For the first time, the NHI has agreed to reimburse approved drugs for off-label uses to help save premature infants. Dr Shih Chung-Liang, Director-General of the NHIA, stated that the approved off-label uses are intended to treat retinopathy and ductus arteriosus insufficiency, which are common in premature infants. This new reimbursement regulation could take effect as early as February 2025.
According to statistics from the Health Promotion Administration, of the 135,614 newborns in 2023, 10.87% were born prematurely. The average treatment cost for a premature baby is NT$110,000 for the first six months. The NHIA is working on providing NHI-reimbursed treatments to help ease the financial burden on families.
Dr Shih highlighted that drug availability for young children, including newborns, is limited due to the small market size and specific product requirements. To address this, the NHIA has launched a platform to coordinate the procurement of and the access to pediatric drugs. Licensed drugs are given priority for NHI listing, while drugs not yet licensed in Taiwan may be imported through special projects.
Despite these efforts, a treatment gap remains. Therefore, the NHIA has made an unprecedented decision to approve reimbursement for off-label uses.
Dr Shih noted that, with advancements in medicine and research, the clinical guidelines for some drugs have expanded their indications. However, some manufacturers have not filed official applications to extend their uses. As a result, these off-label uses are not eligible for NHI reimbursement.
Therefore, the NHIA has adopted a flexible approach to address the issue of access to three key drugs for treating newborns. They are: vascular inhibitory drugs for retinal disease, Acetamol for treating patent ductus arteriosus (PDA), and respiratory stimulants. The NHIA has already submitted the proposal to the NHI Drug Dispensing Items and Fee Schedule Joint Establishment Meeting. Once approved, the NHI will begin reimbursing these treatments to help reduce the financial burden on families with premature babies.
Dr Wang Der-Yuan, Deputy Director-General of the TFDA, expressed that the TFDA will make every effort to support the access to drugs for treating children, for example, by reducing the application fees for expanding the indications of approved drugs.
【2024-11-06 / United Daily】
