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Table. 2.

Table. 2.

Comparison of alternative policies to improve drug access in Korea

Risk sharing agreement Waiver of cost-effective analysis Medically essential drugs Differential coverage systema
Time of introduction Dec-13 May-15 Jul-12 Dec-13
Cost-effective analysis required O X X O
Application condition
- Cancer or rare disease O* O O X
- Severe and incurable disease O* X X X
Clinical necessity
-No alternative treatment option O O* O O
-Severe enough to threaten life O O* O X
Difficulty in generating evidence X O O X
Clinically meaningful improvement O X X O
Other considerations Other considerations such as the severity of the disease, its social impact, and its impact on other health and medical care Registered in three or more countries among A7b Other cases where the committee deems it essential for the care of patients Social necessity

a Differently applied according to the degree to which each item in the application condition is applicable

b United States, United Kingdom, France, Germany, Italy, Switzerland, Japan

* Need to meet either one of two conditions

Need to meet both of the two conditions

Korean J Clin Pharm 2021;31:1-11 https://doi.org/10.24304/kjcp.2021.31.1.1
© 2021 Korean J Clin Pharm