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  3. Lives covered by private insurance message
PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

Lives covered by private insurance message

Scheduled Pinned Locked Moved PAAB Q&A
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  • K Offline
    K Offline
    karen.taylor
    wrote on last edited by
    #1

    Hello! A client has asked about whether a message that summarizes the percentage of Canadian lives covered by private insurance for a particular product (without mention of disease state or indication) meets the exemption criteria around formulary messages?

    Jennifer CarrollJ 1 Reply Last reply
    0
    • K karen.taylor

      Hello! A client has asked about whether a message that summarizes the percentage of Canadian lives covered by private insurance for a particular product (without mention of disease state or indication) meets the exemption criteria around formulary messages?

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hello @karen-taylor

      No. The exemption criteria states: Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages. Suggesting number of patients that could be covered for the product is a promotional claim and does not meet the exemption criteria 1.5Dii.

      R S 2 Replies Last reply
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      • R Offline
        R Offline
        rlevit1
        wrote on last edited by
        #3

        As "lives covered" data can evolve with time as new insurance companies are added, is the expectation to submit an updated tool to PAAB every time, or it can be approved with X% with a note that data will be updated without PAAB review?

        Jennifer CarrollJ 1 Reply Last reply
        0
        • Jennifer CarrollJ Jennifer Carroll

          Hello @karen-taylor

          No. The exemption criteria states: Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages. Suggesting number of patients that could be covered for the product is a promotional claim and does not meet the exemption criteria 1.5Dii.

          R Offline
          R Offline
          rlevit1
          wrote on last edited by
          #4
          This post is deleted!
          1 Reply Last reply
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          • R rlevit1

            As "lives covered" data can evolve with time as new insurance companies are added, is the expectation to submit an updated tool to PAAB every time, or it can be approved with X% with a note that data will be updated without PAAB review?

            Jennifer CarrollJ Offline
            Jennifer CarrollJ Offline
            Jennifer Carroll
            wrote on last edited by
            #5

            Hello @rlevit1

            In theory, it may be possible to update the total number within an APS when the claim is restricted to something like “Up to 40% of patients with private insurance are covered for Brand B” and the reference/data source remains the same as that evaluated during the initial review. Any additional changes (such as listing the providers, or a new data source), would require resubmission. If this is the intent, it should be disclosed during the initial review process so that the reviewer may adequately assess the need for future submissions and confirm any additional considerations.

            ** The above response should not assume that the claim “lives covered” has been approved.

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            • Jennifer CarrollJ Jennifer Carroll

              Hello @karen-taylor

              No. The exemption criteria states: Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages. Suggesting number of patients that could be covered for the product is a promotional claim and does not meet the exemption criteria 1.5Dii.

              S Offline
              S Offline
              Supraja
              wrote on last edited by
              #6

              @jennifer-carroll Hello,

              I have a follow-up question to this post, and regarding the exemption criteria 1.5Dii.

              Would a message that simply states "Covered by private insurance" be considered exempt? Since it doesn't mention any statistics or number of patients, would it be viewed as similar to "now on provincial formulary”?

              Appreciate your guidance!

              Jennifer CarrollJ 1 Reply Last reply
              0
              • S Supraja

                @jennifer-carroll Hello,

                I have a follow-up question to this post, and regarding the exemption criteria 1.5Dii.

                Would a message that simply states "Covered by private insurance" be considered exempt? Since it doesn't mention any statistics or number of patients, would it be viewed as similar to "now on provincial formulary”?

                Appreciate your guidance!

                Jennifer CarrollJ Offline
                Jennifer CarrollJ Offline
                Jennifer Carroll
                wrote on last edited by
                #7

                Good Morning @supraja

                The exemption you're referring to specifically applies to provincial formulary coverage and is based on the understanding that distribution is limited to provinces where the statement is accurate. This precision is intentional. Although “Covered by private insurance” might seem like a similar claim, it is actually unclear and potentially misleading. It implies that all patients with private insurance will be covered, which may not be
                the case, as the product is likely only covered under a subset of private plans. A claim such as “Covered by most private insurance plans” might be more accurate, but including such a qualifier would disqualify the APS from exemption and trigger disclosure requirements (e.g., indication, fair balance).

                S 1 Reply Last reply
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                • Jennifer CarrollJ Jennifer Carroll

                  Good Morning @supraja

                  The exemption you're referring to specifically applies to provincial formulary coverage and is based on the understanding that distribution is limited to provinces where the statement is accurate. This precision is intentional. Although “Covered by private insurance” might seem like a similar claim, it is actually unclear and potentially misleading. It implies that all patients with private insurance will be covered, which may not be
                  the case, as the product is likely only covered under a subset of private plans. A claim such as “Covered by most private insurance plans” might be more accurate, but including such a qualifier would disqualify the APS from exemption and trigger disclosure requirements (e.g., indication, fair balance).

                  S Offline
                  S Offline
                  Supraja
                  wrote on last edited by
                  #8

                  @jennifer-carroll that makes sense, thank you for clarifying!

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