Insurance benefit for Vemlidy expanded in Korea

brings generation shift in the HBV drug market

To be reimbursed for initial treatment of patients with liver cirrhosis and hepatocellular carcinoma

Q1 prescriptions ₩10.5 billion… 20% increase YoY

Would need to alleviate the prescription switching standards to break the stronghold of Viread·Baraclude

Pic of Vemlidy tab

The health authorities have extended the insurance benefit of Gilead Science’s chronic hepatitis B treatment ‘Vemlidy (tenofovir ala fenamide)’ to liver cirrhosis and hepatocellular carcinoma, accelerating the generation shift of HBV drugs in Korea.

 

According to the Ministry of Health and Welfare on the 3rd, Vemlidy’s reimbursement standards have been extended starting May 1st for the initial treatment of decompensated cirrhosis and hepatocellular carcinoma patients.

 

In the past, insurance benefit was only provided for patients who had been using Vemlidy for HBV and progressed to liver cirrhosis or hepatocellular carcinoma.

 

With the expansion of the reimbursement benefit, the phrase ‘reimbursement of oral tenofovir ala fenamide is not recognized for decompensated cirrhosis and hepatocellular carcinoma’ in the detailed recognition criteria for oral chronic HBV treatments has been deleted.

 

However, in patients with decompensated cirrhosis, reimbursement is only allowed when the patient has reduced kidney function or osteoporosis.

 

Quarterly prescriptions of Viread, Baraclude, Vemlidy (Unit: ₩100million, Source:UBIST)

Vemlidy is a next-generation HBV treatment that Gilead released as a follow-up treatment of ‘Viread (tenofovir).’ The company had improved safety and convenience in intake while maintaining the efficacy of its existing blockbuster HBV treatment Viread.

 

Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Viread.

 

Also, Vemlidy has improved toxicity issues such as the potential risk of nephrotoxicity that arose with the long-term use of Viread.

 

Gilead succeeded in expanding the indication of Vemlidy to liver cirrhosis and end-stage renal disease last year and then succeeded in expanding the scope of reimbursement for the drug this year.

 

By securing the scope of indications for which Viread and Baraclude were previously prescribed, the company was able to seek complete generation change.

 

Also, Vemlidy's share and position in the chronic hepatitis B treatment market continue to grow.

 

According to the market research institution UBIST, prescriptions of Vemlidy rapidly increased from ₩200 million in the first year of its release to ₩7.4 billion in the following year, then to ₩18.9 billion in 2019, and ₩29.7 billion in 2020.

 

Last year, prescriptions of Vemlidy rose 34% from the previous year to reach ₩39.8 billion.

 

Vemlidy is the only product that saw an increase in prescriptions among original hepatitis B drugs last year compared to the previous year.

 

Also, Vemlidy recorded ₩10.5 billion in Q1 this year, up 20% from the same period of the previous year.

 

However still, Viread and BMS’s Baraclude (entecavir) still tops the market as the No.1 and No.2 products, although the gap has narrowed significantly with Vemlidy’s sales continuing to grow while sales of Viread and Baraclude continue to fall.

 

Viread, which had an annual prescription of ₩184.3 billion in 2017, decreased to ₩170.3 billion in 2018 and ₩115.9 billion in 2019 due to the introduction of Vemlidy.

 

Last year, the drug recorded ₩951 billion.

 

Baraclude recorded prescriptions of around ₩77 billion in the same period.

 

One obstacle Vemlidy must overcome to achieve rapid generation change lies in the strict prescription switching standards for HBV drugs in Korea.

 

Unlike other chronic diseases, the standards for switching drugs in HBV are quite strict.

 

Patients should show tolerance or insufficient and non-response to treatment, justifiable decreased adherence, and objectively documented serious adverse reactions to switching their drugs.

 

Serious adverse reactions here include muscle enzyme elevation and neutropenia.

 

Switching drugs without justifiable cause will result in reimbursement cuts, and this is why Viread and Baraclude are maintaining their ₩170 billion prescriptions in the market.