HCV testing added to the National Health Screening Program

Pharmaceutical companies welcome the addition… improving the treatment rate remains a challenge

AbbVie and Gilead start second round of competition with their respective HCV treatments...need to consider marketing strategies

Its addition to the National Health Screening Program raises expectations on sales rebound of HCV treatments that are facing stagnant patient expansions

The government's decision to introduce the long-discussed hepatitis C antibody testing to the national screening program is expected to have a positive impact on its treatment market.

 

According to industry sources, the decision is encouraging as it enables the first step of identifying hepatitis C patients.

 

However, how to link diagnosis and treatment will be a challenge in the future, as the treatment rate has been dropping despite patient identification.

 

Recently, the Ministry of Health and Welfare held the 2nd National Health Screening Committee Meeting in 2024 and confirmed the introduction of new hepatitis C testing and the expansion of osteoporosis screening subjects in Korea’s general health screening program.

 

As a result of the decision, people aged 56 and older will be able to receive an antibody test for hepatitis C during national health screening from 2025.

 

According to the Korean Association for the Study of the Liver (KASL), hepatitis C is responsible for about 10% to 15% of liver cancer cases in Korea.

 

Between 54% and 86% of hepatitis C patients progress to chronic hepatitis, and 15% to 51% of which progress to cirrhosis.

 

The risk of liver cancer in cirrhosis is 1-5% per year, with the risk increasing with age.

 

However, hepatitis C can be cured by taking oral antiviral drugs for 8 to 16 weeks, so screening and treating infected people early is the best way to prevent the spread of the disease.

 

This is why the pharmaceutical industry’s hopes are rising on how the introduction of hepatitis C testing will lead to increased patient identification and treatment.

 

An industry official said, "There had been a large unmet need in hepatitis C, but due to a lack of policy and awareness, many patients were unaware of their infection and were diagnosed late, often after the disease had progressed to liver cancer.

 

The industry is pleased that a meaningful policy has been established." Will sales of AbbVie and Gilead’s treatments also rebound? Currently, the leading hepatitis C treatments are AbbVie’s Mavyret (glecaprevir/pibrentasvir) and Gilead Sciences' Epclusa (sofosbuvir/velpatasvir) and Vosevi (velpatasvir/sofosbuvir/voxilaprevir).

 

In terms of sales,  Mavyret sold KRW 57.3 billion in 2019, KRW 46.9 billion in 2020, KRW 46.6 billion in 2021, KRW 39.3 billion in 2022, and KRW 24.3 billion in 2023, showing a yearly decline.

 

Epclusa and Bosebi Vosevi to generate sales in earnest after being granted reimbursement in November 2022, generating KRW 16.1 billion and KRW 3.5 billion respectively last year.

 

In general, Mavyret’s sales have declined with Epclusa and Bosebi taking its place.

 

However, the overall market for hepatitis C drugs has been on a decline or drifting sideways.

 

Since 2020, the combined sales of the 3 products have been in the low to mid KRW 40 billion range.

 

This is not unrelated to the decline in the number of hepatitis C patients in Korea.

 

According to statistics from the Korea Disease Control and Prevention Agency’s Infectious Disease Portal, the number of hepatitis C patients decreased from ▲11,849 in 2020 to ▲11,115 in 2021, ▲8,308 in 2022, and ▲7,225 in 2023 Considering this situation, the introduction of hepatitis C antibody testing in the national health screening program is expected to lead to an increase in the use of hepatitis C treatment as well.

 

An official from the KASL said, "Our society has been pondering how to combat hepatitis C for a long time, and although it is late, we are glad that screening for hepatitis C became possible through the national health screening program.

 

The increase in screening will help us identify and treat patients at an earlier stage." However, there is also a view that additional efforts would need to be made to actively treat patients even after the national screening.

 

According to KASL’s Fact Sheet which was published in 2023, the cure rate for hepatitis C patients was only 58.1% in 2019.

 

This means that 4 out of 10 people diagnosed with hepatitis C do not actually receive treatment.

 

It's also unclear how well the national screening program will be able to identify patients, given that the target age for screening is 56.

 

For this reason, the KDCA is working on a plan to subsidize the cost of confirmatory tests for those who test positive for hepatitis C antibodies in the national health screening program so that they can be confirmed faster.

 

A doctor at A General Hospital said, "The problem in Korea has been the low screening rate itself.

 

Various studies have been conducted on how to treat the confirmed patients afterward.

 

I think the introduction of hepatitis C testing in the national health program will increase patient treatment as well as the use of treatment."