hi Paab!
I would like to develop an APS to highlight all of the Rx products we have in our portfolio (all with the same indication). Provided I can find a compared prices must come from a single independent source (as described in question 438), would I be able to present the price as a unit cost? For example, the price of injectable pen X is $450 for 450 units, i.e. $1/unit.
@jennifer-carroll does this also apply to a new indication of an already approved product? In other words, "New indication coming soon"
@Jennifer-Carroll just following up on this.
Thank you, PAAB, for the informative town hall on December 19. After reviewing the communique, I have a few follow-up questions:
Is Phase 1 complete, or are there additional steps before it goes live? If there are additional steps, what are they, and what is the expected go-live date?
What level of understanding do manufacturers have regarding this initiative? As their agencies, is it our responsibility to bring them up to speed, or is that the purpose of the debrief meeting?
Could you please clarify who should attend the debrief meeting you are suggesting? Should both agencies and manufacturers be present?
Regards,
Constance
Hello PAAB! In cases where provincial formulary coverage of a product is restricted (e.g., special authorization) do all of the coverage criteria, definitions, and notes have to be included with the APS or can you simply link to them (via a "See Coverage Criteria" button) on the corresponding page on the provincial formulary web site. As well, if a criterion is one where we have no data in our PM, do we have to disclaim the criteria in some way? (i.e. "Product X has not been studied for this criterion"?
@jennifer-carroll if a group of products could potentially be presented in a single co-promotional tool, as you mention above, can you please elaborate on what you mean by: "with the information relating to each individual brand being separate and distinct"? And to be clear, I am asking about how information from the TMA gets presented, not the ongoing trials.
For instance, do you mean that info from the TMA (i.e. efficacy, safety, dosing, MOA, etc.) relating to each individual product/indication has to be presented as a separate and distinct module within the co-promotional tool?
And are there any considerations you can share when it comes to presenting a group of products/indications within a single APS?
@jennifer-carroll would demographic information like the number of patients enrolled in a PSP by province or by gender or by age be permitted in HCP directed advertising?
@jennifer-carroll Assuming a product has several ongoing trials as per the PAAB definition of "ongoing", can the APS include study design, inclusion/exclusion criteria, and patient characteristics? I don't believe this part of the question was addressed. More specifically, within a branded APS (like a detail ad) can tab be added, away from the clinical data, with a table describing all ongoing trials.
@jennifer-carroll if there is an opportunity for us to contribute to this (send in our examples), please let me know.
@jennifer-carroll assuming the patient profile meets all these conditions, does it have to be a real photo, or would an AI generated image based on the before and after clinical results for patient be acceptable?
@jennifer-carroll Checking in on this again. Any developments?
@jennifer-carroll this is excellent news. I read the guidance document today.
@jennifer-carroll has there been any further developments on the Creative Imagery Committee? I searched the PAAB web site but did not find anything further on this topic.
Good afternoon @jennifer-carroll! Point well taken about the circumstances under which a CSR can be used as evidence, but what about the second part of this question? If we able to submit a partial version of the report, can you confirm what parameters should be considered? Thanks!
