Abstract
This study aims to analyze the trends of post-listing price changes for new drugs listed from 2007, when the health technology assessment (HTA) was introduced in South Korea, until 2017. We analyzed 135 products that have undergone price cuts. These products were analyzed by their respective review pathways, namely, pharmaco-economic study (PE), weighted average price (WAP), and the without a cost-effectiveness (CE) pathway. Prices were discounted faster in PE than in WAP (p = 0.002 in a comparison between PE and WAP). In addition, the median discount rate of the first price cut was 5.0% (range: 0.1–20.0) for PE, 3.0% (range: <0.1–30.0) for WAP, and 5.0% (range: 0.6–10.9) without a CE pathway. The median cumulative discount rate of PE and WAP showed that the PE pathway products’ discount rates were higher: 10.4% for PE and 6.0% for WAP (p = 0.025 for comparison between PE and WAP). It is necessary to discuss the practical effects of the price-cutting system from a myriad of perspectives, including insurance finance, the value of new drugs, and the accessibility of new drugs to patients.
Highlights
With improvements in medical technology and biotechnology, innovative new drugs, such as cell therapy products and immunotherapeutic products, including monoclonal antibody drugs, are being developed continuously
Pharmaceutical companies have to go through many hurdles to recoup research and development (R&D) expenses spent on developing new drugs and invest in R&D of other new drugs
The results of the categorization of 198 new drugs listed during the listing period are as follows: (27.3%) had gone through the pharmaco-economic study (PE) pathway, 21 (10.5%) without CE, and 123 (62.1%) through the weighted average price (WAP)
Summary
With improvements in medical technology and biotechnology, innovative new drugs, such as cell therapy products and immunotherapeutic products, including monoclonal antibody drugs, are being developed continuously. Pharmaceutical companies have to go through many hurdles to recoup research and development (R&D) expenses spent on developing new drugs and invest in R&D of other new drugs In this situation, patients can benefit from taking advantage of innovative new drugs to treat their disease, which makes for a virtuous cycle [3]. The health technology assessment (HTA) body, which ought to efficiently distribute limited resources regarding the reimbursement and pricing of new drugs, needs to consider patients’ access, and the budget impact of new drugs. In this context, it is natural for stakeholders’ stance related to new drugs to be contradictory. Anti-cancer drugs, and cell/genetic therapy products, in particular, are required by very few patients; these have
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