Table 1.
Health Canada: criteria for priority review and NOC/c pathway | Human Drug Advisory Panel of Patented Medicine Prices Review Board: – criteria for breakthrough and substantial improvement | Prescrire: criteria for bravo and a real advance |
Priority review: 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 |
NOC/c pathway: provides patients suffering from serious, life-threatening or severely debilitating diseases or conditions with earlier access to promising new drugs | Substantial improvement: provides a substantial improvement over existing drug products | A real advance: product is an important therapeutic innovation but has certain limitations |
Adapted from.24
NOC/c, Notice of Compliance with conditions.