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!

Thanks @Jennifer-Carroll!

Hello @Danielle

PAAB Q&A 387 and 338 cover patient satisfaction, surveys, perception of efficacy, safety, ease of use and preference claims. Please provide us with an example of a “non-subjective satisfaction measure” as satisfaction is inherently subjective (measures an individuals perceived fulfillment of expectations).

The PAAB resource Marketing benefit claims: What are they and what level of support do they require? provides additional guidance.

@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.