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Jennifer Carroll

As a general principle, the clinical decision to prescribe or switch should be made based on clinical considerations. Patient preference can be a part of a patient profile but should not be positioned as the reason to prescribe or switch. Patient preference can be presented as a consideration, without drawing conclusions about clinical actions.
With respect to the specific case presented in the question, the copy in the guidelines and the APS would have to be assessed at the time of submission. We’d caution that “broadly defined” may be problematic and that drawing inference around patient choice such as “difficulty remembering to take pills and therefore might prefer injections” would require statistically significant evidence from a published high quality source.

adelaidebaker

Hi PAAB,

I’m looking for clarification regarding whether patient preference can be cited in a patient profile as an acceptable reason for switching to a different treatment.

Specifically, if Canadian clinical guidelines indicate that patient preference is a legitimate consideration when selecting or switching medications, would it be acceptable to reference, for example, that a patient dislikes oral medications or has difficulty remembering to take pills—as a rationale for considering an injectable treatment instead?

I understand that we must avoid any disparaging remarks about other products or dosage forms. However, if the rationale is grounded in patient preference and is consistent with guideline-based reasoning (even if “preference” is somewhat broadly defined), would this type of messaging be considered acceptable?

Looking forward to your guidance on this.

Jennifer Carroll

Good Afternoon @Manufacturer and @Agency

It's crazy to say but we're now just past halfway through 2025!

The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q2. See the Tag report here and the CEI report here.

The Forum Quarterly Review for Q2 has also been posted here.

If there's more you'd like to know in Q3, let us know in the comments below. Have a wonderful rest of the summer.

Thank you
PAAB

Jennifer Carroll

Hi @support

A strictly informational statement about stock such as “Product X 5mg dose now back in stock” could be considered exempt.

The inclusion of the indication statement renders it no longer exempt.
The inclusion of a product photo MAY render it no longer exempt. This piece should likely be submitted for an exempt opinion to assess if the product photo can be used while meeting exempt criteria.

support

Hi Jennifer,

Thank you for your response!

If we were to include a message about a specific dose of the product that is now back in stock, would this piece still be exempt?
Additionally, would the inclusion of the indication statement or product photo make this no longer exempt?

Looking forward to hearing from you.

Lily

Jennifer Carroll

Good morning, @Manufacturer @Agency

PAAB will be performing an upgrade to the eFiles system tonight, July 29th. We will be shutting the eFiles system down from 5pm-midnight to perform the upgrade. Please note that users will not have access to eFiles during this time.

We’re sorry for any inconvenience that this causes.

Thank you
PAAB

Jennifer Carroll

Hey @support

A simple availability message such as “Product X is now back in stock” would be considered exempt. To remain exempt it should be limited to an informational message (not linked to therapeutic or promotional messages) about stock. (s1.5D)

support

Hi PAAB!

Would a message like "X product is now back in stock!" be subjected to PAAB review?

If it is not subjected to PAAB review, what are the conditions that it has to meet?

Thanks in advance!

Lily

Jennifer Carroll

Hey @dmauri
Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada.

When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).

Jennifer Carroll

Hey @JDilly11

Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.

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