Criteria used by Health Canada in determination of priority review and by Human Drug Advisory Panel and Prescrire International in determining innovation status
| Health Canada—criteria for priority review12 | Human Drug Advisory Panel of Patented Medicine Prices Review Board—criteria for breakthrough and substantial improvement6 | Prescrire International—criteria for bravo, a real advance and offers an advantage8 |
|---|---|---|
| A serious, life-threatening or severely debilitating illness or condition for which there is substantial evidence of clinical effectiveness that the drug provides: effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada | Breakthrough=first drug product to treat effectively a particular illness | Bravo=major therapeutic innovation in an area where previously no treatment was available A real advance=product is an important therapeutic innovation but has certain limitations Offers an advantage=product has some value but does not fundamentally change the present therapeutic practice |
| A serious, life-threatening or severely debilitating illness or condition for which there is substantial evidence of clinical effectiveness that the drug provides: significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies | Substantial improvement=provides a substantial improvement over existing drug products |