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    • T

      Financial Assistance
      • tmcd

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      Jennifer Carroll

      Good afternoon @tmcd

      Yes, assuming that you are speaking to the average out-of-pocket cost that the sponsor’s Patient Support Program will cover for eligible, enrolled patients. Note that it should be specific to the sponsor’s product and that a range (min-max) would be required to also be included (in the attestation and on the face of the piece), so as to be clear and complete

    • G

      Using RWE as support for a comparison claim
      • gbrl88

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      Jennifer Carroll

      Good Morning @gbrl88

      Apologies for not seeing this sooner. Thank you for bringing this document to our attention. This informational piece was put out while we were discussing proposed changes to the use of RWE. However, the proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising. As such, we will be taking the document referenced above, down.

      As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.

    • T

      Video embedded in an IVA APS
      • tmcd

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      Jennifer Carroll

      Hello @tmcd
      If the video is to always be part of the IVA and never shown outside of the IVA, it is fair to assume that the fair balance and logos do not have to be incorporated into the video itself, if it is sufficiently captured in the IVA (i.e. minimum middle level fair balance). When submitting, the IVA should be included in the submission, with clear instructions on the incorporation into the IVA (i.e. placement, access, any additional functionality accorded to the video or IVA to access the video).

    • L

      COVID-19 information on patient website
      • llmktg

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      Jennifer Carroll

      Hey @llmktg

      As a general guidance, advertising material must be consistent with the TMA and be supported by quality references. No copy, content or linkages should suggest that the product somehow helps to manage/prevent/detect COVID-19 infection that extends beyond the TMA.

      With that in mind, any specifics about the disease (COVID) should be directed to the homepage of groups considered to be authoritative sources, such as the WHO and Public Health Agencies for disease information. As the product is not indicated for COVID and it is not likely that there is COVID specific messaging in the TMA, it may be misleading to present this information on the branded website. It could house links to acceptable resources, and house material on practical information, e.g. virtual appts, mask wearing etc. clearly separate from any branding messages or content. The sponsor should ensure separation is done in a distinct manner so as not to suggest that the sponsors brand addresses the condition.

      When we start to get into how comorbidities interact with the condition and it’s treatment or the treatment the patient is on, the evidence requirements are subject to statistically significant data from high quality studies per our usual review.

    • S

      Superiority Claim
      • Sil

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      Jennifer Carroll

      Hey @Sil

      Evidence not presented in the TMA can be considered in pieces when it is consistent with the TMA and supported by statistically significant, high quality data of predefined study endpoints from a published and peer-reviewed randomized control trial (s.5.9). You have correctly identified some key features we look for (i.e. same indication, consistency with outcome type) along with other things such as comparable dosage strengths or blinding. A key document on the PAAB website which can further assist you in assessing the potential acceptability of the study and claims you wish to make the Marketing benefit claims: what are they and what level of support do they require document. You may also want to check out Subjective versus Objective Endpoints and Guidance on Non-inferiority Trials which speak to consistency with the TMA.

    • U

      Dose adjustments for products used in combination
      • Username

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      U

      Thank you for your quick response!

    • C

      Unadjusted p-values
      statistics multiplicity unadjusted • • COREkarentaylor

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      C

      Thanks @Jennifer-Carroll!

    • Jennifer Carroll

      766 - Can you confirm if a CSR (Clinical Summary Report) is an acceptable document to support a data presentation from a published clinical trial. For example, the published clinical report presents pooled data results but the CSR captures this same endpoint by individual pivotal studies which garnered NOC for the drug. Additionally, can client share a portion of the document rather than the entire document given these reports are typically 2000+ pages. If it is possible to submit a partial version of the report, please confirm what parameters should be considered. thank you.
      • Jennifer Carroll

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    • Jennifer Carroll

      762 - I am interested in the safety data for one of the products. Can i use data from a pooled analysis of 10 clinical trials (same indication and product) in our marketing materials. It contains data from pivot clinical trials as well. Can it be considered as a meta-analysis?
      • Jennifer Carroll

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    • D

      Patient Satisfaction Claims
      • Danielle

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      Jennifer Carroll

      Hello @Danielle

      PAAB Q&A 387 and 338 cover patient satisfaction, surveys, perception of efficacy, safety, ease of use and preference claims. Please provide us with an example of a “non-subjective satisfaction measure” as satisfaction is inherently subjective (measures an individuals perceived fulfillment of expectations).

