Formulary message - exemption confirmation
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Our client has asked for confirmation as to whether a statement of “Another indication for Product X is now on formulary in province X" (not linked in any way to additional product messages and/or any mention of therapeutic area) meets the conditions of exemption for formulary announcement messages.
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The message “Another indication for Product X” is an unclear claim of product merit and an embellishment which extends beyond Section 1.5Dii of the PAAB Code “(“Materials Not Subject to Preclearance”). It accords significance to the formulary body listing the product for multiple indications. Formulary bodies have requested that coverage not be promoted in a manner that suggests endorsements for the product. As such, this message is not exempt and is not acceptable.
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@jennifer-carroll It is a fact that provincial formularies will often expand the funding criteria for listed products during a product's lifecycle. Can you suggest language that can be used to communicate this fact in a way that does not, in your words, amount to an "unclear claim of product merit and an embellishment". Note that AskPAAB Question 71 indicates that companies may inform of a changes in formulary status.
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In general, companies can provide communication regarding formulary changes as an informational “Update”/”Change”. PAAB can provide review for the overall message/context.
E.g., “The formulary status for Drug XYZ has been updated” followed by the updated criteria.
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@jennifer-carroll Thanks! So, just to be clear, would the message "The formulary status for Drug XYZ has been updated" (not linked to product/therapeutic area messages) by exempt from PAAB review under s.1.5?
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“The formulary status for Drug XYA has been updated” may potentially be exempt depending on the context in which it is presented. Our PAAB opinion service is available for exempt opinions.
