Table 1 Criteria for high-cost medicines in select three countries

1

Australia

Life-Saving Drug Program (LSDP)

1) The medicine should be clinically effective but not sufficiently cost effective to be listed on the Pharmaceutical Benefits Scheme (PBS)

2) the medicine is used to treat life-threatening and rare conditions (defined as 1 case per 50,000 people or less) and

3) if the pharmaceutical company (sponsor) applies for an LSDP listing

2

England

reformed Cancer Drugs Fund (CDF) & Highly Specialised Technology (HST)

1) Uncertainty in Incremental Cost-Effectiveness Ratio (ICER)

2) Increase health related quality of life (QoL)

3) Technology innovation

4) Medicine to extend one’s life

5) If indicated for diseases with short life expectancy and

6) Aspects that relate to non-health objectives of NHS such as equity

3

South Korea

Pharmaco-economic (PE) waiver

1) There is no alternative treatment

2) The new medicine treats a life-threatening or rare disease and/or cancer

3) Treats small patient group

4) Should have proven clinical efficacy and

5) The medicine should be listed in at least three of the seven A7 countries that Korea refers to for medicine prices (“A7” are seven countries: the United States, the United Kingdom, Italy, Germany, Japan, Switzerland, and France)