Fig. 1.

In addition to conventional three hurdles for approval through development phase, two modern hurdles for patient access through diffusion phase are widely recognised these years: 4th hurdle for cost-effectiveness and 5th hurdle for affordability. These hurdles are appraised by cost-effectiveness analysis and budget impact analysis, respectively. Cost-effectiveness analysis concerns efficiency of resources use based on the valuations of cost and effectiveness at the same time comparing technical alternatives, while budget impact analysis concerns affordability of the government or the third party payer by demonstrating changes of cash flows as a result of making an intervention accessible for the population