Good morning @gmc

PAAB has issued advisories and guidance regarding formulary claims since 2010. In addition, we have received feedback from formularies regarding the presentation of formulary coverage in APS since then. The 2010 eFile may not reflect the more recent information and should not be used as precedent. We suggest submitting for an opinion should there be more specific questions regarding the proposed project.

Hi @abyscat,
In general, if a specific coverage criteria is broader then the product’s indication or terms of market authorization, it is considered off-label and not acceptable in advertising. We suggest calling PAAB or submitting an opinion if there is specific formulary criteria that may require further clarification.

Hey @charlton

No, a patient case is not required to be on a patient who actually participated in the PM trial.

Hey @kshulist

This sounds like a specific question about a specific file and issue. It would be best addressed by discussing the specifics of the request with the reviewer of the file, in the context of the actual claim and indication, particularly since there are additional considerations for exclusivity claims.

As a general principle, claims with the phrase “…indicated for…” require the verbatim indication, whereas non-verbatim/truncated indication claims may appear as “…indicated in…”. A “first and only” claim like that described, would appear to be an indication comparison and therefore require the copy “indicated in/for”.

Good Morning @username

To set the context of the response, please see Q&A 500 . If the copy falls outside of the scope of the PAAB code, we can provide an advisory response on content. To support instructions for a demo device, we could consider a letter from medical confirming that the instructions are accurate per how they would counsel an HCP should they contact medical for directions on use. No copy should contradict the product labelling or package insert and clinical conclusions should not be inferred.

Hey @username

In the context of a study design, with no additional weight that would emphasize the endpoint, it would likely be acceptable to mention the endpoint.

Hey @tmcm

The nature of the dosing modifications and the manner in which they are presented, will impact the level of fair balance. A dosing tool with cautionary dosing modifications may be subject to the lowest level fair balance. If the modifications are positioned as a product benefit it will likely require highest level fair balance.

Hello @tmcm

I’m going to assume that you are asking if this is acceptable to do. Key things to consider are that the formulary criteria should be a complete presentation of the coverage criteria (s.2.1), so a summary presentation would have to be considered complete on the face of the ad (the link to the full coverage would not be sufficient). Additionally, highlighting specific patient characteristics may be viewed as placing emphasis on those characteristics, which may require support. Similar concerns may arise with highlighting specific prior drug treatments. We would need to consider the specifics of the drug and the coverage criteria to determine if the summary is sufficient. Q&A 258 provides additional information as well as the advisory document Provincial Formulary Coverage Statements

Good morning @georgian21

When there are Canadian consensus guidelines, HCPs should be directed to those. As per the document “What constitutes current medical opinion & practice”, US or European guidelines can be used as additional support to Canadian guidelines when they are consistent. If there is copy that goes beyond the recommendations of the Canadian guidelines, or contains products not yet approved in Canada, we would question the inclusion.

Good Morning @username

The overall context of a piece is always part of the consideration. Acceptable copy should be factual and complete. The copy “Back in Canada” on it’s own would not be clear or complete. It’s unclear why it was not in Canada? Similar questions would arise with “Available again to Canadians”. This copy completed with “after a voluntary recall” may be considered.

Hello @healthymind

This question cannot be answered as a general question. We would need to assess the TMA content, claim and data within the published study. We suggest submitting as an opinion for a formal review.

From a general question perspective, we refer you to the PAAB Guidance on Patient Reported Outcomes which outlines specific considerations for PRO, including specific domains/items comprising the PRO instrument.

Happy Friday @username

The PAAB interprets “pivotal trial” to mean that the study was important to this specific product getting the indication (not necessarily important to the therapeutic area overall).

Hello @username

Code section 1.4c states “The Code applies to Advertising/Promotion Systems generated by advertisers or their agents, wherein the advertiser’s product or a competitor’s product is cited by either trade name or non-proprietary name. This includes any identifiable branding element.”. As such, the dosing for products which should be used in combination with the sponsors product, are required to be aligned with their respective TMA. If the products label does not align (i.e. not indicated in the specific population of reference), the sponsor should limit the copy to directing the HCP or patient to the respective labelling of the products which can be used in combination.

We could provide a more specific assessment in the context of an official opinion submission, providing consideration to all factors that pertain to your particular case (e.g., precise wording in monograph, planned level of specificity of provided dosing info, particular references intended to be cited, and so on).

Hello @healthymind

The references should be provided for all HCP material so that the HCP has the information required to assess the credibility of the message themselves. The reference list (including provincial formulary citations) should be adequately disclosed within the piece or on a weblink destination if the sponsor chooses. If the sponsor is concerned about space and redundancies, we can consider a reference similar to “Data on file: Brand X Coverage Canada. Manufacturers Name. Date”. The exception to this, is for Quebec formulary claims, as the Régie de l’assurance maladie du Québec (RAMQ) has requested the link destination appear on the surface of the ad. See Advisory Regarding Use of RAMQ in APS

Good afternoon @tmcd

Yes, assuming that you are speaking to the average out-of-pocket cost that the sponsor’s Patient Support Program will cover for eligible, enrolled patients. Note that it should be specific to the sponsor’s product and that a range (min-max) would be required to also be included (in the attestation and on the face of the piece), so as to be clear and complete

Good Morning @gbrl88

Apologies for not seeing this sooner. Thank you for bringing this document to our attention. This informational piece was put out while we were discussing proposed changes to the use of RWE. However, the proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising. As such, we will be taking the document referenced above, down.

As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.

Hello @tmcd
If the video is to always be part of the IVA and never shown outside of the IVA, it is fair to assume that the fair balance and logos do not have to be incorporated into the video itself, if it is sufficiently captured in the IVA (i.e. minimum middle level fair balance). When submitting, the IVA should be included in the submission, with clear instructions on the incorporation into the IVA (i.e. placement, access, any additional functionality accorded to the video or IVA to access the video).

Hey @llmktg

As a general guidance, advertising material must be consistent with the TMA and be supported by quality references. No copy, content or linkages should suggest that the product somehow helps to manage/prevent/detect COVID-19 infection that extends beyond the TMA.

With that in mind, any specifics about the disease (COVID) should be directed to the homepage of groups considered to be authoritative sources, such as the WHO and Public Health Agencies for disease information. As the product is not indicated for COVID and it is not likely that there is COVID specific messaging in the TMA, it may be misleading to present this information on the branded website. It could house links to acceptable resources, and house material on practical information, e.g. virtual appts, mask wearing etc. clearly separate from any branding messages or content. The sponsor should ensure separation is done in a distinct manner so as not to suggest that the sponsors brand addresses the condition.

When we start to get into how comorbidities interact with the condition and it’s treatment or the treatment the patient is on, the evidence requirements are subject to statistically significant data from high quality studies per our usual review.

Hey @Sil

Evidence not presented in the TMA can be considered in pieces when it is consistent with the TMA and supported by statistically significant, high quality data of predefined study endpoints from a published and peer-reviewed randomized control trial (s.5.9). You have correctly identified some key features we look for (i.e. same indication, consistency with outcome type) along with other things such as comparable dosage strengths or blinding. A key document on the PAAB website which can further assist you in assessing the potential acceptability of the study and claims you wish to make the Marketing benefit claims: what are they and what level of support do they require document. You may also want to check out Subjective versus Objective Endpoints and Guidance on Non-inferiority Trials which speak to consistency with the TMA.