Hello @jen_antibody

Great question. To clarify, the request from RAMQ is to ensure that the coverage criteria are always clear and complete, so as not to suggest the indication is the coverage criteria (except where this is indeed the case). The document states: Coverage claims must be accompanied by reimbursement criteria (if applicable to the indications promoted in the piece). This means, that not all criteria are required in the piece. The discrete criteria which are not for the indicated population (i.e. off-label criteria), CAN be removed from the coverage criteria. All formulary claims, across Canada, for discrete off-label use would need to be removed, this is not exclusive to RAMQ. If there are additional indications for the product, which RAMQ does not cover, the formulary presentation/claim should be clearly limited to the indications with RAMQ coverage.

A statement similar to “For information on availability of formulary coverage in Quebec, please visit link” would still allude to RAMQ and be subject to the RAMQ request. However, to reiterate, the RAMQ request does not preclude the removal of off-label discrete coverage.

Happy Friday @palanski

A letter should be provided (a written statement within the initial cover letter or a separate letter) with a written statement confirming both aspects ((1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive). As inferred above, yes, this should be uploaded with the initial submission.

As the list of restricted words would not be exhaustive, it is not required as part of the submission.

Hey @SKW

As Patrick Massad is now the Commissioner, you should reach out to Yin Man, Senior Reviewer of Preclearance, to request opinion meetings. We have updated the website accordingly. Additionally, you are not restricted to the number of attendees from the Pharma company.

Thank you for the questions.

Hey @palanski and team

You are correct. Relative claims may appear as the main message (headline), when they include the absolute values. These should be presented as an integral part of the claim and should NOT be a different colour, style, size etc. All other aspects (quantification and qualification) you would normally include in the claim, still remain applicable.