The Department of Health's National Health Insurance Administration recently announced that next-generation gene sequencing (NGS) tests for a total of 19 cancer types will be included in national health insurance reimbursement starting from May 1st, with an estimated total reimbursement of about NT$300 million in the first year. Domestic genetic testing-related companies such as TSH Biopharm, KIM Forest, Genomics, Bionet, Sofiva, ACT Genomics, and LiBobio, one of subsidiaries of Lih Pao Group are optimistic about the synergy of health insurance reimbursement, expecting to drive the NGS testing market to exceed NT$1 billion.
The Department of Health stated that after NGS is included in health insurance reimbursement, a total of 14 types of solid tumors and five types of blood tumors can apply for fixed-rate health insurance reimbursement, with patients paying the difference. This provides each individual with a one-time reimbursement per cancer type for life. Units performing NGS testing must be limited to "regional-level or higher hospitals" or "cancer treatment quality-certified hospitals" and must be qualified to conduct Laboratory Developed Tests (LDTs) approved by the Department of Health. The National Health Insurance Administration estimates that about 20,000 cancer patients will benefit each year, injecting approximately NT$300 million in funds.
In addition to hospitals establishing their own LDTs laboratories, many biotech companies have also collaborated with hospitals in recent years, with biotech companies with LDTs laboratories and NGS equipment commissioned by hospitals to carry out business operations. Take Golden Million Biotech as an example; the company has long had a Department of Health-certified LDTs laboratory. Currently, it has cooperated with more than 30 hospitals and over 50 clinics nationwide, covering all cancer testing items opened by the Department of Health.
Si-Yuan Yang, General Manager of TSH Biopharm, stated that the company's NGS testing business is conducted in collaboration with six foreign companies and is undergoing Department of Health review for LDTs laboratory certification. Once approved, there is an opportunity to compete for NGS health insurance reimbursement scheduled for May. TSH Biopharm's NGS testing items include blood, tissue, and pleural fluid, with organ testing, the reimbursement item opened by the National Health Insurance Administration in the first year, accounting for only 15% of TSH Biopharm's NGS revenue last year. The company is confident that it has the opportunity to challenge 50% of the tissue testing market in Taiwan in the future, with an estimated market share of over 5% in health insurance.
Jun-Qi Jiang, General Manager of Genomics, explained that the company's NGS revenue accounts for about 30%. To comply with the NGS inclusion in health insurance payment from May 1st, Genomics has applied to the Department of Health for LDTs laboratory certification. The company has applied for NGS reimbursement items for large panels (more than 100 genes), which can conduct all cancer tests. Genomics is also in negotiations with three or four hospitals to strive for more NGS business opportunities in the future.
Other biotech companies that have established or are developing NGS businesses include Bionet, ACT Genomics, LiBobio, Taiwan Genomics Industry Alliance, and ALLBio, among others.
Resource (Mandarin):
