743 - Hi PAAB, I was wondering if expert guidelines for treatment option algorithms (first line, second line) are allowed to be included in branded pieces directed at HCPs. The goal would not be to compare treatments but to see under which situations / for what patients a therapy would be preferred. (Patient profile?) Thanks for your help!
Jennifer Carroll last edited by
This question has two parts to it. First, lets address “expert guidelines”. For consideration as evidence to support place in therapy messages, we first look to Canadian consensus guidelines, to ensure consistency with current Canadian medical opinion. In the absence of Canadian guidelines we can consider US or North American guidelines. Please see AskPAAB #593 for more guidance on the use of non-Canadian consensus guidelines. The guidelines must be endorsed or recognized by an authoritative medical body and it should be nationally recognized. It is not sufficient for the guidelines to simply be published and peer-reviewed. With respect to off-label content, guidelines cannot be used to support treatment recommendations which extend beyond a product’s monograph.
The second part of this question relates to the content in the APS which the guidelines are intended to support (i.e. “see under which situations/ for what patients a therapy would be preferred”). We can consider guidelines to support claims related to “place in therapy”, however patient selection may entail broader topics (e.g. concomitant conditions, age, gender, etc.). Selection of one first-line product over another generally suggests comparative significance, for which consensus guidelines would not be an acceptable source.