Korean Journal of Clinical Pharmacy

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
Disease
- 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 A7^b	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