Hepatology group pushes to revise hepatitis B reimbursement guidelines to prevent liver cancer

Calls are growing within Korea’s medical community to overhaul the country’s reimbursement criteria for chronic hepatitis B treatment, as experts warn that outdated standards are limiting access to early antiviral therapy and undermining efforts to reduce liver cancer incidence.

At the “2025 Hepatitis Academy” hosted by Gilead Sciences Korea on Tuesday, Professor Lim Young-suk of the Department of Gastroenterology at Asan Medical Center -- who is also president-elect of the Korean Association for the Study of the Liver (KASL) -- emphasized that current national guidelines and reimbursement policies do not adequately cover patients at risk of liver disease progression.

“The existing reimbursement rules, which rely heavily on alanine transaminase ALT levels as a treatment threshold, fail to capture many patients who urgently need therapy,” Professor Lim said during his keynote presentation. “We now have clear data showing that early treatment in patients with elevated viral load but normal liver enzyme levels can significantly reduce the risk of liver-related events.”

He presented interim findings from the multinational, randomized controlled ATTENTION study, which was conducted across 22 medical centers in Korea and Taiwan.

The trial evaluated the early use of tenofovir alafenamide (TAF) in chronic hepatitis B patients with normal or mildly elevated ALT levels.

Among 798 patients aged 40 to 88 with viral loads between 10,000 and 100 million IU/mL, the study found that those treated with TAF had a 79 percent lower incidence of major liver-related clinical events over four years compared to the placebo group.

Notably, no liver events occurred in the TAF group among patients with normal ALT levels, while eight events were reported in the placebo arm.

Professor Lim argued that these findings support removing ALT from the reimbursement criteria, instead recommending viral load and age as more accurate predictors for early intervention.

“ALT can give a false sense of safety,” he said. “It’s like a fire without smoke—just because you don’t see signs doesn’t mean there’s no damage.”

Korea’s current hepatitis B reimbursement policy requires both elevated viral load and abnormal ALT levels to qualify for treatment coverage.

This standard established more than two decades ago when antiviral options were limited and side effects were a major concern has not been updated in line with newer therapies like TAF and tenofovir disoproxil fumarate (TDF), which boast near-zero resistance rates and excellent safety profiles.

According to Lim, Korea’s hepatitis B diagnosis rate stands at 85 percent, yet only 21 percent of patients are receiving treatment.

“This gap is largely due to rigid reimbursement rules that exclude large portions of the patient population,” he said. “We estimate that lifting the ALT requirement could double the number of eligible patients from 300,000 to 600,000.”

While such a change could increase national health insurance expenditures for hepatitis B treatment from the current 250 billion won ($175 million) to 500 billion won annually, Professor Lim believes the policy shift would be cost-effective in the long term.

“The cost of treating one liver cancer patient for a year is about $30,000, whereas preventing the disease through early antiviral therapy costs only $2,500,” he said. “It’s a matter of public health efficiency.”

He added that revising the treatment guidelines is the first step toward influencing reimbursement policies governed by the Health Insurance Review and Assessment Service (HIRA).

“We are aiming to update the KASL guidelines by early next year and begin negotiations with HIRA in the first half of 2025,” he said.