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519 - We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required?
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The coverage criteria is required when the advertisement includes details relating to coverage (such as formulary codes or eligibility criteria). Note that the presentation should be complete e.g. inclusion criteria, exclusion criteria, definitions, notes, etc. where applicable. This is indicated in the following PAAB advisory: http://www.paab.ca/resources/pdfs/declarations.pdf For pieces discussing provincial coverage in Quebec, you are required to disclose the criteria in ALL pieces that mention or alludes to the indicated use (even if a coverage codes or details are not provided). This is a request from RAMQ as per the following PAAB advisory: http://www.paab.ca/Advisory_regarding_use_of_RAMQ_in_APS.pdf Lowest level fair balance (and the indication) generally satisfies the safety disclosure requirements provided the stated coverage criteria do not include claims requiring middle or highest level fair balance as indicated in the following document. See the following link for tips on matching the fair balance level to the claim types presented in the piece: http://www.paab.ca/Tips_and_checklist_for_creating_and_selecting_fair_balance_(October_2015).pdf
