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Hi Danika - A Rapid Access Consult or written opinion might be of most value here, given the specific manufacturer and associated restrictions. PAAB will be able to advise on corporate claims, potential linkage issues, and if your specific product has any other considerations (e.g. Class A OUD products vs. Class B opioids).

Hi Adelaide - A 'Sell Sheet' is a broad term, that doesn't appear to be defined in Health Canada guidance documents. Advertising is classified by intent not format, and defined as anything with "the purpose of promoting the sale or disposal of a drug."

So if you're referring to a Pharmacy Order/Info Sheet (containing SKUs or prices not contained in the TMA), while this is still advertising, it may be treated differently if limited to logistical information alone.

s3.2.3.2 of the Health Canada Guidance states that any HCP material regarding opioid use is expected to undergo preclearance, where your specific content will be reviewed.

PAAB offers Written Opinion services, and now Rapid Access Consults, which may help guide development of your specific material.

Hi Danika - The RWE Guidance document does mention that Class B opioids and NOC/c products are not in scope, given APS for those products are limited to content from the TMA. However, other controlled drugs may be permitted to utilize RWE.
Also see Q&A 4213

Suppose a product has an outdated indication (15+ years old), where the name of the disease itself has been superseded by new terminology and more current medical practice.

Apart from going through a TMA update, is there any documentation or justification a Sponsor could provide to PAAB, in order to accept inclusion of new studies based on the newer disease terminology?

Hi Jennifer - Could a company produce an APS listing ongoing clinical trials, if these included approved products used in combination with investigational products? Would such an APS need to be an Editorial (s7.5.1) or could it be branded (s3.2.3)?

The Advisory on Provincial Formulary Statements distinguishes 'reimbursement criteria' from 'definitions and notes'. Per the RAMQ Advisory, coverage claims must be accompanied by 'reimbursement criteria'. Can you please confirm if the 'definitions and notes' portion of the RAMQ listings are required to appear in APS? These usually deal with initial authorizations and continuing requests, and are not technically criteria.

Thanks @Jennifer-Carroll
Are there any scenarios where directing HCPs to conference abstracts could be acceptable, in the absence of any product claims (s3.1.2ii)? i.e., in an Unbranded/Editorial APS, or through the use of the Attention Icon Guidance?

Hi Jennifer - to confirm the above, PAAB would review an on-label Abstract disseminated with (or linked to) advertising, and if there were no major concerns this could be an acceptable activity? Given the Abstract itself may not contain the detailed methodology required to conduct a review, would the Sponsor be able to provide supporting documentation such as the protocol, DoF, etc.?

As a follow-up to Q&A 577, we understand inclusion of the written statement “See Formulary listing for more information” would still be exempt for a simple “Now on Formulary” Email. Can you please advise if an indirect link to a general Formulary/Provincial homepage would maintain this exemption? The Sponsor has done their diligence in not directly linking to the therapeutic use, and the onus would be on the HCP to seek out the product information (if desired) through the Formulary.

Hi Jennifer - as a follow-up, would retargeting be more acceptable if limited to mobile users only? These devices are not shared, so we could more confidently ensure the ads are only served to the originally-validated HCP.

Hello - Based on the Guidance on Patient Reported Outcomes, are non-significant data presentations acceptable, if they are in a claim-neutral manner? In areas such as Oncology, treatments aim to have no worsening/deterioration in HRQoL vs. comparators. While this equates to a non-statistically significant difference, it is actually a positive clinical outcome.

Hi Jennifer - Under the Guidance documents pertaining to KM Analyses (Provision 8 ) and/or Real World Evidence (s1.4), would PAAB accept retrospective studies that use multivariate analyses to identify prognostic factors associated with Overall Survival?

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?

Ongoing Clinical Trials for investigational molecules

Hi Jennifer - As a follow-up to Q#223, can a branded APS contain a list of ongoing clinical trials for the approved product in combination with other investigational molecules? There would be no prominence on the unapproved products per s3.2.3, and disclaimers clarifying unapproved molecules/indications.

Does PAAB review HCP-directed advertising for Schedule C products (Radiopharmaceuticals)?

A sponsor has an existing Product-A indicated for Severe Condition-X. They will eventually have a new Product-B indicated for Mild Condition-X.
Question 1: Can they produce a pre-NOC editorial campaign discussing current treatment options for Mild Condition-X without alluding to future entrants?
Question 2: Could this be seen as off-label promotion of Product-A?

Hi Jennifer - We have some questions regarding PAAB-exempt name-only communications.

1. AskPAAB #137 on the original PMCQ site outlines that an HCP-directed exempt banner ad may link to the unedited PM. However the same question #137 on the PAAB Forum website has additional text, outlining that such a link would then render the banner ad no longer exempt. Can you provide clarification or advise which interpretation is correct?
2. AskPAAB #330 and #517 both deal with a 'Coming soon message', but give conflicting responses on whether this message is considered exempt. Can you provide clarification or advise which interpretation is correct?