The current state of patient access to new drugs in South Korea under the positive list system: evaluation of the changes since the new review pathways

ABSTRACT

Objective: This study aims to provide an up-to-date analysis of the current state of patient access to new drugs in South Korea, focusing on the effect of new review pathways for reimbursement.

Methods: We analyzed patients’ access to new drugs, listing rate and lead time until listing from marketing authorization. New pathways were defined as ‘price negotiation waiver,’ ‘risk-sharing agreements,’ and ‘pharmacoeconomic evaluation exemption.’

Results: The listing rate for drugs increased after the introduction of the new pathways (93.7% vs. 77.9%, p < 0.001). Before the new pathways, the median lead time for listing was 21.0 months (95% CI: 16.9–25.0), while afterward it was shortened to 10.9 months (95% CI: 10.2–11.7) (p < 0.001).

Conclusion: Although it has strengthened national health insurance coverage by positively impacting the rate and lead time, the lead time for the oncology and orphan drugs is substantially longer as compared to other drugs. Expanding the eligibility criteria to include non-life-threatening but rare or intractable diseases, and resolving the system’s operational issues are still necessary.

KEYWORDS:

• Patient access
• listing rate
• lead time
• risk-sharing agreements
• price negotiation waiver
• pharmacoeconomic evaluation exemption

Author contribution statement

SJ Kim and HY Cho contributed equally to the study design, statistical analysis, and manuscript development under the guidance of JH Lee. JH Kim, SJ Kim, HY Cho, and KM Lee participated in data collection, data analysis, and manuscript review. JH Lee supervised the entirety of the study right from study designing, data collection and analysis, and manuscript editing to manuscript submission. All the authors have read and approved the final version of the manuscript.

Acknowledgments

We thank the following individuals in data collection: Hyunkyoo Yoo, Jaemin Cho, Kyungsik Kang, Jeehye Park, Seulki Lee, Jinhee Moon, and Jungdae Kim. We would like to thank Kyunghwa Lim, Sean Kim, and KRPIA (Korean Research-based Pharma Industry Association) for their support in this study.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.