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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.

JDilly11

Hello,

The Product Monograph for a drug I work on is being updated. Specifically, there is adverse event information being added from a Dose Regimen study (which doesn't have a placebo arm). This data will be presented separately from the adverse event information from the placebo-controlled studies. My question is: what implications will this have for safety claims in promotional pieces? If we were to make a claim of "demonstrated safety profile", would we necessarily need to include the most common AEs from BOTH the placebo-controlled and Dose Regimen studies?

dmauri

Hello! We have come across multiple retrospective cohort studies that could potentially be used in APS, thanks to PAAB's Guidance on RWE. One issue that has come up for a couple of these studies is the lack of dosing information, which is required to fulfill 1.1.3 of the RWE Guidance. We believe that it is common for specific dosing information to be omitted from these studies, but think that it is fair to assume that a large majority of the patients would be dosed based on regional labels (e.g., SmPC, US PI). For such studies where dosing information is not available, can we simply cite the regional label?

Another consideration for a couple of these studies is the use of a "SoC" comparator pool, in which of some of the SoC treatments lacka Health Canada-approved indication that aligns with the study. Would this contravene 1.7 of the RWE guidance?

Thank you for your help!

Jennifer Carroll

Hey @mimi77
While we don’t provide reviews of the Forum, in general terms the claim should reflect the nature of the update. From our understanding of the description, this would be authorization in a new population (pediatrics) and not a net new indication. As such, claims should reflect “Now authorized for use in pediatric patients for x” or something similar.

mimi77

We are creating an HCP-directed marketing tool with the primary purpose of announcing a new pediatric indication for an existing product. This new indication is currently under review by Health Canada and the APS we are developing will be submitted to PAAB for review following NoC.

We would like clarification on the following:
If the Product Monograph lists this pediatric use under the "Indications" section, but the wording in that section is similar to “Drug X is now authorized for use in pediatric patients…” (rather than the typical wording of “Drug X is indicated for use in pediatric patients…”), would PAAB consider it acceptable for us to refer to this as a "new indication" in our HCP marketing tool? If not, would it be acceptable to refer to this as a "new authorized use"?

Thank you in advance for your guidance.

Jennifer Carroll

Hello @msargeant

Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.

Jennifer Carroll

Hey @HollyMed

Yes, per the copy "In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice". Note that there may be instances where we ask for more information about US guidelines. This is extremely rare and the rationale is disclosed during the review process. If you find yourself in this rare instance, please reach out to the reviewer for clarification.

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