19 July 2019 - The Public Summary Documents (first time rejections and deferrals) from the March 2019 PBAC meeting are now available.

The publication of the second tranche of Public Summary Documents from the March 2019 meeting has revealed the following insights:

The PBAC considered that the proposed place of pembrolizumab (Keytruda) in therapy for metastatic colorectal cancer, as a second-line treatment option, was incorrect. The PBAC, noting the Clinical Evaluation Report for the TGA and that 90.2% of patients in the key study (KEYNOTE-164), had failed at least two lines of prior treatment, advised that it would have been more appropriate to position pembrolizumab as a last-line treatment option. The PBAC advised that best supportive care or possibly trifluridine with tipiracil (Lonsurf) would be more appropriate comparators in a last-line setting.

The time horizon for the modelled economic evaluation of dabrafenib mesylate (Tafinlar) in combination with trametinib dimethyl suphoxide (Mekinist) has been redacted. This is interesting given the time horizon for the modelled economic evaluation of nivolumab (Opdivo) for the same disease, malignant melanoma, has not been redacted (30 year time horizon). It will be interesting to see if the process changes relating to the standardised redactions of PBAC Public Summary Documents will include the time horizons of modelled economic evaluations. One expects to see this issue will be raised at next week's PBS Process Improvements Webinar Information Forum.

Read PBAC Public Summary Documents