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Hi there,
Could you please provide me with some clarity around "prognosis"-type claims in a branded APS. For example, claims like, "People with diseaseA associated with mutationB have a worse prognosis" or "The five-year survival rate of disease A is 40%". (In the first example, the drug would be indicated for patients with diseaseA associated with mutationB).

My questions are:

1. Can you use these types of claims in a branded sense as long as they are clearly portrayed as "disease information"? And follow-up: would it depend on whether the product has OS data or not?

2. These feel like they might fall under the burden of disease guidelines, is that correct (I'm thinking it could be "sequelae")? The BoD guidance says that sequelae for which the product has no data should not be emphasized - does that mean we can still mention them in an unemphasized manner?

3. If you can use them in a branded sense, what kind of reference support do you need for them? If (2) is correct, would the references be the same as for burdens in section 3 of the BoD guidance?

Thank you so much for your help!

Hi there,
I gather from Question 99 (https://forum.paab.ca/topic/247/99-does-paab-have-specific-rules-regarding-pre-noc-communications?utm_source=chatgpt.com) that you may discuss unmet needs in a unbranded sense as long as you are not being disparaging to other treatments nor pointing to a specific treatment.

My first question is whether you can discuss unmet needs in a branded sense? My assumption would be (following the logic of Question 99) that you cannot discuss unmet needs in a branded sense because the branding would inherently point to a specific treatment (even if you are careful with the copy). Is that correct?

My next question is could you discuss unmet needs in a branded sense if the drug is the first ever (and only) treatment for a condition? In this case, there was a clear unmet need (there were no treatments), now there is a treatment option, and there are no other treatments to disparage or 'point away from'.

Thanks so much for your help!

Hi there,
During the PAAB 2.0 training (I attended the live virtual sessions in 2020), we discussed how it was acceptable to link out from branded pieces to homepages of websites (e.g., CDA homepage), but not to subpages or sections of the website (unless they were submitted for a PAAB review in the context of the brand). The concern we discussed was that the subpage may go beyond the limitations of the product, while directing to a homepage allows the HCP to explore the site as they like.

This leads me to my question: are we allowed to link to subpages or sections of a website in an unbranded patient sense? In this case, there is no product limitations that the subpage could go beyond. If this is not allowed, could you please provide some insight into the reason why / concern?

The reason we are asking is because some websites, for example, the Government of Canada website, are massive but have a lot of information on 100s of diseases and conditions for the Canadian public. So linking to the GoC homepage is kind of useless for the patient when they are only interested in learning more about a specific condition.

Thank you!

Hi there,

I had a follow up question to the one above re: unadjusted p-values. Do the same rules apply to nominal p-values? I've seen that nominal p-values / nominally significant p-values are unadjusted p-values that are <0.05 - I'm not sure if my understanding is correct. But if it is, then I assume the rules for unadjusted p-values include nominal p-values as well?

Thanks so much in advance for your help!

@jennifer-carroll Thanks Jennifer, this is helpful!

Hi there,

I have a question regarding similarities and differences between branded and unbranded materials. I understand that unbranded pieces must not contain any branding elements (e.g. colours/colour scheme, logos, graphics, images etc), cannot resemble branded advertising in any way (including but not limited to any content/layout presented in such a manner as to create a link with branded material), and cannot be used in conjunction with branded advertising.

My first question is regarding whether it is okay to use the same supporting data for disease information between branded and unbranded? For example, let's say there is a survey that states "72% of adult respondents with moderate AD said they experienced itch multiple times a day". Are we allowed to use this same 72% in both branded and unbranded pieces (assuming it meets the criteria above)?

My second question is regarding similarity of copy. If both an unbranded and branded piece have the same sentence: "72% of adult respondents with moderate AD said they experienced itch multiple times a day" but the layouts/colour/visuals of how this sentence is displayed are very different, is that okay? We are asking because sometimes it's hard to say a sentence like this in a very different way.

@jennifer-carroll Thank you!

Just to clarify I'm understanding you're last sentence of (1) correctly: (let's forget about the second publication) in general, if just the response rates (with statistical significance) are presented in the PM (or a PAAB-acceptable publication of the pivotal trial), then anyone can (likely) use those response rates to calculate ARR / NNT?

Thank you and have a great weekend!

Hi there,
I've read Question 508 from the PAAB Q&A (https://www.paab.ca/ask/question-508/) on NNT and I have a couple follow-up questions:

Question 1: Let's say the pivotal trial publication did not calculate ARR, but does provide the response rates for treatment vs. control (with confidence intervals or p-values). A second publication then calculates NNT from the ARR using the statistically significant response rates from the pivotal trial. Are we allowed to present the NNT from this second publication? I understand that the second publication is technically "post-hoc" but I'm unsure if the same concern about post-hoc bias applies here since it seems like it's just math done on previously existing data.

