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Hi. Would there be any concerns with inclusion of a claim that references a vaccine product being publicly funded in a branded DTC APS, in terms of language along the lines of: “Now available free of charge in some provinces. Speak to your doctor to see if X is covered for you.” or “Now Publicly Available in Canada. Speak to your doctor to see if X is covered in your province.”

If an unbranded help-seeking website for a DTC audience has been previously ASC approved, and tools that drive consumers to the site are developed for use in HCP waiting rooms/offices and submitted to the PAAB for review, will the PAAB accept the standing ASC approval of the DTC website? Or would the website be required to be resubmitted to the PAAB for a full review, on the basis of the fact that it's referenced within the APS submitted to the PAAB for review? Audience would be the same (consumers) for both the website and the tools being developed that drive people to the website.

In context of this question, we are well aware of this newsletter reminder: https://www.paab.ca/resources/targeting-consumer-materials-to-patients-through-healthcare-professionals/

And this associated guidance document: https://www.paab.ca/resources/advisory-aps-in-patient-interaction-areas/

Waiting rooms in HCP offices are not defined within this guidance. Is there a difference in the answer to the above question between APS utilized in general waiting rooms vs. in HCP/patient interaction areas such as exam rooms, in terms of the mandate for PAAB review and also the acceptance of the standing ASC approval on the existing website?

Hello! A client has asked about whether a message that summarizes the percentage of Canadian lives covered by private insurance for a particular product (without mention of disease state or indication) meets the exemption criteria around formulary messages?

Our client has asked for confirmation as to whether a statement of “Another indication for Product X is now on formulary in province X" (not linked in any way to additional product messages and/or any mention of therapeutic area) meets the conditions of exemption for formulary announcement messages.

Our client will be developing materials for an unbranded education program, with the intent to provide disease educational tools to a nurse who will utilize them in counselling IBD patients who have been referred from a GI for additional disease education. There would be some balanced information around available treatments within this content.

In terms of how these materials would be submitted to PAAB for review, would they be classified as a DTCi review (given they are unbranded and intended for people with IBD who have not been prescribed any particular prescription therapy)? Or would they be considered unbranded "patient" materials?

Our client has asked us to seek official confirmation from the PAAB on the direction we are providing.

Is it permissible to include a callout in a branded APS that simply mentions a positive LOI with pCPA for a particular indication, once that agreement has been publicized? Appropriate balance information would be included.

Can you please clarify what the manufacturer's responsibility is regarding updating approved APS when a new boxed warning has been added to a product's TMA? Does this need to be done proactively, i.e., materials updated prior to expiry? Or can they be updated as each piece expires?

If a client wants to create an email that generally updates HCPs on the status of a CADTH recommendation/public reimbursement for a product, would this be an acceptable message for such an APS? Idea is that message would simply be along the lines of: "Company ABC" has submitted "indication" for public reimbursement. Both CADTH and INESSS have published positive recommendations for patients that meet the criteria of the new indication. The next step in the process is negotiations with pan-Canadian Pharmaceutical Alliance (pCPA), which takes an average of approximately 12 months. Once the negotiation is successfully concluded, product listing agreements need to be entered into with each province. This can take up to several months depending on the individual province." The email would also contain low level fair balance (indication statement, etc.), given that the product indication is referenced. Are there any concerns with the proposed content of such an email? The email would not link to the actual CADTH recommendation letter itself.

Thank you @Jennifer-Carroll. Appreciate the additional clarification. Helps to have this in writing for alignment across various stakeholders.

Hi @Jennifer-Carroll. Thanks for the response. To clarify, the intent of the 1x1 email from a rep to a physician is not to send/attach a PAAB-approved APS, nor to create a pre-drafted email that has open text fields.

The question here is whether a rep could simply send a personal email to a physician (as per PAAB code 1.5, B, and the reference that "Person-to-Person Correspondence" is not subject to pre-clearance) that makes reference to there being a new indication for a particular product.

We understand that reference to a "new indication" is a claim, that warrants low level fair balance and a submission for PAAB review.

However, how does the exemption regarding "person-to-person correspondence" relate to this? What supersedes here?

Thanks @Jennifer-Carroll!

We’ve been seeing some conflicting information between various sources around whether a rep can include mention that there is a new indication for a particular brand in an email that they send on a 1x1 basis to a healthcare professional that they have relationship with, when they’re requesting scheduling a virtual meeting time (i.e.in Veeva Engage) to discuss further. Given current COVID-19 realities, a rep no longer has the opportunity to be live in a physicians’ office and verbally make mention to them of a new indication and then launch into a further discussion using PAAB-approved APS. So they’re hoping to be able to make mention of the reason they want to schedule an appointment with a physician in that email that they’re sending to book time to discuss virtually.

The email would be a true one-to-one email, and not a pre-drafted email intended to be sent to multiple HCPs where the rep is simply personalizing a greeting line or something of that nature.

Possible to provide clarification?

Our client would like to develop a tool that presents a text based side-by-side comparison from two product TMAs on instructions for use limitations (i.e. warnings & precautions). We understand that we have to make the comparisons representative of the section of the TMA that it is based on and not selective to which attributes are included, but a piece that presents the entire warnings & precautions section for each drug would be extremely long. We’re aiming to understand if we can make comparisons of just specific sub-sections of the W&P section (for example a sub-section under a “Cardiovascular” subheading, and then be complete about covering everything within that particular section for both products), versus having to include the entire W&P section?

We would, of course, ensure that a disclaimer is included that denotes that clinical significant is not implied, and that there is no heading that implies an overall comparison of safety.