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Hey @dlew
Coverage claims may be considered in HCP APS. Patient information should not contain promotional claims but formulary information may be considered. Please see our patient information guidance. HCP claims about “cost” should be factual and complete. A claim of “at zero additional cost for most patients” would be a hanging comparison and would need to clearly state versus what and be supportable across all public and private payers. Remember that formulary bodies have requested that messaging around coverage be limited to statements of coverage and not promotional messaging around “savings”. Additionally, messaging around cost should be clear about what costs (e.g. drug acquisition costs, mark-up, dispensing fee, etc.).

Private coverage claims can be supported by independent third party data from an established company who assess’ market access.

It’s Friday @Agency @Manufacturer and PAAB wants to send you into the weekend with some exciting news: The NEW Creative Imagery in Advertising Advisory is NOW live!

After months of insightful and collaborative discussions, we’re excited to finally announce PAAB’s new advisory on the use of creative imagery in pharmaceutical advertising. Industry has asked for clarity, and we hope this document provides that clarity you’ve been waiting for, or at the very least, provides a stronger framework to evaluate creative ideas with your teams.

Note that this is not the finish line. This is a starting point to continue to grow and evolve with the ever-changing landscape, to meet the needs of healthcare professionals and patients.

We’d like to extend our gratitude to all the industry members of the Creative Committee who took time to share challenges, discuss the advertising landscape, listen to the regulatory concerns and work collaboratively with PAAB to refine the creative imagery discussion.

Special thanks to Mike Spelay (bMod), Andy Leeson (Wellworth and Best), and Konstantine Polanski (Point05 Health), for driving the revisions from the first draft document and creating meaningful examples. Thank you to the bMod team for generating creatives to help capture the principles outlined throughout the document.

We look forward to implementing these new approaches with you and continuing the conversations.

Hey @ALee

Please see Q&A 223 & Q&A 713. These were found by searching “ongoing”. If you select “in titles and posts” you may find additional past questions relevant to your question.

Hey @megancouture

In the context of a general question, there are cases where company-generated calculations may or may not be acceptable. For the specific examples presented, a review of the study design/statistical analyses/results would be considered in the assessment. We recommend considering the following Code sections:

• Code section 5.8 - Methodologies, endpoints and independent review. To be considered as evidence, clinical studies must use established research methodologies and validated endpoints. To aid in the assessment of these study parameters, PAAB looks for evidence that the full study results have been subject to independent review, such as that found by achieving the publishing of study results, including statistical analyses, in a peer-reviewed journal

• For the second example, we’d also advise to consider Code section 4.2.3 (principles of relative risk reduction [RRR] and absolute risk reduction [ARR]) and Code section 5.9 (statistical significance required for evidence).

Hey @Maryssa

Any ad which appears in the consumer space (even when limited through targeting based on interests or profession), are subject to the direct-to-consumer advertising regulations. Link to therapeutic use through study design, name, description, fair balance, or any other form, would not be acceptable since it would contravene Section C.01.044 of the Food and Drugs Act and Regulations which does not permit advertising of prescription medications to the general public beyond name, price and quantity.

Hello @adelaidebaker

Per Health Canada’s Terms and Conditions for Class B opioid products, advertising is restricted to messaging verbatim from the Health Canada approved Terms of Market Authorization. While “market research” and “claims” are broad and unclear, it is unlikely that market research can be used in advertising. If you have a specific case in mind, we invite you to submit for an opinion where additional context can be provided.

Good Morning @palanski

There is not a part of the Code that states that it’s “not required”. Per the above response “. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece.” Code section 6 (Patient Information) states “Company controlled or prepared branded patient information is information that contains non-promotional material that is consistent with, and in addition to, the Health Canada approved patient information (e.g. the consumer information section of the product monograph, patient insert, approved product labelling)” and “All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims”. While other sources may support disease understanding, they do not act as sources of evidence for promotional claims which is the case in HCP advertising and therefore requires the source of evidence to be provided to the HCP for transparency. PAAB does not discourage inclusion of reference lists within patient pieces, it is simply not a requirement of the Code.

Please see Q&A 266. See also PAAB Code 1.5.D which states “Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages” for exemption considerations. The mentioned claim would not be exempt.

Hi @laraholmes

We can’t speak to specific reviews or the context or understanding of the website you’re referring to. In the absence of context required to provide specific direction, as a general rule of thumb, when you link advertising and non-advertising, everything becomes advertising and should meet the advertising regulations. PAAB can assist during the reviewer process to help create separation between branded and unbranded content as well as links to additional educational materials.

Hey @cscholes

Claims within advertising for biosimilars must meet the same rigors of the Code as other products. Studies from outside of the TMA must be consistent with the TMA. They must also meet PAAB Code requirements for evidence e.g. well-designed, published, peer-reviewed, statistically supported claims based on predefined endpoints, on label, etc.). If you’re not certain if a specific study meets those requirements, we encourage you to submit for an opinion review. Please be specific about how you’d like to use the study in order to receive the most comprehensive opinion.

Hi @Danielle

Section 1.1.4 Endpoints/ Outcomes of the Guidance on Real-World Evidence states “Endpoints/Outcomes must be “consistent with” (though not necessarily “the same as”) those in the TMA. Regardless of whether the evidentiary basis for the presentation is RWE/RWD or an RCT, endpoints are not generally limited to those explicitly included within the TMA. Though the approach for RWE/RWD mirrors that for RCTs in this respect, the following examples are intended to clarify questions received during the consultation process.” You can review the examples in the linked document. Assessment of “consistent with” is made in the context of the combination of the endpoint, TMA and the therapeutic area. The submitter should provide authoritative support within the submission, to support that the endpoint is consistent or similar to those in the TMA and that it is a recognized endpoint within the therapeutic area.

Hey @mef

Thank you for flagging this. We've discussed the matter with the review team to ensure alignment and are updating both internal and external guidance documents for clarity. In most cases, study design footnotes may appear outside the box.

Good Morning @dmauri

This is a specific review question. Please submit the guidelines and proposed product claims. This can be done in a full submission or an opinion if you’d like further clarification prior to building out tools.

Hey @Username
“Schedule 2” is a bit broad. There are many factors and combinations to consider. Could you provide the product or therapeutic class, or Federal drug schedule (see link) to help narrow down the response. Alternatively, if you’re not comfortable sharing in a public space, you can email review@paab.

Hello @Jennifer-Thomson
It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval.

Hey @ALee
The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included.

Hello @manufacturer @agency

Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact.

What's changing?
PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact.

Click here to more about why, new form requirements, and what this means for the review process.

Question? Post below and we'll get back to you.
Thanks
PAAB

Hey @ALee
Not at this time based on PAAB code section 3.1.2 but something we can keep on a list to explore in the future.

Good morning, @Username

Comparative data remains subject to the guidance for evidentiary basis to support comparative claims. As noted above, consideration may apply when the study can be demonstrated to be the basis for approval of the biosimilar. A study that is NOT part of the basis for approval and completed post approval, should meet the standards for high quality evidence (i.e. pre-defined statistically significance endpoints).

Good morning, @copycallosum

In theory, this sounds like an acceptable activity.