Question 2: Similar situation to Question 1, however, in this case, the statistics done on the treatment vs. control response rates in the pivotal trial were post-hoc. My guess is since the stats on the original pivotal trial data were post-hoc, we cannot present any calculated ARR or NNT. Is that correct?

Thanks in advance for your help!!

@jennifer-carroll, I had a follow-up question. Would it be okay to link to publications that do not meet the PAAB criteria from an unbranded email? Thank you!

@jennifer-carroll Thanks Jennifer!

Hi there,
In general, can we use branded emails with no claims to link out to clinical trial publications (not included in the PM) that may not pass PAAB's requirements to support efficacy/safety claims (though we are not using the publications to support any claims)?

It might be easier to explain my question with an example:

I understand that to support comparative efficacy and safety claims, publications need to be head-to-head, well-designed, adequately controlled, blinded, randomized. However, let's say we have an open-label H2H (due to different administrations of the drugs) that is not included in the PM. Could we develop a branded email that only says "There was a head-to-head study done" and provides a link to the publication (without any claims at all)?

Or a similar example is for an RTE publication. Let's say the RTE publication would not meet the recently updated PAAB requirements to support efficacy/safety claims. Could we still neutrally link out to it from a branded email ("See a link to recent real world data below")?

Thank you for your help!

@jennifer-carroll Thank you Jennifer!

Hi there,

I'm a bit unclear as to when the "Clinical significance has not been established" footnote is required. I understand in general that it would be required when non-clinical features are implied to have clinical significance, however, I guess I am unclear on what PAAB considers "non-clinical features". I know it includes MoA and (I think) ingredient-related claims (e.g., "Drug Z contains no added chemicalY"), but beyond that, I am unsure.

For example, would a claim like "More than X patients prescribed worldwide" require the "Clinical significance has not been established" footnote? Would that be considered a "non-clinical feature"?

Any help would be greatly appreciated! Thank you very much!

Hi there!

I know that messages of "new" (or "introducing") are limited to one year post-marketing. I am wondering how PAAB defines the date that is considered the start of "marketing"?

For example, Drug X gets NOC on Oct. 13, 2023, however, the first official marketing piece is only released to HCPs (e.g., a "Now Available" email) on Mar. 4, 2024. Does that mean that "new" can be used until Mar. 4, 2025 (since the marketing didn't officially start until Mar. 4 2024)? Or would "new" only be allowed to be used until Oct. 13, 2024 (as per the NOC date)?

If it is based on the date the first marketing material is released (e.g., Mar. 4, 2024), does PAAB required some kind of confirmation letter from the company supporting that specific date as the start of marketing? (e.g., perhaps if a material was submitted after Oct. 13, 2024 but still included a "new" message)

Thank you so much for your help!

@jennifer-carroll, I have another follow-up question related to this. I understand that for all before/after images (real-world patients, AI-generated images, pivotal trial patients) the after results need to reflect the average result from the pivotal trial. Is it enough that the images clearly look like they reflect the average result, or does PAAB require the patient's actual data values to confirm this (for example, the baseline and "after" endpoint scores/values). For real-world patients, doctors may not be as vigilant at recording this info as when they are an investigator in a clinical trial. Thanks so much for your help!

@admin

Hi there, under the subhead "APPROACH FOR PRESENTATION OF RWE/RWD IN APS", the link within the following sentence does not seem to work for me: "For a list of some of the key relevant resources & guidances CLICK HERE."

It doesn't appear to be a hyperlink for me. I've tried different browsers with the same result - could you please advise where that link was directing to?

Thank you!

Hi there,
I have a question related to the (soon-to-be-effective) guidance on disease burden (https://www.paab.ca/resources/guidance-on-the-presentation-of-burdens-of-disease-in-advertising/).

Does this guidance still apply if a drug's indication is for a symptom of a disease?

For example, DrugX is indicated for symptomA associated with DiseaseZ. By default, everyone prescribed DrugX has DiseaseZ. In a branded patient piece, can we educate patients on DiseaseZ with mention of other associated symptoms (symptomB, C, D, E) in a disease info section (assuming these symptoms follow the general rules of the guidance, e.g., widely accepted, related to disease, etc)?

Thanks for your help!

Sorry I forgot to mention that DrugX has not demonstrated an effect for symptomB, C, D, E

@jennifer-carroll Thank you for clearing that up!

Hi there,

I'm looking for some clarity on this PAAB advisory on formulary coverage statements: https://www.paab.ca/resources/provincial-formulary-coverage-statements/

My question is whether formulary criteria (in the case where coverage is restricted) can go in a footnote as long as the body copy indicates "restrictions exist"?

The advisory says "If the manufacturer elects to include coverage codes within the APS, the codes must be accompanied by the corresponding coverage criteria (e.g. inclusion/exclusion criteria), definitions, and notes where applicable. These elements may be included in a footnote."

But I am unclear whether "these elements" (e.g., coverage criteria) can go in a footnote only if the manufacturer elects to use coverage codes, or in all cases?

Thanks so much!