Can you tie a #1 dispensed claim to an indication?
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)
Jennifer Carroll last edited by
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.
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!