Healthcare Group, Lee & Ko, Seoul, 04532, Republic of Korea.
College of Pharmacy, Chung-Ang University, Seoul, 06974, Republic of Korea.
Ther Innov Regul Sci. 2023 Jul;57(4):759-768. doi: 10.1007/s43441-023-00531-3. Epub 2023 May 14.
Since introducing the positive listing system in 2007, the South Korean government has undergone multiple changes in its drug listing system. As there is a lack of studies that evaluate the system from an industry perspective, this paper examined South Korea's new drug listing system from the suppliers' perspective.
We surveyed members of the three main pharmaceutical industry associations online. The survey (a 5-point Likert scale) covered their satisfactory levels, demands, and updates on the current new drug listing system, especially pharmacoeconomic evaluation, pharmacoeconomic evaluation exemption, and risk-sharing agreement.
A total of 56 respondents participated in the survey. The self-reported satisfaction level for value recognition of new drugs was 1.6 (± 0.7) points (5 points = very satisfied). The most highly demanded reforms for PE, RSA, and PEE were incremental cost-effectiveness ratio threshold (92.9%), reimbursement scope expansion (91.1%), and eligible disease (83.9%). Lastly, they also claimed that the indication-based pricing system must be introduced (83.9%).
Pricing and reimbursement policies need to improve in such a way that would enable better access to new drugs while still facilitating their development. Given the nature of the current system, some innovative rare disease treatments and anticancer drugs remain unreimbursed, resulting in low satisfaction levels across the pharmaceutical industry. Hence, pathways to speed up the reimbursement assessment process and expand the range of reimbursable diseases are required. Pharmaceutical companies are also important stakeholders, like in the case of clinicians and patients, and their opinions should also be considered in the process of pricing and reimbursement policy reforms.
自 2007 年引入正面清单制度以来，韩国政府的药品上市制度经历了多次变革。由于缺乏从行业角度评估该制度的研究，本文从供应商的角度考察了韩国新药上市制度。
我们在线调查了三个主要制药行业协会的成员。该调查（5 分李克特量表）涵盖了他们对当前新药上市制度的满意度、需求以及更新情况，特别是药物经济学评价、药物经济学评价豁免和风险分担协议。
共有 56 名受访者参与了调查。新药价值认可的自我报告满意度为 1.6（±0.7）分（5 分表示非常满意）。PE、RSA 和 PEE 最需要改革的是增量成本效益比阈值（92.9%）、报销范围扩大（91.1%）和合格疾病（83.9%）。最后，他们还声称必须引入基于适应证的定价系统（83.9%）。
定价和报销政策需要改进，以便更好地获得新药，同时促进新药的开发。鉴于当前制度的性质，一些创新的罕见病治疗方法和抗癌药物仍未得到报销，导致制药行业整体满意度较低。因此，需要加快报销评估过程并扩大可报销疾病的范围。制药公司也是重要的利益相关者，就像临床医生和患者一样，在定价和报销政策改革过程中也应该考虑他们的意见。
