'Liver Miracle Cure?' Silymarin Excluded from Health Insurance Coverage Due to 'Insufficient Clinical Evidence of Usefulness'

[Asia Economy Reporter Chunhee Lee] The silymarin ingredient, known for its effectiveness in liver diseases, has been finally excluded from the health insurance coverage due to insufficient clinical utility evidence.

On the 25th, the Ministry of Health and Welfare held the 25th Health Insurance Policy Deliberation Committee meeting of 2021 and announced that, based on the results of the 2021 re-evaluation of benefit appropriateness, silymarin and bilberry dry extract ingredients were excluded from health insurance coverage due to insufficient clinical utility evidence.

Silymarin is known to be effective for ▲hepatitis ▲liver cirrhosis ▲toxic liver diseases, and bilberry dry extract is known to be effective for ▲diabetic retinopathy ▲night blindness, but both ingredients were judged to lack clinical utility. Therefore, drugs containing these ingredients will no longer be eligible for health insurance benefits.

The Ministry of Health and Welfare has been deciding whether to maintain or exclude health insurance coverage for evaluated ingredients by establishing selection criteria and evaluation standards for re-evaluation of benefit appropriateness to improve drug expenditure efficiency. Last year, choline alfoscerate, which was evaluated as a brain function enhancer, was removed from the benefit list through evaluation.

Additionally, the avocado-soya ingredient, known to alleviate symptoms of adult knee osteoarthritis, has unclear clinical utility but was conditionally maintained for coverage due to cost-effectiveness compared to alternative drugs, with the condition that clinical utility must be proven in textbooks or clinical practice guidelines within one year. For Vitis vinifera (grape seed extract), coverage was maintained for blood circulation, retinal, and choroidal circulation, but excluded for its adjunctive effect in lymphedema caused by breast cancer treatment due to insufficient clinical utility evidence.

Meanwhile, the Health Insurance Policy Deliberation Committee decided to newly apply health insurance coverage from next month for Jevynix 200 and 800 mg by Hwanin Pharmaceutical, an epilepsy treatment, and Wakix film-coated tablets 5 and 20 mg by Mitsubishi Tanabe Pharma Korea Co., Ltd., a narcolepsy treatment. These results were determined through the Drug Benefit Evaluation Committee of the Health Insurance Review and Assessment Service evaluating clinical utility, cost-effectiveness, opinions from related academic societies, and listing status in other countries, followed by price negotiations in the health insurance space, resulting in the setting of upper limits (or expected claim amounts).

Accordingly, the annual medication cost for Jevynix, currently about 300,000 KRW, is expected to decrease to about 90,000 KRW, reducing the patient burden, and for Wakix film-coated tablets, the patient burden is expected to decrease from 310,000 KRW annually to about 30,000 KRW when applying a 10% co-payment under the special calculation disease category.

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