Supreme Court Dismisses Lawsuit Against Reduction of Coverage for Choline Alfoscerate
The legal controversy over the reduction of health insurance coverage for Choline Alfoscerate, a brain function enhancer, has been concluded.
The Supreme Court dismissed the lawsuit filed by pharmaceutical companies seeking to cancel the coverage reduction, ruling that the government's decision was appropriate.
As a result, patients without a dementia diagnosis must now bear 80% of the cost of Choline Alfoscerate.
Supreme Court Ruling: Dismissal of Lawsuit Against Reduction of Coverage for Choline Alfoscerate
According to news from the pharmaceutical industry on the 13th, the Supreme Court's Special Division 1 dismissed the claim of 25 individuals, including Jongkundang, requesting the cancellation of the announcement regarding the selective insurance coverage for health insurance drugs. As a result, the government's decision on the coverage reduction made in the first and second trials remained final.
The Ministry of Health and Welfare announced a partial revision of the "Details on the Standards and Methods for the Application of Nursing Benefits" in August 2020. According to this revision, the out-of-pocket ratio for patients without a dementia diagnosis using Choline Alfoscerate has increased from the previous 30% to 80%.
Pharmaceutical companies opposed this measure, claiming it was unjust, and filed an administrative lawsuit, but the Supreme Court's final ruling has confirmed the coverage reduction. This outcome is expected to have a significant impact on the pharmaceutical industry.
Coverage Criteria and Changes for Choline Alfoscerate
According to the announcement from the Ministry of Health and Welfare, new coverage criteria for Choline Alfoscerate have been established.
Coverage applies only to patients diagnosed with dementia who experience secondary symptoms or degeneration due to cerebrovascular issues. In contrast, patients without a dementia diagnosis will have an out-of-pocket ratio of 80% as per the "Criteria for Designation and Implementation of Selective Coverage."
This represents a significant change compared to previous coverage criteria and imposes a greater financial burden on patients prescribed medications for general cognitive decline rather than dementia treatment. This change is expected to create a new situation for patients and influence the approach to treatment.
Pharmaceutical Companies' Opposition and Legal Progress
Pharmaceutical companies have argued that the coverage reduction is an unjust restriction on clinically proven drugs and have taken legal action. This lawsuit was conducted in two groups according to their legal representatives, with one lawsuit involving Jongkundang and 39 other pharmaceutical companies and 8 individuals, and another including Daewoong Bio and 39 other pharmaceutical companies and 1 individual.
The Jongkundang group lost in the first trial held in July 2022 and faced the same outcome in the appeal trial in May 2023. They subsequently filed an appeal with the Supreme Court last June but received a dismissal ruling nine months later, resulting in final defeat.
In contrast, the Daewoong Bio group's lawsuit is still ongoing at the second trial stage. After losing in the first trial in November 2022, they submitted an appeal, and after five hearings, the arguments were concluded last January, but a ruling has yet to be issued. This situation is significantly impacting the pharmaceutical industry.
Alternative Treatments for Mild Cognitive Impairment Patients
Due to the reduction in coverage for Choline Alfoscerate and the clinical reevaluation, interest in alternative drugs has increased. Currently, there are several major medications suitable for treating mild cognitive impairment (MCI) in the country. These medications hold the potential to offer new hope to patients.
1. Nicergoline - Samion Tablet
Research on Subjective Cognitive Impairment (SCI) and Mild Cognitive Impairment (MCI) is still insufficient. However, cognitive improvement effects have been observed in patients with small vessel diseases. Therapy costs are subsidized for sequelae of cerebral infarction, and potential side effects to be cautious of include bradycardia, orthostatic hypotension, and decreased kidney function. These factors should be considered.
2. Ginkgo Biloba Extract
There is clinical evidence regarding Mild Cognitive Impairment and Vascular Cognitive Impairment (VCI). Its combined use with Donepezil has shown effects in slowing cognitive decline. This is an option that can be administered alone or in combination.
According to key research findings, it has been reported that this treatment can reduce the risk of dementia. Improvement of symptoms of Mild Cognitive Impairment has been proven in more than four studies in randomized controlled trials (RCT).
3. Combination Therapy with Donepezil
For patients with mixed dementia, the combined use of Donepezil and Choline Alfoscerate can enhance cognitive function. This combination therapy is more effective than Donepezil monotherapy in improving behavioral and personality changes. However, it has not been confirmed to be effective for general memory decline.
Future Prospects for Choline Alfoscerate
A clinical re-evaluation of Choline Alfoscerate is underway, with results expected to be disclosed later this year or early next year. In Europe, the approval for this medication was canceled years ago due to a lack of evidence, and similar outcomes may occur in South Korea as well. In this scenario, physicians must exercise caution regarding the use of Choline Alfoscerate and closely review the efficacy and safety of alternative medications.
With the recent Supreme Court ruling confirming the coverage reduction, it is anticipated that the financial burden for patients will increase. As a result, alternative medications such as Ginkgo Biloba are likely to be prescribed more actively for patients with Mild Cognitive Impairment. Future additional clinical results and changes in government policy are expected to significantly alter the trajectory of the cognitive enhancement market.
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