26 November 2021 - More insights from the MAESTrO Team.

The agenda for the next scheduled PBAC meeting, (we are already up to version 2), reveals some interesting insights. The common theme is change.

• The agenda includes just one medicine for patients with cardiovascular disease. Gone are the days when the PBAC's agenda was replete with medicines for patients with hypertension, angina pectoris, myocardial infarction and heart failure. This appears to be a clear decline rather than just a one off event.
• The agenda includes submissions from two new first time applicants; Cipla and Sobi.
• The emergence of some many new applicants has resulted in a subtle changing of the guard. Gone are the days of the agenda being dominated by big players preparing/lodging several submissions. To date, Novartis, Janssen, MSD & Pfizer all have just two submissions currently in play. In contrast, Teva Pharmaceuticals and Chiesi each have three submissions up for review.
• The agenda includes submissions for 18 new medicines.  This is the highest number of new medicines to be considered by the PBAC since the November 2017 meeting (n=22).  This is a sign that the innovative pharmaceutical industry has not 'given up' on the PBAC/PBS.
• Of the 18 new medicines; two are for diseases/conditions that do not have PBS listed alternatives. The two medicines are sebelipase alfa (Kanuma) for patients with patients with infantile onset lysosomal acid lipase deficiency (Wolman disease) and zanubrutinib (Brukinsa) for patients with Waldenström's macroglobulinaemia. The PBAC rejected the initial submission for zanubrutinib in July.
• We estimate there are 19 parallel process submissions; the list includes a submission for a new combination product. At least one medicine in this list has also not yet been approved by the US FDA.