Geoff Sprang correctly notes that the use of traditional Health Technology Assessment (HTA), including a formal systematic review of the clinical evidence (safety and effectiveness in comparison to current care), and consideration and critique of a manufacturer-provided economic evaluation, provides the backbone for the evaluation of drugs within the Canadian Common Drug Review. He also notes that traditional HTA does not have a formal framework for considering other aspects of a drug that are important to consider during the reimbursement process, including the severity of the disease condition, whether there are any other treatment options for the condition in question, and whether the condition is rare or common (among other considerations).

As others have proposed, Geoff proposes that the Canadian Common Drug review should implement a formal process that considers these other factors, to reduce the subjectivity in drug assessment. As he notes, these factors are already considered informally for all drugs reviewed by the Canadian Expert Drug Advisory Committee (CEDAC), and a conscious effort to increase consideration of these factors was made when public committee members were added to CEDAC in 2006.

While the quality adjusted life year continues to be a lightning rod for criticism (and undoubtedly always will be), it remains a reasonable proxy for what health care systems are trying to achieve (maximizing life expectancy and quality of life), with uncertainties around its measurement often relating mostly to inadequacies in the clinical data that exist at the time of drug submission. Similarly, there are many issues with multi-criteria decision analysis, including what other factors to consider and how to reduce subjectivity in item measurement. Relating to the comprehensive value assessment scheme offered, inclusion of “innovation” adds an additional dimension of complexity since the definition of innovation differs between decision makers and manufacturers. Most health care decision makers consider innovation in terms of whether a drug offers improvement in either life expectancy or other measures of health compared to treatments that are currently being used (both of which are incorporated into traditional HTA) whereas manufacturers often consider innovation to reflect a drug’s mechanism of action or delivery method.

It is clear that recommendations made by drug reimbursement committees vary across countries (even for the same drugs)1, though it is less clear whether this is due to differences in the drug plans supported, different interpretations of the clinical or cost-effectiveness evidence, or relates to different interpretations of these other subjective factors noted above. Given that these factors will always remain subjective, even when codified, the true test of the value of frameworks like multi-criteria decision analysis would be to determine whether funding recommendations differ (or become more consistent across countries) if a formal framework to facilitate comprehensive value assessment were incorporated into decision making. Given the complexity of the decision-making process, and reliance in the end on experts in the field, necessitating expert committees like CEDAC, I suspect recommendations would not change substantively.

Reference:
¹ Clement FM, Harris A, Li JJ, Yong K, Lee KM, Manns BJ. Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA 2009;302:1437-43.