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Hi @Jennifer-Carroll,

Wondering if there had been any consideration to loop back with RAMQ on this guidance?
More specifically around "off-label" criteria, as I'm sure there are quite a few brands impacted, and the inability to even mention RAMQ for a tool.

Based on our reading of the document, even removal of discrete off-label criteria and maintenance of on-label criteria, wouldn't abide by their requests if all indications are presented.

Given these requests were provided directly to PAAB, we were wondering if there would be an opportunity to inquire with RAMQ whether there is anything that can be done? For example, is there something that could be said to just direct people to the website to find out more without implying coverage/criteria? Could a general statement of "For information on availability of formulary coverage in Quebec, please visit https://www.ramq.gouv.qc.ca/en/about-us/list-medications" (or something similar to add mention of potential criteria) be acceptable by RAMQ and PAAB?

We're open to additional thoughts around potential alternatives or next steps!

Thanks!

Hi @Jennifer-Carroll,

If we've already received full approval of our email template, but are now submitting a new APS (e.g., one-page PDF) that a client would like to be able to email out using that template, do we have to resubmit the template as a new file (even though nothing else has changed) or can we just include the what would be the "attachment name" in the new APS' submission cover letter?

Similarly, if one of the files that we had specified in the email template is expiring, but is renewed/updated slightly, do we have to resubmit the email template, or just include mention that it "replaces efile 9XXXX in the email template (efile 10XXXX)" in the renewal's submission cover letter? (given that we always confirm that APS will only be disseminated within their approval periods anyways)

Thanks very much in advance!