, but patients with already dysfunctional liver or cancer-damaged liver had not have many treatment option.

 

However, even the patients with severe liver condition, who used to be inaccessible to systemic anticancer therapy, can now access to higher level treatment option with expanded reimbursement.”