The Canadian Common Drug Review (CDR) was established in 2003 to provide a single process for making formulary recommendations to most Canadian, publicly funded drug plans. This paper considers the most common challenges faced by the CDR:
a) Determining the effectiveness of a drug (particularly interpreting the importance of surrogate markers and changes in quality of life measures);
b) The massive rise in the cost of new drugs, which, in general, does not seem to be accompanied by a massive increase in effectiveness;
c) Interpreting complex pharmacoeconomic evaluations, which often do not provide straightforward answers about the cost effectiveness of a drug;
d) Prescription creep (the tendency for drugs in the "real world" to be used in patients who were not studied in clinical trials, thus raising concerns about a drug's real-world cost effectiveness); and,
e) Ethical and societal issues, particularly the reimbursement of expensive drugs for rare diseases.