Posted by Michael Wonder on 18 Dec 2020
Recommendations made by the PBAC - November 2020
18 December 2020 - The recommendations from the November 2020 PBAC meeting are now available.
By our calculations, the PBAC considered 63 submissions. This is not clearcut with so several 'other matters' being considered by the Committee. It is not clear whether these other matters arose from 'submissions' and whether there are for all intents and purposes 'outcomes'.
As usual, the PBAC considered a submissions that was not in the agenda; not even in the most recent version of the agenda dated the day before the meeting (3 November 2020).
These 63 submissions yielded 87 outcomes. The breakdown is as follows:
- Recommendations - 49 (56%)
- Rejections - 23 (26%)
- Deferrals - 14 (16%)
- No outcome (awaiting TGA outcome) - 1 (1%)
The number of recommendations is somewhat inflated due to the high number of recommendations for a few biosimilar medicines (Idacio, Mvasi and Remsima SC) insofar as these medicines were recommended for multiple diseases/indications.
Likewise the number of deferrals is somewhat inflated due to the deferral of adalimumab (Hadlima) for multiple diseases/indications.
There are multiple insights from the outcomes of the November 2020 meeting. Some of these are subtle/not obvious. These will be discussed in more detail in MAESTrO Daily in the coming days.
One fascinating outcome relates to the PBAC's consideration of AbbVie's submission for upadacitinib monohydrate (Rinvoq). The agenda states that the purpose of the minor submission was to request a review of the statistical basis upon which the claim of superior effectiveness versus adalimumab for the treatment of patients with severe active rheumatoid arthritis was not accepted.
The outcome of this submission (listed under 'Other matters') makes absolutely no reference to the statistical issue. Instead it notes that the PBAC reaffirmed its view that overall upadacitinib monohydrate, baricitinib and adalimumab are non-inferior in terms of effectiveness when used for the treatment of patients with severe active rheumatoid arthritis. The PBAC acknowledged that results from the SELECT-COMPARE trial demonstrated a statistically significant improvement of upadacitinib monohydrate over adalimumab. However, the Committee considered that the available evidence does not adequately support there being a clinically relevant difference in effectiveness between upadacitinib monohydrate and adalimumab.
Notwithstanding this, the PBAC has requested a corrigenda to the November 2019 UPA Public Summary Document be issued. Why issue a corrigendum/corrigenda if there is no change to the November 2019 outcome? Clearly something is missing here.
