As I understand the CDR process—and again I encourage members to ask this question of CDR representatives—if there is no active comparator in Canada for a drug, their process, which is a chart, defaults to a cost-effectiveness or budget impact analysis. This means that the drug will only be evaluated based on its budget or cost impact. That's just the way the process seems to work.
The challenge is that if you're first in class, you have no active comparator in this country against which to measure the drug. So what do you have left but the budget impact analysis?