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  4. Advisory regarding use of RAMQ in APS (April 2016)
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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.

Advisory regarding use of RAMQ in APS (April 2016)

Scheduled Pinned Locked Moved Guidance on Code Application
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  • D Offline
    D Offline
    devadmin
    wrote on last edited by Jennifer Carroll
    #1

    Enter your comments on this document here:

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    • J Offline
      J Offline
      jen_kent
      wrote on last edited by
      #2

      Hi @Jennifer-Carroll,

      Wondering if there had been any consideration to loop back with RAMQ on this guidance?
      More specifically around "off-label" criteria, as I'm sure there are quite a few brands impacted, and the inability to even mention RAMQ for a tool.

      Based on our reading of the document, even removal of discrete off-label criteria and maintenance of on-label criteria, wouldn't abide by their requests if all indications are presented.

      Given these requests were provided directly to PAAB, we were wondering if there would be an opportunity to inquire with RAMQ whether there is anything that can be done? For example, is there something that could be said to just direct people to the website to find out more without implying coverage/criteria? Could a general statement of "For information on availability of formulary coverage in Quebec, please visit https://www.ramq.gouv.qc.ca/en/about-us/list-medications" (or something similar to add mention of potential criteria) be acceptable by RAMQ and PAAB?

      We're open to additional thoughts around potential alternatives or next steps!

      Thanks!

      Jennifer CarrollJ 1 Reply Last reply
      0
      • J jen_kent

        Hi @Jennifer-Carroll,

        Wondering if there had been any consideration to loop back with RAMQ on this guidance?
        More specifically around "off-label" criteria, as I'm sure there are quite a few brands impacted, and the inability to even mention RAMQ for a tool.

        Based on our reading of the document, even removal of discrete off-label criteria and maintenance of on-label criteria, wouldn't abide by their requests if all indications are presented.

        Given these requests were provided directly to PAAB, we were wondering if there would be an opportunity to inquire with RAMQ whether there is anything that can be done? For example, is there something that could be said to just direct people to the website to find out more without implying coverage/criteria? Could a general statement of "For information on availability of formulary coverage in Quebec, please visit https://www.ramq.gouv.qc.ca/en/about-us/list-medications" (or something similar to add mention of potential criteria) be acceptable by RAMQ and PAAB?

        We're open to additional thoughts around potential alternatives or next steps!

        Thanks!

        Jennifer CarrollJ Offline
        Jennifer CarrollJ Offline
        Jennifer Carroll
        wrote on last edited by
        #3

        Hello @jen_antibody

        Great question. To clarify, the request from RAMQ is to ensure that the coverage criteria are always clear and complete, so as not to suggest the indication is the coverage criteria (except where this is indeed the case). The document states: Coverage claims must be accompanied by reimbursement criteria (if applicable to the indications promoted in the piece). This means, that not all criteria are required in the piece. The discrete criteria which are not for the indicated population (i.e. off-label criteria), CAN be removed from the coverage criteria. All formulary claims, across Canada, for discrete off-label use would need to be removed, this is not exclusive to RAMQ. If there are additional indications for the product, which RAMQ does not cover, the formulary presentation/claim should be clearly limited to the indications with RAMQ coverage.

        A statement similar to “For information on availability of formulary coverage in Quebec, please visit link” would still allude to RAMQ and be subject to the RAMQ request. However, to reiterate, the RAMQ request does not preclude the removal of off-label discrete coverage.

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