Use of a MAIC study as a download in an APS
Would it be permissible to include a matching-adjusted indirect comparison (MAIC) study (between Product X and a competitor) as an attachment/download in an APS? Or would this type of publication automatically contravene PAAB code?
We note that 5.7.1 discusses how PAAB does not allow the use of PM-PM or study-study comparisons of efficacy and safety due to cross-trial differences. However, use of MAIC is shown to reduce or remove cross-trial differences.
Jennifer Carroll last edited by
In general, PAAB code section 5.7 requires that comparisons between products be supported by randomized, controlled, head to head trials. As noted in your question, code section 5.7.1 further addresses across TMA or across different study comparisons, which are also not acceptable. Indirect comparisons pose challenges with unaccounted factors, potential estimations, etc, that may materially affect the results. As such, the PAAB Code and Health Canada guidance on therapeutic comparisons, require head to head trials as opposed to indirect comparisons. While we do not have the specific MAIC for review, an MAIC study does not meet code section 5.7 requirements and would not be acceptable in advertising. PAAB offers an opinion service should the sponsor wish to present their position on the merits of their specific study.
@jennifer-carroll Thank you for the clarification, Jennifer!