Identifying revisions to coverage criteria, indications, or fair balance in an APS
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Is it acceptable to visually identify revisions to coverage criteria (e.g., removed criteria bullets, revised duration of approval numbers, etc.) with elements such as strikethroughs, arrows, highlights, bolding, etc.? Could such revisions also be called out in text? (e.g., "there is no longer a requirement for previous systemic treatment").
Presenting updated coverage criteria without calling out the specific changes from the previous criteria could leave our audience confused as to what has changed.
Similarly, could similar visual elements or text callouts be used to identify changes to a product's indications or warnings?
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Hello @dmauri
In general, there is an ability to identify the changes in a neutral manner that does not suggest significance or embellish the change in any way. Occasions may arise where it is not acceptable to do this such as when the change highlights an off-label use or criteria that would not meet the requirements of the Code or in the Advisory – Provincial Formulary Coverage Statements
For indications and warnings, you should note however, that content which cannot be included in advertising due to F&DA s9.1, cannot be salvaged merely by placing a strikethrough over it. For example, inappropriate uses of annotations that come to mind include using strikethrough annotations to extend the duration of time that no longer approved uses/populations are included in advertising, or using strikethrough annotations to suggest that a risk is now completely null. Additionally, similar to formulary changes, copy should not be added which would embellish the significance of the change.
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@jennifer-carroll Thank you for clarifying!
