Methods: A paradigm is a constellation of beliefs, values, and techniques shared by members of a community (Kuhn). Decision making in the committee is evolving along three scientific paradigms. We describe how these paradigms shape both criteria and process of decision making. We also systematically reviewed meeting transcripts to see how decisions in 2006 were determined by these ideas.

Results: Evidence Based Medicine (I) is part of decision making through rigorous evidence reviews and the implicit rule that drugs must pass the threshold of effectiveness to be funded. Although drugs have to pass one evidence threshold to be licenced in Canada, distinct and higher evidentiary standards are required for reimbursement (e.g. phase III controlled trial data, peer reviewed publication, clear balance of benefits over harms). Health economic criteria (II) are assuming greater weight in decision making, as the review process is standardized, committee members become more economically literate, and a cancer pharmacoeconomics unit is established. The process of decision making (as opposed to decision criteria) is evolving using the ethical foundations of Accountability for Reasonableness (III), important tenets of which are transparency, accountability, and stakeholder involvement in the decision process. Reasons for decisions are being made public and citizens are becoming part of the decision process.

A review of the 2006 decisions showed that 16 of 37 drugs were funded (43%). Among negative funding decisions 86% were characterized by inadequate evidence (the main reason in 43%), 71% were characterized by cost effectiveness concerns (the main reason in 15% ), and 5% by ethical concerns (the main reason in 5%). 48% of decisions were multifactorial.

Conclusion: Each paradigm used to make cancer drug funding decisions comes from a distinct intellectual tradition. Most decisions made in 2006 were based on more than one paradigm. We believe that optimal decision making for cancer drugs involves integrating concepts from all traditions, involving both distinct decision criteria and decision processes. Integrating these ideas requires judicious tradeoffs between not only efficiency and equity, but also between evidence quality and efficiency/equity.