Long-acting RSV Antibody: NHI Review Awaits Manufacturer Submission
Taiwan's National Health Insurance (NHI) Administration is awaiting a formal application from the manufacturer to include long-acting RSV monoclonal antibodies in its coverage. While current NHI coverage supports premature infants with short-term antibodies, the new drug offers up to six months of protection. Experts emphasize the high risk for infants under one year old and recommend maternal vaccination or infant antibody administration.
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Central News Agency, Taipei, May 24: The National Health Insurance (NHI) currently covers RSV monoclonal antibodies for premature infants, providing about one month of protection. Newer long-acting products can offer up to six months of protection. Whether these will be included in NHI coverage depends on the manufacturer's submission. Physicians warn that infants under one year old are a high-risk group and suggest evaluating maternal vaccination or administering monoclonal antibodies to infants.
RSV is prevalent in Taiwan year-round, and about one-third of infected infants may require hospitalization. High-risk groups for severe RSV include infants under one year old, premature infants, and those with congenital heart disease or respiratory abnormalities. A long-acting monoclonal antibody for infection prevention was officially launched in 2024 and approved in the U.S.; it provides up to six months of protection when administered at birth.
Previously, the NHI only covered traditional RSV monoclonal antibodies for premature infants born before 33 weeks, providing about one month of protection per dose, with six doses covered. Since June 1 last year, this was expanded to premature infants born before 36 weeks (35 weeks and 6 days), covering three doses. This benefits approximately 8,600 premature infants annually, with an annual NHI expenditure of about NT$400-500 million, saving parents up to NT$60,000.
The NHI Administration stated tonight that the long-acting RSV monoclonal antibody underwent parallel review in June 2024 and received its drug license in September 2024. However, the manufacturer has not yet submitted a formal application for reimbursement. Once submitted, it will be processed according to administrative procedures.
Dr. Hsu Chung-ting, Director of General Pediatrics at Taichung Veterans General Hospital, warns that RSV is a common pathogen in infants. While it may appear to be "just a cold," it poses significant health risks to infants under one year old. Due to narrow airways, excessive secretions, and poor ability to clear phlegm, their condition can deteriorate rapidly, leading to severe bronchitis or asthma-like symptoms requiring hospitalization.
Dr. Hsu further pointed out that studies show newborns infected with RSV have three times the risk of developing asthma within five years compared to the general population. RSV prevention focuses on environmental management, especially in kindergartens or daycare centers. Older siblings can easily bring the virus home, increasing the risk for newborns. In addition to maternal vaccination during pregnancy, administering monoclonal antibodies to infants provides an immediate protective shield.
Dr. Hsu explained that maternal vaccination during pregnancy trains the immune system, taking about two weeks to transfer antibodies to the baby via the placenta, providing initial protection. However, this protection wanes over time. It is generally recommended to evaluate an additional dose of long-acting monoclonal antibody starting at three months of age to extend protection.
Administering RSV monoclonal antibodies to babies is another preventive method. Dr. Hsu stated that monoclonal antibodies act like sending troops directly into the baby's body to establish an immediate defense line, with a 90% protection rate against severe illness and over 70% against infection. It is suitable for babies in daycare centers or crowded environments, providing immediate protection and the convenience of being administered alongside other routine vaccines.
RSV is prevalent in Taiwan year-round, and about one-third of infected infants may require hospitalization. High-risk groups for severe RSV include infants under one year old, premature infants, and those with congenital heart disease or respiratory abnormalities. A long-acting monoclonal antibody for infection prevention was officially launched in 2024 and approved in the U.S.; it provides up to six months of protection when administered at birth.
Previously, the NHI only covered traditional RSV monoclonal antibodies for premature infants born before 33 weeks, providing about one month of protection per dose, with six doses covered. Since June 1 last year, this was expanded to premature infants born before 36 weeks (35 weeks and 6 days), covering three doses. This benefits approximately 8,600 premature infants annually, with an annual NHI expenditure of about NT$400-500 million, saving parents up to NT$60,000.
The NHI Administration stated tonight that the long-acting RSV monoclonal antibody underwent parallel review in June 2024 and received its drug license in September 2024. However, the manufacturer has not yet submitted a formal application for reimbursement. Once submitted, it will be processed according to administrative procedures.
Dr. Hsu Chung-ting, Director of General Pediatrics at Taichung Veterans General Hospital, warns that RSV is a common pathogen in infants. While it may appear to be "just a cold," it poses significant health risks to infants under one year old. Due to narrow airways, excessive secretions, and poor ability to clear phlegm, their condition can deteriorate rapidly, leading to severe bronchitis or asthma-like symptoms requiring hospitalization.
Dr. Hsu further pointed out that studies show newborns infected with RSV have three times the risk of developing asthma within five years compared to the general population. RSV prevention focuses on environmental management, especially in kindergartens or daycare centers. Older siblings can easily bring the virus home, increasing the risk for newborns. In addition to maternal vaccination during pregnancy, administering monoclonal antibodies to infants provides an immediate protective shield.
Dr. Hsu explained that maternal vaccination during pregnancy trains the immune system, taking about two weeks to transfer antibodies to the baby via the placenta, providing initial protection. However, this protection wanes over time. It is generally recommended to evaluate an additional dose of long-acting monoclonal antibody starting at three months of age to extend protection.
Administering RSV monoclonal antibodies to babies is another preventive method. Dr. Hsu stated that monoclonal antibodies act like sending troops directly into the baby's body to establish an immediate defense line, with a 90% protection rate against severe illness and over 70% against infection. It is suitable for babies in daycare centers or crowded environments, providing immediate protection and the convenience of being administered alongside other routine vaccines.
FAQ
Is RSV prophylaxis covered by Taiwan's NHI?
Currently, it is only covered for specific premature infants.