Suppose a product has an outdated indication (15+ years old), where the name of the disease itself has been superseded by new terminology and more current medical practice.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