Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
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Can you tie a #1 dispensed claim to an indication?
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Based on the PAAB guidance on market share claims (www.paab.ca/Retention_and_market_share_claims.pdf), it sounds like you must have directly observable data to tie a #1 dispensed claim to an indication (disease had to be entered into database). I just want to double check something:
Let's say your product is a ProteinX inhibitor and is only indicated in DiseaseA. When you pull all the IQVIA data for all the ProteinX inhibitors indicated in Canada for DiseaseA, you see that your product has >5% market share (but you do not have access to the disease for each prescription dispensed). In the above guidance, it says that if any of the competitors have multiple indications, you cannot tie the claim to the indication. This is where I'm confused, if your product has market share and is only indicated in DiseaseA, then it even if the competitors have multiple indications, if anything this would dilute their market share, right? It wouldn't increase it?
Could you please help me understand why this isn't allowed? (tying market share to indication when only one indication, in the absence of directly observable disease data)
Thank you!
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Based on the PAAB guidance on market share claims (www.paab.ca/Retention_and_market_share_claims.pdf), it sounds like you must have directly observable data to tie a #1 dispensed claim to an indication (disease had to be entered into database). I just want to double check something:
Let's say your product is a ProteinX inhibitor and is only indicated in DiseaseA. When you pull all the IQVIA data for all the ProteinX inhibitors indicated in Canada for DiseaseA, you see that your product has >5% market share (but you do not have access to the disease for each prescription dispensed). In the above guidance, it says that if any of the competitors have multiple indications, you cannot tie the claim to the indication. This is where I'm confused, if your product has market share and is only indicated in DiseaseA, then it even if the competitors have multiple indications, if anything this would dilute their market share, right? It wouldn't increase it?
Could you please help me understand why this isn't allowed? (tying market share to indication when only one indication, in the absence of directly observable disease data)
Thank you!
Per FAQ 2 of the PAAB guidance cited in your query, as there is no direct observable data, off-label use cannot be ruled out even with a single indication. There is insufficient data to truly account for the clinical use/indication for each compared product. Without such data, the comparisons could be potentially misleading and thus not acceptable.
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Per FAQ 2 of the PAAB guidance cited in your query, as there is no direct observable data, off-label use cannot be ruled out even with a single indication. There is insufficient data to truly account for the clinical use/indication for each compared product. Without such data, the comparisons could be potentially misleading and thus not acceptable.
@jennifer-carroll
Okay I understand now, so saying "#1 dispensed ProteinX inhibitor for DiseaseA" would be misleading if 90% of those dispensings were really for the off-label treatment of DiseaseB? Yep, that makes sense, thank you!
