Liver cancer pioneer ‘Nexavar,' the star in its guidelines

the only drug added for hepatocellular carcinoma in the guideline

Blockbuster anticancer drug | Episode 5: Nexavar

Had maintained its sole lead for over a decade… only drug recommended as first-line

Situation has changed with the introduction of competitor drugs… sales have decreased since patent expiry

There are two reasons why new drug development is slow for a certain disease: its marketability is low or the development of the drug is difficult.

 

When developed, new drugs developed in the latter situation attract more widespread attention.

 

Liver cancer (hepatocellular carcinoma) is a typical example of this.

 

And the only targeted anticancer therapy that was available in this difficult-to-develop field of liver cancer for over 10 years was ‘Nexavar (sorafenib).’ Of course, new drugs are now available, such as ‘Stivargar (regorafenib)’ as second-line treatment, and ‘Lenvima (Lenvatinib),’ which is used as first-line treatment like Nexavar.

 

Also, an immunotherapy option was added in the field with the approval of the ‘Tecentriq (atezolizumab)+Avastin (bevacizumab)’ combination therapy.

 

Still, Nexavar’s legacy remains strong ◆The liver treatment that was introduced for the first time in 30 years Nexavar, which was the first in the world to receive FDA approval for hepatocellular carcinoma, opened the door to targeted anticancer therapy in the field.

 

At the time, Nexavar was a significant achievement that was made after a series of attempts and failures by pharmaceutical companies for around 30 years.

 

In Korea, after receiving the first-ever approval for hepatocellular carcinoma from the Ministry of Food and Drug Safety in March 2008, the drug has accumulated the most amount of treatment experience as the only first-line targeted therapy for over a decade since then.

 

And the drug kept on evolving.

 

Data from the GIDEON study that was conducted on 3,371 liver cancer patients in 39 countries around the globe, the drug showed a consistent safety profile in Child-Pugh class B7 patients with liver damage (11%, n=359) and 에서 Child-Pugh class A patients (61%, n=1968).

 

Based on this, Nexavar is currently the only drug recommended as a first-line systemic anticancer therapy in patients with Child-Pugh class B7 in the 2020 NCCN guidelines (Version 5).

 

◆The significance of reimbursement approval in Child-Pugh class B7 and the rising position of Nexavar By succeeding to expand its insurance benefit, Nexavar once again strengthened its position in the field.

 

With Nexavar’s insurance benefit approved to Child-Pugh class B7 patients, or severe disease patients, the drug’s utility in liver disease has even more increased.

 

Before then, Child-Pugh class B7 was a sort of ‘grey area’ in the field of liver cancer.

 

With the approval, Nexavar can now be used with reimbursement in patients with advanced hepatocellular carcinoma (HCC, including pediatric patients) who cannot receive local treatment such as surgery or transarterial chemoembolization (TACE) that are: ▲Child-Pugh class A or B7; ▲at Stage Ⅲ or higher; or ▲ whose ECOG performance status (PS) is 0-2.

 

Also, the biggest advantage of the first-line treatment Nexavar is that it has a second-line treatment Stivarga available for use in sequence with reimbursement.

 

A clinical trial showed that the use of Nexavar in sequence with the second-line treatment Stivarga prolonged overall survival (OS).

 

However, limitations still exist as Nexavar is the only systemic anticancer treatment reimbursed for Child-Pugh class B7 patients, and no sequential treatment is available for use with reimbursement after Nexavar.

 

Also, there are unfavorable views on the limited reimbursement status of its competitor drug Lenvima.

 

◆Patent expiry, drug price cuts, and the entrance of competitor drugs However, in terms of sales, Nexavar is now on its descent.

 

It's not about the prescription amount, but about the patent expiry and the resulting drug price cut.

 

According to IQVIA, Bayer’s hepatocellular carcinoma treatment sold 5.6 billion won in the first half of the year.

 

This is a 45% decrease from the 10.3 billion won that was sold in 1H last year.

 

In the same period, sales of Eisai’s Lenvima increased 27% from 5.7 billion won to 7.2 billion won.

 

With the steep fall in sales of Nexavar and a significant increase in sales of Lenvima, the position of the two drugs has changed.

 

This is a first in 13 years since the drug started being used as a liver treatment and 3 years after the release of Lenvima.

 

Nexavar took a hard blow in February this year with its insurance ceiling being reduced by 30%.

 

The government cut Nexavar’s drug price 30% ex officio from 18,560 won to 12,992 won.

 

This was because Hanmi Pharm’s released Nexavar’s generic after overcoming Nexavar’s patent.