I read with great interest the paper by Geoff Sprang entitled :”Traditional reimbursement decision-making misses the big picture”. The drawbacks and flaws of $/QUALY, so dear to Canadian Health Technology Assessment, are too numerous and too well recognized to deserve further listing. This does not mean it should be totally abandoned since, at the very least, it will provide a frame of reference on which to measure potential alternatives. An interesting alternative is the Comprehensive Benefits of Value (CBV) acting as a modifier of the Cost-effectiveness threshold (CET).

The currently used CET is a mythical figure that is often discussed but very rarely officially defined. The ongoing rumor being that it corresponds to the cost/QUALY of hemodyalisis. This makes sense given that a society willing to pay for hemodyalisis should, to be consistent, pay for interventions with lower costs/QUALY. Besides all the problems inherent in the quantification of the cost/QUALY of a specific intervention one should realize that the CET should be continuously (almost in real-time) adjusted to the value of the highest cost/QUALY technology reimbursed by society at the moment of the evaluation of the new intervention. Furthermore, from a practical point of view, more often than not the CET sits somewhere between the highest and the lowest value of the cost/QUALY produced by the sensitivity analysis.

The proposal to use the CBV to adjust the cost-effectiveness threshold has considerable merit. As a matter of fact it is just a formalization and systematization of a process that has been ongoing for at least twenty years. How else can you explain the fact that given the same cost/QUALY value the drug reimbursement decisions made by different Canadian provinces show such a high degree of divergence? It is quite obvious that informally, almost subconciently, they have been applying a modifier to the cost/QUALY information they receive. This modifier will vary from province to province. When I look at the components of the CBV total score I recognize most of the factors that are informally taken into consideration by Canadian provincial drug-reimbursement organizations.

I strongly believe that attempts at quantification are a good thing, as long as they are followed by a formal evaluation. The components of the proposed CBV are comprehensive and I do not see a need for additional parameters. One still faces the daunting task of assigning weights which are proportional to the “value” of the component and the quality of the evidence on which it is based. In my experience the members of drug reimbursement advisory committees give a high value to innovation and tend to disregard patient convenience. I am not convinced that patient representatives would arrive at the same conclusions. Which leads to the question: who should participate in the exercise and which mechanism should be used? The following challenge would be the validation of the CBV given the fact that there is no gold standard. At worse we would end up with terms of reference that would certainly make the process better structured and hopefully more transparent.

In spite of the huge challenges, the present process is too unsatisfactory, and the stakes too high, for us to continue being complacent and to persist in using a methodology in which must of us do not believe. The Amgen proposal has the merit of providing a basis to at least initiate a long overdue discussion which should focus on how to best serve the patients interest.