Common drug review recommendations for orphan drugs in Canada: basis of recommendations and comparison with similar reviews in Quebec, Australia, Scotland and New Zealand

John I. McCormick, L. Diana Berescu and Nabil Tadros; Orphanet Journal of Rare Diseases201813:27 doi:10.1186/s13023-018-0759-9


The positive recommendation rate for CDR reviews of orphan drugs was highest when both clinical and price parameters formed the basis of the assessment. However, there was a change in CDR review policies in 2016, with a dramatic increase in the number of positive recommendations, the majority of which were conditional on a substantial reduction in drug price. This change in CDR recommendations is reflected in the expanded criteria and conditions of drug reimbursement outlined in CADTH’s March 2016 recommendation framework. However, it remains to be seen if this represents a permanent change in how CDR reviews orphan drugs and if this will result in wider and more timely provincial access for orphan drugs for patients throughout Canada.