The Hope Foundation for Cancer Care, the Taiwan's Alliance of Patients' Organizations, and the Foundation for Rare Disorders have jointly appealed for an "open, transparent, and traceable" new drug review process. The NHIA has acknowledged this appeal and highlighted its ongoing efforts in digital transformation, which will integrate digital management into the NHI listing assessment. This initiative aims to allow drug companies to trace the progress of their applications and to enhance review efficiency and transparency. Regarding empowering the public to inquire about the review progress, the NHIA clarified that, as it concerns drug companies’ rights, the NHIA will first gather comments from drug companies and industrial associations then convene a meeting to discuss this matter further.
Huang Yu-Wen of the NHIA emphasized the NHIA’s commitment to expediting the review process for the listing of new drugs and new indications. As of this year, the NHIA has already added 31 new drugs to the Benefit Scheme, comprising 8 cancer drugs, 10 orphan drugs and 13 other new drugs. Additionally, 24 extended reimbursements have been granted, including 11 cancer drugs, 1 orphan drug, and 12 other new drugs. Currently, there are six successful applications awaiting the official announcement.
Huang highlighted a remarkable 82% increase in the number of listed new drugs compared to the previous year, leading to substantial benefits for approximately 220,000 patients. Using new cancer drugs as an illustrative example, the recent listings have resulted in an annual cost savings of NT$3.51 million per patient.
In order to accelerate new drug listing, the NHIA has devised five improvement initiatives. Firstly, in order to increase patients’ access to new drugs, the NHIA has introduced a “temporary reimbursement system” for new drugs addressing unmet medical needs and qualified for TFDA’s accelerated approval pathway but not yet completing the Phase 3 clinical trials.
Secondly, the NHIA is set to inaugurate the “Health Policy and HTA Office” on January 1, 2024. The new Office will employ 110 staff members to take charge of HTA and to accelerate the review of new drug listing applications.
Thirdly, starting from next January, the NHIA will introduce the "parallel submission." This process allows drug companies to simultaneously submit applications for new drug authorization and NHI listing. The goal is to reduce the time between market authorization and the approval of NHI listing to just 6 months.
Fourthly, the NHIA has secured a fund of NT$7.093 billion for new drugs and new technologies under the NHI global budget. The funding will cover expenses related to new drugs, new special materials, new generation sequencing tests and the aforementioned temporary reimbursements. This represents an impressive growth rate of 116% compared to this year's fund of NT$3.819 billion.
Finally, the NHIA aims to secure additional funding outside the NHI global budget to establish an independent "new drug and cancer drug fund."
Huang Yu-Wen emphasized the NHIA's commitment to prioritizing patients' medical rights and maintaining an open ear to patient feedback. Acknowledging the constraints of limited NHI resources, the NHIA's strategy involves seeking more budget allocations from the government and engaging in negotiations with drug companies. The goal is to expedite the listing of new drugs and new treatments that demonstrate significant benefits for patients and are supported by robust clinical evidence.
【2023-12-04 / Unite Daily】
