Not all guidelines are created equal

I have read with interest the recent editorial criticizing the Canadian Diabetes Association (CDA) Clinical Practice Guidelines (CPGs).¹ I am one of the few physicians who have served on both clinical practice guideline groups and drug review panels (in my case the CDA and Canadian Hypertension Education Program [CHEP] guideline groups and the Ontario Drug Programs Branch Pharmacoeconomic Review Committee respectively). The mandate of guideline groups and drug review panels differ so extensively that one should expect that their respective conclusions will often differ. Guideline groups advocate use of the most effective therapies as suggested by the medical literature, and typically do not perform economic analyses when generating guidelines. Drug review panels determine whether a new therapeutic is sufficiently cost-effective and has an acceptable budget impact within the context of their jurisdiction. There are 4 primary reasons why guideline groups do not (and in my opinion should not) perform economic analyses when generating guidelines. First, guideline groups do not have a mandate from any provincial or federal agency to make decisions about what therapies will be publicly funded. Equally important, they have no mandate to recommend removal of currently funded therapeutics when the cost-effectiveness of care would benefit from such an action. Second, guideline groups are not provided projected budget information that would help inform an economic assessment. Third, one could consider an assessment of effectiveness to be somewhat “universal.” In contrast, the determination of whether a therapy is acceptably cost-effective can certainly vary between jurisdictions. Finally, an economics based approach would place guideline groups in a true conflict of interest between their patient advocacy role and their obligations to the health care payors. It is important to recognize that the quality of the health economics section of a company's approval application could be lower than the clinical section, which could affect the subsequent conclusions about the drug.

The roles of guideline groups and drug review panels are both necessary and complimentary. Recognizing that the most effective therapies will not always be the most cost-effective leads to the appropriate expectation that guideline groups and drug review panels may reach opposite conclusions. The potential for dualities of interest is real, and guideline groups have processes in place to allow for declarations of potential conflicts. Making these declarations accessible to reviewers is a reasonable request. I would also suggest that making available the guideline's technical documents would be helpful in explaining how a literature review led to a specific guideline, and would mitigate criticism that self-interest motivated particular recommendations. CPGs are an essential resource for clinicians. Allowing reviewers to be aware of potential conflicts of interest is reasonable. Excluding publication of guidelines because potential conflicts of interest may exist is not.