Can you show dispensing data across different brands?
I was wondering if you can show the dispensing data for different brands in an APS? For example, could you graph IQVIA data over the last 12 months (either # of dispensings, or % of market share) of your brand vs. competitors? And, if this is allowed, some follow up questions:
-Are there rules about showing data for originator brand biologics vs. biosimilars? For example, let's say your brand has no biosimilars, but a competitor has 5 different biosimilars, do you have to pool the competitor biologic and it's biosimilars together into one line on the graph, or can it be split out into 6 lines for each biosimilar? Or is it our choice (we can use brand name or drug molecule name to label the graph, whichever makes more sense)?
-Are you allowed to make any claims from this data? I would assume you could make a "#1 dispensed" claim since we use this data to support these claims? I understand the graphs would have to be updated each year with the the most recent data. Could you make comparative claims?
-In the absence of any claims, how inclusive do you have to be? For example, if you are comparing your brand (a protein-X inhibitor) to other protein-X inhibitors, some protein-Y inhibitors, a few protein-Z inhibitors, do you have to show the data for ALL protein-X, -Y, and -Z inhibitors authorized in Canada?
If there's any other red flags that pop into your head with this kind of thing, I would be very grateful to hear them! Otherwise, thank you so much for your time with my long question
Jennifer Carroll last edited by
It is hard to say for certain without seeing the presentation, but from our interpretation of your description of the presentation, it would not be permissible. Market share claims should meet the requirements outlined in the Guidance Documents for Market Share Claims in Advertising. Additionally, the FAQ 1 and 2 at the base of Retention and Market Share Claims will likely be highly relevant when discussing biologics and biosimilars and push the answer towards “not permissible”. Splitting innovators from the successors would not accurately convey the market distribution of the active ingredient, and combining products is not quite accurate. Both scenarios would be misleading and therefore unacceptable.
The only non-misleading presentation would be “#1 dispensed…” if the requirements for this type of claim were met (e.g. both “a minimum lead of at least 5% (absolute) over all other products in the same category during the most recent 12-month period AND during each of the last 6 consecutive months” set within a logical market definition).
If you remain uncertain, we suggest submitting for an opinion.
@jennifer-carroll Thanks Jen! I hadn't seen that "Supplementary Guidelines for Market Share Claims" before and that is really helpful!