663 - Can baseline patient demographics (not outcomes) captured by Patient Support Program enrollment be used in HCP-directed advertising, in a promotional or claim-neutral manner?
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I assume you are asking whether you can support a statement like X% of patients with condition Y have characteristic Z. Patient support program enrollment data would not meet the standard level requirements for epidemiological statements about the disease (e.g. demographics). A published and peer-reviewed epidemiological study which is relevant to the Canadian market could be considered as could an authoritative source such as Canadian guidelines.
Another important consideration, in addition to the evidentiary issue, is whether discussion of that particular sub-population would be acceptable in the branded piece (e.g. is the subpopulation discussed in the TMA?) -
I assume you are asking whether you can support a statement like X% of patients with condition Y have characteristic Z. Patient support program enrollment data would not meet the standard level requirements for epidemiological statements about the disease (e.g. demographics). A published and peer-reviewed epidemiological study which is relevant to the Canadian market could be considered as could an authoritative source such as Canadian guidelines.
Another important consideration, in addition to the evidentiary issue, is whether discussion of that particular sub-population would be acceptable in the branded piece (e.g. is the subpopulation discussed in the TMA?) -
@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?
Hi @constance
General enrollment based on geography may be considered when presented in a clear manner and with adequate disclosure of the pertinent PSP program information. For the highlighting of patient characteristics such as gender and age, acceptability is dependent on the balance of the APS content and supporting data as there will be subgroup emphasis considerations with such highlighting.
