Hi Jennifer - as a follow-up to the March 2022 Q&A above, would data from a preplanned published extension study of a PM pivotal study be acceptable in the following circumstance: The Sponsor's product, drug A, has no restrictions on duration of use, it is used in combination with drug B, which is restricted to 1 year. The PM contains data at the end of year 1. The median follow-up of the extension study was 2 years. There were no amendments to the study design and it aligns with the PM in terms of the dosing, outcomes and patient population assessed. Understanding that the sponsor of drug B would not be able to leverage this data, would the sponsor of drug A be in a position to use the extension?

Hey @kshulist

The guidance does apply in this scenario. In addition to the considerations identified in your question, section 4.2 of the guidance relating to emphasis is also applicable. There should be no emphasis on burdens upon which the product has not demonstrated an effect and it should be part of a balanced presentation that includes burdens upon which the product has demonstrated an effect. Clear and prominent disclosure as per section 5.2 of the guidance will be required and this may include clarification of the indication even if it has already been included elsewhere.

As a reminder, PAAB will be starting to review under the new guidance starting February 19th.

Hello @au3010

We would need to see the whole piece to make an assessment. We suggest submitting for an exemption request.

Happy Friday @iainb

A symptom tracker that relates to a disease and not medication AE’s or medication outcomes, which contains no branding elements, could be considered exempt if there was no mention of treatment. If the tool speaks to treatment (even in an unbranded context) it would be subject to review. PAAB can provide an opinion if the piece is exempt. If you’ll want to proceed to approval if the piece is not considered exempt, please indicate this in the submission letter.

@Jennifer-Carroll Yes, it will be positioned in the context of patient counselling, as there is no other information of proper use of device in the PM (other than part 3)

Hello @natbourre

No, but the indication size should be proportional to the claim size Yes, it is acceptable to use the generic name.

Hey @mhe

The answer is nuanced and context driven. While dosing has clinical relevance for appropriate use of the product, the convenience of once daily dosing does not necessarily translate into a clinical outcome such as adherence, safety, and/or efficacy. As such, a claim of “convenient once-daily dosing” would not require a disclaimer of “Clinical significance unknown” but it would not be permissible to present it in a context that suggests unsubstantiated significance.

@admin We note that modifications to RMTs require PAAB resubmission. Would this still be the case for a product logo or legalese update that does not alter any of the other content in the RMT? If PAAB resubmission is required, is there a way for a reduced fee to be applied (we note that updated legalese or logos are not part of the criteria for "Minor Update" reviews).

Hey @laraholmes

It’s unclear what “in this respect” is referring to. “Open text fields” are “blank” by definition as the rep determines the copy. The restrictions for open-text fields are that the manufacturer has confirmed the reps are trained to limit open-text to transactional element with no therapeutic, product or service/tool being mentioned (see full advisory above). It may be beneficial to set up a clarification call so that we can better understand your question. Please reach out to admin to set up a call with me.

Afternoon @keoca

No that would not qualify. Specific timepoints must be clearly indicated as pre-planned.

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.