      The PAAB resource Marketing benefit claims: What are they and what level of support do they require? provides additional guidance.

    • Jennifer Carroll

      721 - Can a patient survey be used to support claims of ease of use? Would it make a difference if the prescription product were administered through a Class-II medical device?
      • Jennifer Carroll

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    • Jennifer Carroll

      751 - Similar to question #711, if we have unpublished patient survey data that was independently collected from a patient association, could it be used in an unbranded tool? If yes, what exactly would be required as the source document
      • Jennifer Carroll

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    • Jennifer Carroll

      748 - Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?
      • Jennifer Carroll

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    • L

      COVID-19 Question Responses
      • lilymcneil

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      Jennifer Carroll

      @lilymcneil

      These questions may be acceptable if the content, context, and link aligns with the general guidance provided in our prior response. Of course, copy specific guidance would be provided as part of the review process. Questions and responses need to be assessed in the context of the entire piece and with assessment of the references.

    • A

      Generic product launch announcement: can we mention the original brand name?
      • akar

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      Jennifer Carroll

      @akar Great question.

      Note that any of the proposed content would require review under the PAAB code. This is occasionally a point of confusion in the generic space.

      If the generic product’s TMA refers to the innovator brand as the reference product, the generic manufacturer may convey this fact in the APS. For example, “… generic version of Drug X [the reference product]”.

      In the unlikely event that the reference product is no longer authorized for sale, this should be conveyed through a cross-reference to the claim above. However, a manufacturer should only discuss the availability status of its own products. For example, it would be unacceptable to comment on a competitor’s drug shortage issues.

      Any messages relating to switching will require support from the TMA or standard setting organizations.

    • Jennifer Carroll

      752 - Hi PAAB, I was reviewing my brands promotional pieces that will need to either be updated or be sent for rePAAB over the next few months. Since some of the pieces were approved, we have had a product monograph update. However, for certain pieces it does not change the Terms of Market Authorization and in some cases the copy in the piece wouldn't need to be changed. The only part of the piece which would need to be changed is the date of the Product Monograph (e.g. brochure) within the references. Since we have significant print inventory, is it permissible to have these submitted as a rePAAB to be valid for the next year until the next update or rePAAB without updating the date of the product monograph within the piece? Please advise. Many thanks.
      • Jennifer Carroll

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    • NatBourre

      Real world evidence focused on patient compliance
      • NatBourre

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      Jennifer Carroll

      We’d need to assess the methodology through which the data was collected and analyzed through the third party research company. Ultimately, it's possible but unlikely since adherence is quite difficult to measure. It is important to distinguish between adherence and retention. Often when folks say the former, they are actually referring to the latter.

      PAAB interprets compliance/adherence as the extent to which patients administer the medication as instructed by the HCP. This is in contrast to persistence / retention which PAAB interprets simply as continued dispensing of the prescribed medication. It is inherently difficult to reliably measure patient adherence / compliance. We have yet to receive acceptable third party data that supports comparative adherence claims.

      However, PAAB regularly considers persistence / retention data from recognized or validated claims-based market data providers. The data may be comparative if it is less than 6 months old. Inferences (like “Drug X demonstrated higher retention rate vs drug Y”) may be made if supported by statistical significance.

    • Jennifer Carroll

      745 - We have an 8 page print leave-behind detail aid that includes full dosing information. We are thinking of redoing this tool with a half page sized tear off flap that has key reminder information on the dosing. Does this flap have to contain all of the dosing information, or can it just contain e.g., the steps and an example calculation. Thanks.
      • Jennifer Carroll

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    • Jennifer Carroll

      743 - Hi PAAB, I was wondering if expert guidelines for treatment option algorithms (first line, second line) are allowed to be included in branded pieces directed at HCPs. The goal would not be to compare treatments but to see under which situations / for what patients a therapy would be preferred. (Patient profile?) Thanks for your help!
      • Jennifer Carroll

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    • Jennifer Carroll

      735 - Hello, If we want to do a video about the Mode of action of a drug, apart from the PM, what other references can we use?
      • Jennifer Carroll

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