Posted by Michael Wonder on 22 Mar 2021
PBAC publishes sham Public Summary Document for upadacitinib
22 March 2021 - The outcome section makes absolutely no reference to the issue at hand.
The Public Summary Document states that the the minor submission requested the PBAC review its November 2019 finding that upadacitinib is non-inferior to adalimumab in terms of effectiveness when used in the treatment of severe active rheumatoid arthritis.
This is not correct. The submission requested the PBAC review the statistical basis upon which a claim of superiority could be established using the inverse of the lower bound of the 95% confidence interval. If AbbVie wanted to establish a claim of clinical superiority over adalimumab, it would not have accepted the PBAC recommendation for upadacitinib and listed it on the PBS.
The outcome section of the Public Summary Document states that the PBAC requested corrigenda to the upadacitinib minutes and Public Summary Document from November 2019 be issued. This has not occurred. The Department of Health has removed all discussion on this issue without notification. This is unbecoming, deceptive conduct.
The Sponsor's Comment is compelling. It provides greater clarity on this issue that all of the commentary generated by the Department of Health. It is a sad day when one has to read the Sponsor's Comment section to get a clear, true and factual summary of the submission and its PBAC outcome.
