PAAB practice has been to accept communications from formulary bodies to the manufacturer which confirm listing and criteria in the absence of published coverage criteria. In the absence of these letters, we have accepted an attestation from the sponsor that confirms the EAP listing and that the government/ministry has no objection to the marketing of this criteria. The client can proceed with submitting pieces which communicate the listing and criteria.
It’s important to note that the naming convention mentioned above is to allow for pieces to be attached to a standardized email template and therefore will not have the indication and appropriate level of fair balance associated with it. If you wish to send an email with three different patient information tools for one brand across three indications, it may be worth considering a branded email. At this point, the email could contain the appropriate level of fair balance and allow for the identification of the therapeutic area within the naming convention. Note that should you take this route, the name of all attached tools should be included in the email submission.