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  3. Product costs claims
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.

Product costs claims

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  • D Offline
    D Offline
    dlew
    wrote last edited by
    #1

    Is it possible to include claims around "no additional product cost for patients" in HCP/ patient materials?
    ex: "Drug X reimbursed by private or public plans - at zero additional costs for most patients"

    Is there a specific type of support that would be needed to support a claim of this nature?

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

      Hey @dlew
      Coverage claims may be considered in HCP APS. Patient information should not contain promotional claims but formulary information may be considered. Please see our patient information guidance. HCP claims about “cost” should be factual and complete. A claim of “at zero additional cost for most patients” would be a hanging comparison and would need to clearly state versus what and be supportable across all public and private payers. Remember that formulary bodies have requested that messaging around coverage be limited to statements of coverage and not promotional messaging around “savings”. Additionally, messaging around cost should be clear about what costs (e.g. drug acquisition costs, mark-up, dispensing fee, etc.).

      Private coverage claims can be supported by independent third party data from an established company who assess’ market access.

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