8 March 2021 - Can the Department of Health simply ignore PBAC advice?

In November 2020, the PBAC considered a resubmission from AbbVie for upadacitinib monohydrate (Rinvoq). The resubmission  requested the PBAC undertake a review of the statistical basis upon which AbbVie's claim of superior effectiveness for upadacitinib monohydrate versus adalimumab for the treatment of patients with severe active rheumatoid arthritis was not accepted.

The outcome for this resubmission (listed as an 'other matter' on the PBS website) is far from clear. While the outcome statement for the resubmission makes no reference to the PBAC's review of the statistical issue, it does state that the PBAC requested a corrigenda to the November 2019 Public Summary Document for upadacitinib monohydrate be issued.

A corrigendum (plural corrigenda) is "a thing to be corrected, typically an error in a printed book."  The official outcome statement for the resubmission makes no mention of what needed to be corrected.

The Public Summary Document for the resubmission for upadacitinib monohydrate is now available on the PBS website. The Department of Health has not produced a new discrete Public Summary Document for the resubmission; it has simply updated the Public Summary Document for the initial submission (November 2019).

The updated Public Summary Document does not include a corrigenda. The updated Public Summary Document makes no mention of the PBAÇ's consideration of a resubmission in November 2020.

Why isn't there a corrigenda? Did the PBAC withdraw its request for a corrigenda? This seems unlikely given the outcome statement for the resubmission has not been revised. Has the Department chosen to ignore or dismiss the PBAC's advice? One cannot dismiss this as a possibility. It seems rather odd that the Minister can hide behind PBAC advice when it suits him yet the Department can seemingly trash PBAC advice in a whim.

There is more to this story. Stay tuned.