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.

Thank you for your quick response!

@lilymcneil These questions may be acceptable if the content, context, and link aligns with the general guidance provided in our prior response. Of course, copy specific guidance would be provided as part of the review process. Questions and responses need to be assessed in the context of the entire piece and with assessment of the references.

@akar Great question. Note that any of the proposed content would require review under the PAAB code. This is occasionally a point of confusion in the generic space. If the generic product’s TMA refers to the innovator brand as the reference product, the generic manufacturer may convey this fact in the APS. For example, “… generic version of Drug X [the reference product]”. In the unlikely event that the reference product is no longer authorized for sale, this should be conveyed through a cross-reference to the claim above. However, a manufacturer should only discuss the availability status of its own products. For example, it would be unacceptable to comment on a competitor’s drug shortage issues. Any messages relating to switching will require support from the TMA or standard setting organizations.

We’d need to assess the methodology through which the data was collected and analyzed through the third party research company. Ultimately, it's possible but unlikely since adherence is quite difficult to measure. It is important to distinguish between adherence and retention. Often when folks say the former, they are actually referring to the latter. PAAB interprets compliance/adherence as the extent to which patients administer the medication as instructed by the HCP. This is in contrast to persistence / retention which PAAB interprets simply as continued dispensing of the prescribed medication. It is inherently difficult to reliably measure patient adherence / compliance. We have yet to receive acceptable third party data that supports comparative adherence claims. However, PAAB regularly considers persistence / retention data from recognized or validated claims-based market data providers. The data may be comparative if it is less than 6 months old. Inferences (like “Drug X demonstrated higher retention rate vs drug Y”) may be made if supported by statistical significance.