This article provides an update to our series on real-world data ("RWD") and real-world evidence ("RWE") to reflect recent developments related to the Pharmaceutical Advertising Advisory Board (PAAB) and the Canadian Agency for Drugs and Technologies in Health (CADTH). On October 13, 2023, PAAB announced that the draft Code of Advertising Acceptance ("Code") and Guidance on Real-World Evidence/Data ("Draft Guidance") have been forwarded to Health Canada for consultation. Meanwhile, CADTH has announced that it is establishing an industry task force on RWD for Post-Market Drug Evaluations.

As a refresher, RWD is data relating to patient status and/or the delivery of healthcare routinely collected from a variety of sources in real-world settings (e.g., patient support programs, patient registries). RWE is the evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.

RWE can be used to help fill evidentiary gaps for underrepresented patient populations (e.g., children, the elderly, pregnant women, underserved and understudied communities, or patients with a high burden of multimorbidity), or where the generation of randomized controlled trial data is not feasible (e.g., evaluation of drugs for rare diseases or leveraging larger sample sizes and longer follow-up periods than are typical in randomized controlled studies). Accordingly, the integration of RWD/RWE in advertising and health technology assessments may help to improve the accessibility of certain drugs.

PAAB

As noted above, updates to PAAB's Code and the Draft Guidance are currently under review by Health Canada.

PAAB's current Code and guidelines permit inclusion of RWE findings in advertising only when they are replicated in randomized controlled trials. This approach to RWE is restrictive. If it needs to exist in the form of gold-standard results derived from randomized controlled trials, RWE cannot truly contribute new information.

The Draft Guidance reflects changes to PAAB's approach on the use of RWE in advertising. The Draft Guidance notes that healthcare professionals do not typically have the luxury of deferring therapeutic decisions until the availability of the highest possible quality of evidence. Greater permissibility of RWE in advertising to healthcare professionals may help to address this by facilitating the dissemination of recent research findings for clinical decision-making as it becomes available.

The Draft Guidance provides nine criteria to be used to ascertain whether RWE meets basic requirements for validity and relevance, including consistency with the Product Monograph. It also provides formatting standards for the inclusion of RWE in advertising, to ensure healthcare professionals can easily differentiate between presentations of RWE and other evidentiary forms, such as randomized controlled trials.

We discussed these principles in detail in our previous article, "PAAB Publishes Draft Guidance Document on Use of Real-World Evidence in Advertising".

CADTH/INESSS

PAAB's Draft Guidance and updates to its Code coincide with recent guidance on reporting RWE from CADTH, in collaboration with Health Canada and the Institut national d'excellence en santé et en services sociaux (INESSS). According to CADTH, the guidance harmonizes principles for the use of RWE in regulatory approval and health technology assessments ("HTA") in Canada by CADTH, Health Canada, and INESSS and prioritizes transparent reporting while maintaining alignment with international standards.

In fact, PAAB's Draft Guidance encourages manufacturers to assess studies according the CADTH national reporting standard where appropriate, particularly regarding criteria relevant to the research question and methodology.

In August 2023, CADTH announced that it is establishing an industry task force that will build on its guidance to provide advice on the use of industry-generated RWD in its Post-Market Drug Evaluations Program. The program provides evidence to federal, provincial, and territorial decision-makers about drugs that have been approved and are broadly available to people in Canada. According to CADTH's announcement, many drug manufacturers have indicated interest in sharing the RWD that they collect with HTA agencies and decision-makers.

The task force intends to identify opportunities and barriers for using RWD in the Post-Market Drug Evaluations Program. The group will collaborate to develop an option paper for CADTH to guide on best practices and approaches for employing RWD in a way that mitigates risks.

We discussed the CADTH guidance document in our previous article, "CADTH Publishes Guidance on Reporting Real-World Evidence".

Our Life Sciences team has significant expertise advising the pharmaceutical industry on advertising compliance, health product regulatory submissions and other matters and is available to consult on the guidance documents and related developments.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.