182 - I am hoping that you can help provide us some guidance with respect to the use of "Now on Formulary" stickers. It is our understanding that such stickers are exempt from PAAB review as long as they are not linked to a therapeutic message in any way as per Section 6.6 d(ii) of the PAAB code. In the past when we have submitted such stickers to the PAAB, we have been asked to provide examples of where a sticker will be placed on previously approved APS. This occasionally becomes a problem when trying to assess viable placement options. For us, the guiding principles have been the following:
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Modification of existing formulary claims and/or addition of formulary claims to previously approved APS require PAAB review. These changes do not qualify as “FYIs”. Note that the reference requirements on page 1 of the PAAB Advisory document “Provincial Formulary Coverage Statements” apply. Additionally, PAAB requires the previous eFile number(s) and updated layout(s) for assessment. We acknowledge that manufacturers may need to update multiple PAAB approved pieces in order to inform healthcare professionals about formulary changes. Multiple PAAB approved pieces may be included within a single submission provided all of the following factors are met:
- The APS modifications are submitted on the same day.
- Only files within the PAAB approval period can be grouped together in this manner. The modified APS will retain the same acceptance period as the previously approved APS (i.e. a new acceptance number will not be issued).
- There are no changes to the APS other than the formulary claim.
- The formulary message does not include coverage criteria or codes.
Changes relating to coverage codes or criteria must be submitted as separate files.
