A Swiss clinical assessment has confirmed that ginkgo biloba extract improves cognitive function, with positive findings also reported for peripheral arterial occlusive disease and dizziness.
A health technology assessment (HTA) report commissioned by Switzerland's Federal Office of Public Health (FOPH) was recently made public. The report was prepared by Cencora, a local healthcare consulting group.
To establish the clinical and economic evidence for ginkgo biloba extract, the report analyzed results from more than 40 randomized controlled trials covering major indications including cognitive decline, peripheral arterial occlusive disease and dizziness, presenting efficacy and safety findings for each indication.
The report found clinically meaningful improvement in cognitive decline and also identified positive outcomes for peripheral arterial occlusive disease and dizziness.
The report is part of the reimbursement appropriateness assessment process and does not recommend delisting or restricting coverage. The FOPH is expected to make a final determination on reimbursement appropriateness after reviewing the HTA findings alongside stakeholder feedback.
South Korea is also conducting a reimbursement revaluation of ginkgo biloba preparations. The Ministry of Health and Welfare selected three active ingredients for revaluation in April: ginkgo leaf extract, calcium dobesilate hydrate and silymarin (milk thistle extract).
Overseas HTA reports serve as reference material in domestic revaluations, and the Swiss report is expected to be consulted during the review process. Health authorities will weigh overseas HTA findings alongside domestic clinical practice conditions, treatment guidelines and the availability of alternatives.
Ginkgo biloba extract, widely known as a circulatory aid, is prescribed in South Korea for dizziness, tinnitus and intermittent claudication — a condition in which leg pain occurs only during walking. More recently, as its benefits for cognitive decline have become recognized, it has also been prescribed for mild cognitive impairment and dementia.
The report assessed ginkgo biloba extract as having a clinically significant effect on cognitive decline. It concluded that administering 240 mg of the extract to patients with dementia-related cognitive decline improved cognitive function, neuropsychiatric symptoms, health-related quality of life and functional status compared with placebo.
On intermittent claudication — an indication currently covered under South Korea's national health insurance — the report drew on an analysis of peripheral arterial occlusive disease. The condition results from severe narrowing or blockage of the leg arteries, which restricts blood flow to the lower limbs. The hallmark symptom is intermittent claudication: the legs are pain-free at rest, but calf pain develops during walking and subsides when the patient stops.
A meta-analysis of randomized placebo-controlled trials found that patients receiving ginkgo biloba extract showed statistically significant improvements in both pain-free walking distance and maximum walking distance compared with placebo. After 24 weeks at doses of 120 mg and 160 mg, pain-free walking distance increased significantly versus placebo in both groups, with both results exceeding the minimum clinically important difference (MCID) of 20 meters cited in the literature. The 120 mg dose over 24 weeks was also associated with a statistically significant reduction in pain compared with placebo.
For dizziness, the report included results from two randomized active-controlled trials comparing ginkgo biloba extract with betahistine, an established dizziness treatment. The report found that improvement in dizziness-related symptoms after 12 weeks was comparable between the two groups. In a study comparing 240 mg of the extract with 32 mg of betahistine, the ginkgo biloba group showed a significantly lower risk of adverse events.
Reimbursement revaluations of prescription drugs are conducted periodically. Last year's review reclassified choline alfoscerate as a selective reimbursement drug, raising the patient cost burden. As prescriptions for that drug have declined, ginkgo biloba preparations — whose beta-amyloid-reducing effects have been confirmed — are rapidly displacing choline in the market.
According to Ubist, choline prescriptions in the first half of this year totaled about 208.6 billion won ($150 million), down 29.1 percent from the same period last year. Ginkgo biloba prescriptions came to about 53.7 billion won, up 32.4 percent year on year.
SK Chemicals and Yuyu Pharma were early entrants in the ginkgo biloba preparation market. Yuhan, Hanmi Pharm and IL Dong Pharmaceutical have since launched products with the same active ingredient.
Industry observers say there is no clear alternative to choline, which has long been prescribed for patients with mild cognitive impairment, and that ginkgo biloba preparations could play a central role in managing and improving dementia symptoms.
freiheit@heraldcorp.com
