Improving access to Lenvima and its later-line treatment

Cancer Deliberation Committee may talk about coverage on Lenvima in later-line settings

Lenvima shows superior ORR and PFS against Nexavar, but lacks second-line treatment

#1 The Korean pharmaceutical industry is keeping a close eye on the Cancer Deliberation Committee’s June meeting to discuss the coverage on later-line treatment following Lenvima treating liver cancer.

 

The pharmaceutical industry sources reported the Cancer Deliberation Committee could talk about extending the access of patient with hepatocelluar carcinoma on Eisai’s Lenvima (lenvatinib) to second-line treatment.

 

The medical experts have been in a heated dispute over the access of second-line treatment against liver cancer.

 

When a patient is to choose Lenvima over Bayer’s Nexavar (sorafenib) for the NHI-covered first-line treatment, there is no later-line treatment with the NHI coverage.

 

Before the launch of Lenvima, Nexavar was the only option for treating patients with liver cancer.

 

Over a decade, Nexavar has been the only hope as many pharmaceutical companies have failed developing another treatment option.

 

And then along came Lenvima that conducted head-to-head clinical study against Nexavar and demonstrated improved overall response rate (ORR) and progression-free survival (PFS).

 

But its overall survival (OS) was not a significant improvement against sorafenib.

 

Regardless of the OS result, Lenvima’s clinical evidences were meaningful.

 

A novel treatment option for liver cancer is rare.

 

For many years, sunitinib, brivanib, linifanib and erlotinib have challenged against sorafenib’s position to treat patients with liver cancer who cannot easily expect five-year survival.

 

And eventually, they all have failed.

 

, But Lenvima still lacks a second-line treatment option.

 

On the contrary, Bayer has released liver cancer treatment Stivarga (regorafenib) and even received NHI reimbursement in Korea.

 

Stivarga’s indication and reimbursement standard focus on ‘patients who have failed treatment through Nexavar.’ Basically, Lenvima threatened Nexavar’s position with superior ORR and PFS outcomes, but Nexavar has provided a later-line option in case it fails.

 

Accordingly, the recently updated 2018 Korean Liver Cancer Association-National Cancer Center Korea Practice Guidelines for the Management of Hepatocelluar Carcinoa lowered the recommendation class of Lenvima than Nexavar.

 

It caused a fierce conflict within the academic society, but the conclusion has been made.

 

Although the U.S.

 

and European medical experts recommend two drugs at a same class, the Korean healthcare professions have decided otherwise.

 

Surely, there were many Korean specialists who argued the two treatments should be at a same level, and other academic society with reliable prescription experience has submitted a formal statement.

 

Professor Lim Ho Yeong of Hematology and Oncology Department at Samsung Medical Center commented, “As the liver cancer does not have so optimistic prognosis, access on covered later-line treatments are integral and urgent.

 

A treatment option with promising effect having a limitation, only because it lacks later-line treatment option, is regrettable.” Moreover, the professor added, “A retrospective analysis has recently confirmed Lenvima effectively prolonging OR in patients who have continued with later-line treatment after frontline Lenvima treatment.

 

As a result, academic societies are also raising their voice again to enhance patients’ access to the treatment.”