647 - In order to discuss switching patients from Product-A to Product-B within an APS, what is required for substantiation: a specific mention in the TMA/indication, Guideline recommendations, a head-to-head study? Also, does this substantiation need to appear in the APS itself?

  • According to section 3.1 of the PAAB Code, claims in advertising should be consistent with the Health Canada approved product monograph and labeling. This applies regardless of the specific reference provided to support the “switch” message. The acceptability of the “switch” message and the requirements for substantiation depend greatly on the type of claim made in the APS. Here are some examples that come to mind:
    • For a plea to consider using Product B in patients who were previously treated with Product A: If the indication specifies use in patient who were previously treated with Product A, then the indication alone would be adequate substantiation for this claim. If the indication is for a broader condition but does not specify use in patients previously treated with product B, then data would be required in the APS to quantify the product’s magnitude of effect in this specific patient population. Although a well-designed randomized controlled trial may be acceptable support if it meets all the evidentiary requirements in the PAAB code, the patient population studied, and data must be consistent with the TMA. If the subgroup exceeds the information in the TMA, we would suggest submitting the data to Health Canada as part of an SNDS. • For claims related to efficacy or safety of Product B in patients who were previously treated with Product A: Data would be required in the APS to quantify the magnitude of effect and must be consistent with the data/patient population in the TMA. •For claims related to place in therapy (i.e. Product A is recommended as first line therapy, Product B as second line therapy): This claim would require support from Canadian consensus guidelines and must be on-label (i.e. cannot exceed the product indication). In all cases, it is important to remember that the presentation should never disparage or unfairly attack a competitor’s product.