(By Chieh-Ling Chen from Central News Agency, Taipei, January 21) The National Health Insurance Administration plans to include coverage for next-generation sequencing (NGS) testing upon cancer diagnosis or when second-line or third-line therapies are unsuccessful. Under this plan, the NHI will cover one NGS test per cancer type for each insured individual. This measure is anticipated to be implemented as early as May, with an expected budget allocation of NT$1 billion.
Precision medicine has become an international trend, with testing playing a critical role in its implementation. Newly emerged targeted therapies and immunotherapies for cancer treatment often necessitate the identification of genetic mutations through biomarker testing to pinpoint treatment targets. NHIA Director General Chung-Liang Shih elaborated on the NHI coverage policy for NGS testing during a conference held on the morning of January 21st.
Director General Shih analyzed NHI data from 2022, revealing that a total of 830,000 patients sought medical attention for cancer that year. Of the 39.2 billion points spent on medications, the majority was allocated to targeted therapies, accounting for approximately 61.7% of all expenses. Currently, the NHI package covers 26 types of targeted therapy targeting 11 gene loci capable of treating 10 types of cancer. However, the NHI only covers SNP tests and PCR tests, with an annual budget of NT$600 million.
Considering the benefits and the limited funds, the NHI is planning to cover only NGS testing that takes place at the time of a cancer diagnosis or when second-line or third-line therapies fail, depending on the cancer type," said Director General Shih. "The finalized guidelines for the testing timing for each type of cancer shall be made with the consensus of relevant experts. The decision to take the test shall be made after exhaustive communication between doctors and patients. Each insured is eligible for one NHI-covered NGS test in their lifetime for each type of cancer, excluding cancer metastasis; the insured is eligible for another NHI-covered NGS test only when diagnosed with a different type of cancer.
Director General Shih explained the three payment methods planned for NGS test coverage: 1) Independent payment for relatively long genes such as BRCA1 and BRCA2; 2) Payment for a small set of fewer than 100 genes, based on the most basic gene loci of each type of cancer; and 3) Payment for a large set of more than 100 gene loci. The coverage will not entail a full reimbursement of the standard price, rather; it will consist of a fixed reimbursement amount to allow market flexibility; Patients can pay the difference in cost out of pocket to undergo the test that meets their needs.
Director General Shih mentioned that the NGS testing can assist with precision medication for various types of cancer. The technology is applicable for 19 types of cancer, including non-small cell lung cancer, triple-negative breast cancer, ovarian cancer/ fallopian tube cancer/ primary peritoneal carcinoma, intrahepatic cholangiocarcinoma, prostate cancer, melanoma, gastrointestinal stromal cancer, urothelial carcinoma, thyroid cancer/ medullary thyroid cancer, colorectal cancer, solid tumor with NTRK fusions, and pancreas cancer.
Finally, Director General Shih pointed out that the NGS test results hold significant research value. Therefore, compliant data collection methods are being studied and drafted to require hospitals to upload all test results to the National Health Insurance Research Database. Alternatively, patients will be provided with a consent form when receiving reimbursement, requesting their approval to have the test results saved in the National BioBank Consortium of Taiwan. These test results will be collected to enable regular reviews and determine the differences between the number of patients taking the test and those being medicated, to avoid significant gaps between the number of tests taken and the number of patients actually being treated.