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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.

Reimbursement Sticker

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  • K Offline
    K Offline
    Kiki
    wrote on last edited by
    #1

    Our brand would like to create a sticker with an LU code listed and they are willing to put the code criteria also on the sticker. The sticker will then be placed on various branded, PAAB approved leave behinds. So a) can this be done? And b) if the criteria is broader than the indication, is that an issue?

    palanskiP 1 Reply Last reply
    1
    • K Kiki

      Our brand would like to create a sticker with an LU code listed and they are willing to put the code criteria also on the sticker. The sticker will then be placed on various branded, PAAB approved leave behinds. So a) can this be done? And b) if the criteria is broader than the indication, is that an issue?

      palanskiP Offline
      palanskiP Offline
      palanski
      wrote on last edited by
      #2

      @kiki

      I'm sure that @Jennifer-Carroll will provide a more complete/corrected answer, but in the spirit of getting the conversation going I thought I'd provide a few initial resources/thoughts:

      • Our brand would like to create a sticker with an LU code listed and they are willing to put the code criteria also on the sticker.
        • Just a note that if you're opting to include the LU code, you will also have to include the criteria (i.e., that's not optional); see Provincial Formulary Coverage PAAB Guidance.
      • The sticker will then be placed on various branded, PAAB approved leave behinds. So a) can this be done?
        • Yes, but sticker placement will have to be assessed for all tools; see PAAB Q&A #516.
      • And b) if the criteria is broader than the indication, is that an issue?
        • This will be an issue in the scenario you described, given the criteria would be considered off label. See this post.
      Yin ManY 1 Reply Last reply
      0
      • palanskiP palanski

        @kiki

        I'm sure that @Jennifer-Carroll will provide a more complete/corrected answer, but in the spirit of getting the conversation going I thought I'd provide a few initial resources/thoughts:

        • Our brand would like to create a sticker with an LU code listed and they are willing to put the code criteria also on the sticker.
          • Just a note that if you're opting to include the LU code, you will also have to include the criteria (i.e., that's not optional); see Provincial Formulary Coverage PAAB Guidance.
        • The sticker will then be placed on various branded, PAAB approved leave behinds. So a) can this be done?
          • Yes, but sticker placement will have to be assessed for all tools; see PAAB Q&A #516.
        • And b) if the criteria is broader than the indication, is that an issue?
          • This will be an issue in the scenario you described, given the criteria would be considered off label. See this post.
        Yin ManY Offline
        Yin ManY Offline
        Yin Man
        wrote on last edited by Jennifer Carroll
        #3

        @Kiki

        Thanks @palanski for the thorough answer. Your response is accurate and complete.

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