'Anticancer Effect Is Excellent, 150 Million Won'... Enhertu, Which Only Korea Couldn't Access, Opens for Insurance Coverage

Only Korea Among Top 10 OECD Countries Has Non-Covered Services
mPFS 28.8 Months... 'Longer Survival Lowers Cost-Effectiveness'
BioHealth Innovation Committee "Will Recognize Innovativeness"

The anticancer drug 'Enhertu (generic name: trastuzumab deruxtecan),' which has excellent anticancer effects and allows patients to live longer, is expected to see a significant increase in total drug costs, causing difficulties in applying health insurance coverage. However, the application of health insurance coverage for Enhertu is becoming more visible. The discussion is expected to gain momentum as the government has decided to recognize exceptions for 'innovative new drugs' regarding the previously problematic cost-effectiveness evaluation.

AstraZeneca-Daiichi Sankyo's antibody-drug conjugate (ADC) Enhertu (generic name: trastuzumab deruxtecan)
[Photo by Daiichi Sankyo Korea]

Enhertu is a targeted therapy for metastatic breast cancer. According to the industry on the 27th, among the top 10 countries by Gross Domestic Product (GDP) within the Organisation for Economic Co-operation and Development (OECD) as of 2019, South Korea is the only country that does not apply health insurance coverage for Enhertu. Major countries such as the United States, the United Kingdom, Europe, Canada, and Japan all support coverage, and even when expanded to the entire OECD, more than 60% of countries have introduced coverage.

However, domestic coverage discussions have been sluggish. After approval by the Ministry of Food and Drug Safety, anticancer drugs must pass through the Cancer Disease Deliberation Committee and the Drug Benefit Evaluation Committee of the Health Insurance Review and Assessment Service, price negotiations with the National Health Insurance Service, and the Health Insurance Policy Deliberation Committee before coverage can be applied. Domestic approval was granted in September last year, and it passed the Cancer Disease Deliberation Committee in May, but the submission to the Drug Benefit Evaluation Committee, the next step, remains uncertain.

Developed by AstraZeneca (AZ) and Daiichi Sankyo (DS), Enhertu is a drug leading the 'antibody-drug conjugate (ADC)' trend. ADCs are drugs that connect antibodies binding to cancer antigens with cytotoxic drugs (payloads) that kill cancer cells via linkers. Known as 'cruise missiles' that precisely target cancer, they are attracting attention as next-generation anticancer technology. Enhertu is the first ADC approved in the breast cancer field, showing an innovative median progression-free survival (mPFS) of 28.8 months, during which patients live with the disease progression halted. Compared to existing treatments whose mPFS did not exceed 10 months, it demonstrated unprecedented survival improvement.

The problem is that this innovation has ironically become an obstacle. This is due to the 'incremental cost-effectiveness ratio (ICER)' system. New drugs must prove cost-effectiveness through economic evaluations to enter health insurance coverage. ICER is a key indicator in economic evaluations that measures how much more cost is required for a new drug to keep a patient healthier for one more year (quality-adjusted life years) compared to existing treatments. Currently, anticancer drugs must have an ICER of 50 million KRW or less to be eligible for coverage. However, Enhertu, with an annual treatment cost of about 150 million KRW, paradoxically has an excessively high ICER value due to its life-extending effect, causing it to be held back in economic evaluations. This is why breast cancer patients have petitioned the National Assembly with 50,000 signatures urging rapid expansion of Enhertu coverage under health insurance.

Prime Minister Han Duck-soo is delivering a greeting at the 1st Biohealth Innovation Committee held at the Government Seoul Office on the morning of the 22nd.
[Photo by Yonhap News]

However, the Biohealth Innovation Committee, launched directly under the Prime Minister on the 22nd with the agenda of improving 'killer regulations,' announced that it will provide 'appropriate compensation for the innovative value of new drugs,' which is expected to resolve such obstacles. The Innovation Committee decided to allow exceptional excess for drugs recognized for 'innovation,' such as extending survival periods. It appears to follow precedents in overseas countries like the UK, where exceptional criteria were applied to resolve issues caused by excessively high ICERs and approved Enhertu.

An industry official said, "The irony that the longer patients live, the harder it is to apply health insurance coverage is finally expected to be resolved," adding, "As innovative new drugs are being approved one after another overseas, the government needs to actively pursue institutional improvements to respond accordingly."

This content was produced with the assistance of AI translation services.