3 Modes of National Health Insurance for Cancer NGS Testing to be Maintained and Launched in the Second Quarter of 2024

Dec. 21, 2023, National Health Insurance Administration (NHIA) held its third meeting to discuss the reimbursement plan for Next-Generation Sequencing (NGS). Director-General Shi Chongliang stated that 3 models are being considered, with an initial estimate of covering genetic testing for fewer than 30 gene loci under the health insurance scheme. The exact amount and the number of beneficiaries are yet to be estimated, but the plan is on track to be implemented in the second quarter of 2024.

The Trend of Precision Medicine in Cancer Treatment

Precision medicine or personalized medicine is becoming a trend in cancer treatment, with emerging targeted therapies and immunotherapies often requiring biomarker testing to identify genetic mutations for treatment targets. The Ministry of Health and Welfare’s Central Health Insurance Agency convened a meeting today to discuss the reimbursement standards for Next-Generation Sequencing (NGS).

Key Discussions and Decisions from NHIA’s Meeting

After the meeting, Shi spoke to the media, stating that the main discussion focused on the reimbursement models, requirements for executing medical institutions and laboratories, and qualifications for executing physicians. A final decision has not yet been made, and another meeting is expected in January 2024 to discuss aspects such as the timing of testing. The costs and beneficiary numbers will be calculated after the next meeting, with the plan on schedule to be launched in the second quarter of next year.

Classification of Genetic Testing Loci for Therapeutic Drugs

Shi mentioned that the meeting decided on the genetic testing loci for therapeutic drugs, maintaining 3 categories. The first category includes about 15 items of gene loci for targeted drugs already covered by health insurance. The second category comprises about 9 gene loci for targeted drugs that have obtained a drug license from the Ministry of Health and Welfare’s Food and Drug Administration but are not yet covered by health insurance. The third category includes about 41 gene loci for targeted drugs under clinical trials.

The First Phase of NGS Health Insurance Reimbursement Plan

Shi pointed out that the first phase of the NGS health insurance reimbursement plan would mainly cover the first and second categories. The third category is not considered for reimbursement yet, but patients can choose to undergo expanded testing at their own expense. Although 11 cancer types were initially suggested by various medical associations during the second meeting, the types of cancer eligible for reimbursement need to be reorganized after the third meeting.

Proposed Health Insurance Reimbursement Models for Cancer NGS Testing

Shi explained that 3 health insurance reimbursement models for cancer NGS testing are initially designed. The first model covers the basic gene loci for each cancer type, such as the long segments of the BRCA1 and BRCA2 genes, which will be reimbursed independently. The second model covers a small set of fewer than 50 basic gene loci for tumor cancer types. The third model covers the cost model for large sets of more than 50 gene loci.

Eligibility Criteria for Hospitals and Laboratories Conducting NGS Tests

Regarding the level of hospitals authorized to conduct the tests, Shi stated that considering the need to treat cancer patients primarily with targeted drugs, the consensus was to allow regional hospitals and above, molecular laboratories listed by the Food and Drug Administration, laboratories certified by the Taiwan Society of Pathology or approved by the American Society of Pathology, among other conditions. The signing and interpretation of reports by physicians must meet the requirements set by the Ministry of Health and Welfare’s Medical Affairs Bureau.

Future Plans and Considerations for NGS Testing Timing and Eligibility

Shi anticipates that the next meeting will discuss the timing of NGS testing, which must align with the recommendations of specialists in each field. It’s not feasible for all patients to directly undergo NGS testing. For example, in lung cancer, half of the patients can prioritize single-gene testing. If there’s a response to single-gene testing, treatment can be administered directly without performing NGS testing. A list of cancers eligible for single-gene testing will be compiled.

Reference:

1. https://eng.nhi.gov.tw/en/mp-2.html
2. https://udn.com/news/story/7266/7657323

Author

Oscar Wu