Lives covered by private insurance message
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Hello! A client has asked about whether a message that summarizes the percentage of Canadian lives covered by private insurance for a particular product (without mention of disease state or indication) meets the exemption criteria around formulary messages?
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Hello @karen-taylor
No. The exemption criteria states: Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages. Suggesting number of patients that could be covered for the product is a promotional claim and does not meet the exemption criteria 1.5Dii.
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As "lives covered" data can evolve with time as new insurance companies are added, is the expectation to submit an updated tool to PAAB every time, or it can be approved with X% with a note that data will be updated without PAAB review?
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Hello @rlevit1
In theory, it may be possible to update the total number within an APS when the claim is restricted to something like “Up to 40% of patients with private insurance are covered for Brand B” and the reference/data source remains the same as that evaluated during the initial review. Any additional changes (such as listing the providers, or a new data source), would require resubmission. If this is the intent, it should be disclosed during the initial review process so that the reviewer may adequately assess the need for future submissions and confirm any additional considerations.
** The above response should not assume that the claim “lives covered” has been approved.
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@jennifer-carroll Hello,
I have a follow-up question to this post, and regarding the exemption criteria 1.5Dii.
Would a message that simply states "Covered by private insurance" be considered exempt? Since it doesn't mention any statistics or number of patients, would it be viewed as similar to "now on provincial formulary”?
Appreciate your guidance!
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Good Morning @supraja
The exemption you're referring to specifically applies to provincial formulary coverage and is based on the understanding that distribution is limited to provinces where the statement is accurate. This precision is intentional. Although “Covered by private insurance” might seem like a similar claim, it is actually unclear and potentially misleading. It implies that all patients with private insurance will be covered, which may not be
the case, as the product is likely only covered under a subset of private plans. A claim such as “Covered by most private insurance plans” might be more accurate, but including such a qualifier would disqualify the APS from exemption and trigger disclosure requirements (e.g., indication, fair balance). -
@jennifer-carroll that makes sense, thank you for clarifying!
