The pan Canadian Oncology Drug Review (pCODR) was formed to support a nationally uniform cancer drug review process. Committee members are asked to weigh clinical and economic evidence, as well as other considerations when recommending a cancer drug to the public formulary. The pCODR has identified the need for a procedural guidance tool for use in the decision process. We will develop a conceptual framework and a guidance tool to support consistency. We will use mixed methods, including qualitative interviews with knowledge users and knowledge producers, quantitative exercises, an intensive roundtable consultation, and online iterative feedback, to ensure that our results are relevant to the pCODR and Canadian decision-makers.
The gap we will address for Canada is the absence of a clear, agreed upon guidance tool informed by documented barriers between knowledge producers and users, and context-sensitive models of knowledge translation.
Goals of the AFFORD project
- To characterize the challenges with using multiple types of evidence (e.g. clinical, economic, patient preferences, budgetary) in the review of drug dossiers.
- To describe the needs of formulary committees with respect to meaningfully using multiple types of evidence.
- To identify potential policies and knowledge translation strategies that to improve/ facilitate the meaningful use of multiple types of evidence.
The AFFORD study is a mixed-methods study. It combines qualitative analysis with a quantitative stated-preferences elicitation. The preference elicitation is informed by a completed qualitative pilot study funded by the Canadian Centre for Applied Research in Cancer Control (ARCC). The results of the stated-preferences elicitation will be triangulated with qualitative results to develop the final outcome. The AFFORD study builds on the ARCC funded proof-of-principle pilot study (see the Our Research page for more details), expanding the research design and increasing the sample size.
Component 1: State-Preferences Elicitation
Choice-based stated preference methods are used to quantify the relative impact of different attributes in a funding decision, including economic, clinical, and other types of evidence, and to derive how different levels of these factors may influence funding decisions. To address these objectives, we are using Best-Worst Scaling nested within a binary Discrete Choice Experiment.
Stated-preference techniques are based on the idea that although people may not be able to provide direct values or weights, they are typically able to indicate which good or scenario they prefer. Discrete choice experiments (DCEs) ask respondents to identify their preferred choice from alternatives described in terms of specific attributes and levels. DCEs encourage respondents to consider trade-offs and opportunity costs.
The proposed DCE presents a series of binary choices between funding and not funding specific hypothetical cancer therapies. Each therapy is described in terms of relevant attributes and levels (e.g., high, medium, low illness severity; number of life years gained; cost-utility ratio).
Attributes included in the elicitation are based on the literature and the results of the ARCC-funded pilot study qualitative interviews with decision makers. In the pilot study, the following attributes were examined: clinical effectiveness, extension in life, adverse effects, cost-utility, the quality of clinical and economic evidence, budget considerations, rarity of disease, availability of alternative treatments, and average age of the patient population.
Component 2: Qualitative Interviews
In the AFFORD study, qualitative interviews will reveal how economic, clinical and other evidence is understood and the process by which it is used in decision making. Thematic qualitative analysis will be applied to identify the challenges associated with the use of economic, clinical and other evidence, as well as potential improvements. Participatory consultation and qualitative iterative analysis will be used in the development of a procedural framework for the production and use of economic evidence in the multi-criteria decision making context.
Qualitative interviews will be held with economists and health services researchers (producers of knowledge) and decision-makers (users of knowledge) to describe their understanding of the role and use of economic analyses in combination with clinical and other evidence. Thematic analysis will be used to characterize the issues highlighted by the producers and users of economic evidence. Thematic analysis will focus on predetermined dimensions (priorities, objectives, sequencing, timing, information needs and availability, and applicability), however new dimensions may be added to accommodate the data.