GE Healthcare Japan Expands Insurance Coverage for Alzheimer’s PET Imaging with Vizamyl

GE Healthcare Japan Expands Alzheimer’s PET Imaging Coverage

GE Healthcare Japan, headquartered in Hino City, Tokyo, is pleased to announce significant advancements in Alzheimer’s diagnostics with the expansion of insurance coverage for its amyloid PET imaging agent, Vizamyl™, synthesized using the FASTlab and FASTlab 2 systems. Effective from June 1, 2025, this expansion aims to facilitate more accessible and efficient diagnostic procedures for individuals suspecting Alzheimer's disease.

Vizamyl and Its Role in Alzheimer’s Diagnosis

Vizamyl is a pioneering radiopharmaceutical agent designed for use in PET scans to visualize amyloid beta plaques in the brain, which are indicative of Alzheimer’s disease. This non-invasive imaging technique allows for the evaluation of amyloid beta deposits and holds significant promise for early diagnosis of cognitive impairment and dementia due to Alzheimer’s. By enabling timely treatment decisions, Vizamyl plays a critical role in managing patients with mild cognitive impairment and suspected dementia.

In May 2015, GE Healthcare Japan received regulatory approval for the Vizamyl synthesis capabilities of the FASTlab platform, allowing for efficient visualization of amyloid beta plaques in patients with suspected Alzheimer’s disease. Further approvals were granted in October 2023 to include patients with mild cognitive impairment related to Alzheimer's.

New Therapy Approval and Diagnosis Requirement

In recent developments, the domestic market has begun offering a treatment drug named lecanemab, approved for the treatment of mild cognitive impairment and mild dementia associated with Alzheimer’s disease. One requirement for prescribing lecanemab includes confirming findings indicative of amyloid beta pathology using an approved diagnostic method. Consequently, starting October 2024, the use of Vizamyl in PET imaging will be eligible for insurance reimbursement to determine the need for therapy.

In addition to lecanemab, the approval of donanemab as a treatment in 2024 requires amyloid PET imaging to ascertain treatment efficacy and make decisions regarding treatment continuation or discontinuation.

Benefit of On-Site Synthesis and Expanded Accessibility

The expansion of insurance coverage for PET imaging using Vizamyl synthesized via FASTlab and FASTlab 2 systems enables a broader range of medical facilities to perform these vital tests. Currently, around 150 of the nearly 400 domestic medical facilities with PET/CT/PET/MRI systems have cyclotrons capable of on-site synthesis of radiopharmaceuticals, increasing accessibility and efficiency in Alzheimer's diagnostics.

Healthcare facilities utilizing the FASTlab technology can synthesize multiple PET agents, enhancing the flexibility and cost-effectiveness of diagnostic workflows. In Japan, efficient on-site synthesis is crucial, especially in regions where geographic challenges hinder the supply of radiopharmaceuticals from manufacturers. By ensuring timely access to these essential imaging agents, GE Healthcare Japan aids in addressing disparities in healthcare accessibility.

Addressing Japan's Aging Population

With Japan's aging society, the prevalence of dementia is anticipated to surpass 7 million by 2025, indicating that 1 in 5 elderly individuals may be affected. As the population ages, appropriate usage of treatment drugs like lecanemab and the incorporation of advanced diagnostic procedures, including amyloid PET scans, will be critical in managing Alzheimer's disease effectively.

The recent insurance coverage expansion marks a milestone in supporting better healthcare outcomes for patients with Alzheimer’s disease. As GE Healthcare Japan continues to innovate, the impact of assessments through Vizamyl-based PET imaging is set to deliver significant improvements in early diagnosis and patient care.

About GE Healthcare Japan
Founded in 1982, GE Healthcare Japan serves as a core part of GE Healthcare, focusing on precision care that encompasses prevention, diagnosis, treatment, and ongoing management. With approximately 1,700 employees and multiple operational sites, GE Healthcare Japan is dedicated to addressing the unique healthcare challenges present in the country.

For further details, visit GE Healthcare Japan's website.