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Hi @Danielle Section 1.1.4 Endpoints/ Outcomes of the Guidance on Real-World Evidence states “Endpoints/Outcomes must be “consistent with” (though not necessarily “the same as”) those in the TMA. Regardless of whether the evidentiary basis for the presentation is RWE/RWD or an RCT, endpoints are not generally limited to those explicitly included within the TMA. Though the approach for RWE/RWD mirrors that for RCTs in this respect, the following examples are intended to clarify questions received during the consultation process.” You can review the examples in the linked document. Assessment of “consistent with” is made in the context of the combination of the endpoint, TMA and the therapeutic area. The submitter should provide authoritative support within the submission, to support that the endpoint is consistent or similar to those in the TMA and that it is a recognized endpoint within the therapeutic area.

Hey @mef Thank you for flagging this. We've discussed the matter with the review team to ensure alignment and are updating both internal and external guidance documents for clarity. In most cases, study design footnotes may appear outside the box.

Good Morning @dmauri This is a specific review question. Please submit the guidelines and proposed product claims. This can be done in a full submission or an opinion if you’d like further clarification prior to building out tools.

Hey @Username “Schedule 2” is a bit broad. There are many factors and combinations to consider. Could you provide the product or therapeutic class, or Federal drug schedule (see link) to help narrow down the response. Alternatively, if you’re not comfortable sharing in a public space, you can email review@paab.

Hello @Jennifer-Thomson It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval.

Hey @ALee The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included.

Thank you!

Hey @ALee Not at this time based on PAAB code section 3.1.2 but something we can keep on a list to explore in the future.

Good morning, @Username Comparative data remains subject to the guidance for evidentiary basis to support comparative claims. As noted above, consideration may apply when the study can be demonstrated to be the basis for approval of the biosimilar. A study that is NOT part of the basis for approval and completed post approval, should meet the standards for high quality evidence (i.e. pre-defined statistically significance endpoints).

Good morning, @copycallosum In theory, this sounds like an acceptable activity.

Hi @Jennifer-Carroll. In your response to question 762, you mention that one of the circumstances in which PAAB will accept pooled analysis as stand-alone evidence for a therapeutic claim is when it is preplanned. However, in this scenario, you’ve indicated that data from a preplanned open-label pooled LTE is not acceptable. Could you please clarify the distinction and explain why this particular case does not meet the criteria?

Hi @Jennifer-Carroll Thank you!

Hey @mimi77 Yes. It would be considered discussion of drug therapy or content relating to drug therapy.

Hello @mimi77 During the review, you’d want to make the reviewer aware of the intended link. They will advise if it can be linked based on the content in the PAAB-exempt piece and the unbranded disease-state piece undergoing review.

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.

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).

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.