Forum

Hi! We are interested in using a set of International Guidelines to provide messages about its recommendations and to make place-in-therapy claims about our product. While we note that international guidelines are generally not accepted and that PAAB favours Canadian and American guidelines, over 10 of the authors on these guidelines (including the lead author) are Canadian. Furthermore, because these guidelines are for a rare disease, there is no Canadian authoritative medical body that focuses on the disease, so getting "endorsement" from such a body may be difficult. Given these circumstances, would PAAB be a bit more flexible regarding the use of these guidelines?

Hello! We have come across multiple retrospective cohort studies that could potentially be used in APS, thanks to PAAB's Guidance on RWE. One issue that has come up for a couple of these studies is the lack of dosing information, which is required to fulfill 1.1.3 of the RWE Guidance. We believe that it is common for specific dosing information to be omitted from these studies, but think that it is fair to assume that a large majority of the patients would be dosed based on regional labels (e.g., SmPC, US PI). For such studies where dosing information is not available, can we simply cite the regional label?

Another consideration for a couple of these studies is the use of a "SoC" comparator pool, in which of some of the SoC treatments lacka Health Canada-approved indication that aligns with the study. Would this contravene 1.7 of the RWE guidance?

Thank you for your help!

We have seen older APSs that present AE rates (in copy or in the form of a table) using a higher incidence threshold than what is used in the PM. For example, the PM's AE table shows all AEs that occurred in >1% of patients, but in the APS, the table only includes the AEs that occurred in >5% of patients.

Does the PAAB allow this in newer APSs?

On one hand, we understand that this shortens the list of AEs, which could be contentious. On the other hand, the presentation is still accurate and clear if it discloses the threshold that is used (e.g., AEs that occurred in >5% of patients).

Thank you! Based on the last sentence of Q&A you've mentioned, we can still present AE data from an acceptable clinical trial, even if the data do not exist in the TMA. However, special attention must be given to ensure that the presentation is neutral and noncomparative, and that the AE rates are "roughly" aligned with those of the TMA.

Does it make a difference if the comparator is included or excluded from the presentation?

Hello,

We wanted to clarify the requirements for including safety data (adverse events rates) that are not included in the PM. A PM can include an AE table for a particular study, but in some cases, certain AEs from the study may not be included in the P. .

We would like to present these additional "out-of-PM" AEs, and while there is no statistical analysis for these data (which is common for AE rates), we note that these AEs of interest were predefined, and that we are amenable to presenting the data in a claim-neutral manner, either with or without the comparator.

The rationale is as follows: When AE rates are particularly low, they may not appear in the PM. However, they may still come up in rep-to-HCP conversations if they are relevant in the therapeutic area. Therefore, it should be reasonable to include this information in an APS, especially if it is presented in a claim-neutral manner that does not impart a benefit from the drug.

@jennifer-carroll Hello! We're wondering how this ruling applies when the extension study results for a NOC/c product are described in the PM, but the data are omitted from the PM. This is commonly presented in the PM as "the results of the extension study were consistent with those of the earlier analysis".

The quote from the Guidance states "studies and/or data which are not presented...". In these cases, the study is presented in the TMA, but the the data are not. The way the study is presented also implies that the results were favorable (since they aligned with the earlier analysis). Can we include the study data in this case, and if so, would it be able to be presented in a promotional manner?

Hi! How do we go about developing an APS for a prescription schedule product that does not have a Product Monograph? The main content cap is the development of the fair balance (including the indication, and a link to a PM). Thanks in advance!

We were wondering if there was any guidance on the use of hashtags in unbranded digital media ads (e.g., LinkedIn, Twitter, etc.). We are particularly interested in broad disease awareness hashtags (e.g., #DiseaseXResearch; #DiseaseXAwarenessMonth) and hashtags that include corporate names (e.g., #CompanyZ, #CompanyZTherapeuticAreaY)

Since user-generated content on a sponsored property can impact compliance, we wanted to ask for guidance on whether such hashtags are generally permissible, and what best practices are recommended to ensure compliance in unbranded campaigns.

Thanks in advance!

When PAAB asks us to confirm that there are no exclusive rights to ad placement for digital media/banner ads, what does this entail? Let's say that an HCP-gated web page has 3 spots/positions for digital ads. Is it possible for our client to purchase 100% occupancy of position "A" for 1-2 months, given that positions B and C can still be occupied by other advertisers?

@jennifer-carroll Thank you for clarifying these points. Highly appreciated.

@jennifer-carroll Thank you for your response!

Based on what you've said, it sounds like we need to look to the Health Canada consumer regulations, which I interpret to be the bulleted list of items that could render "Medical condition and treatment awareness materials" promotional (from the July 2023 HC guidance).

If the Unbranded Website is considered promotional based on this bulleted list, this means that it needs to be restricted to an HCP audience (and thus gated). Please let me know if my understanding is correct. Health Canada's guidance helps identify whether or not activities are "promotional", but the consequent implications are not always clear.

@jennifer-carroll

I've heard conflicting advice about website gating for Unbranded HCP Websites.

Does the guidance above still apply to Unbranded HCP APS Websites?

What about Unbranded HCP Websites that are PAAB-exempt (no mention of drug therapy)?

A previous forum question (https://forum.paab.ca/topic/2497) indicated that controlled distribution of a deindexed URL would be considered as an acceptable gating mechanism for an HCP unbranded website. I imagine that this still holds true, since it aligns with D9 of this guidance (so long as the URL is not easily guessable, which is likely the case for an unbranded website).

Appreciate you shedding some more light on this matter!

Hello! 2.4 of the Guidance on Branded Patient Information discusses how differential diagnosis information can be presented in a Branded Piece (even though such information would be discussing conditions for which the Product does not have an indication).

Does this still hold true for branded HCP pieces? Or would this content only be permissible for HCPs in unbranded pieces?

@jennifer-carroll Thank you !!

@jennifer-carroll If the demo kit does not contain any instructions and consists only of a box and the demo device, is it still subject to review? Thanks in advance!

@jennifer-carroll Do these requirements about the sponsor's lack of involvement also apply to non-comparative patient satisfaction claims about Patient Support Programs (as discussed here: https://code.paab.ca/resources/Tips_on_Claims_Relating_to_Patient_Assistance_Programs.pdf)

@jennifer-carroll Thank you for clarifying!

Is it acceptable to visually identify revisions to coverage criteria (e.g., removed criteria bullets, revised duration of approval numbers, etc.) with elements such as strikethroughs, arrows, highlights, bolding, etc.? Could such revisions also be called out in text? (e.g., "there is no longer a requirement for previous systemic treatment").

Presenting updated coverage criteria without calling out the specific changes from the previous criteria could leave our audience confused as to what has changed.

Similarly, could similar visual elements or text callouts be used to identify changes to a product's indications or warnings?

@jennifer-carroll Thank you for the clarification, Jennifer!

Would it be permissible to include a matching-adjusted indirect comparison (MAIC) study (between Product X and a competitor) as an attachment/download in an APS? Or would this type of publication automatically contravene PAAB code?

We note that 5.7.1 discusses how PAAB does not allow the use of PM-PM or study-study comparisons of efficacy and safety due to cross-trial differences. However, use of MAIC is shown to reduce or remove cross-trial differences.