Recommendations made by the PBAC - March 2022

PBAC

22 April 2022 - The recommendations from the March 2022 PBAC meeting are now available.

In the end, the PBAC considered 68 submissions. Three submissions were withdrawn:

  • Influenza vaccine (quadrivalent, adjuvanted) (Flucelvax Quad) - previously noted/advised
  • Venetoclax (Venclexta) - previously noted/advised
  • Ranibizumab (Susvimo) - not previously noted/advised. This is still not noted on the agenda as at 25 April 2022. Perhaps the submission has not been withdrawn. The outcome might be published in the coming days; stranger things have happened.

The Committee also considered three submissions that are not noted in the most recent version of the agenda for the March 2022 meeting:

  • Avelumab (Bavencio)
  • Larotrectinib sulphate (Vitrakvi)
  • Tepotinib hydrochloride monohydrate (Tepmetko)

The 68 submissions yielded 87 outcomes. The outcome count could increase in time as more information become available with the publication of the Public Summary Documents.

Some submissions are associated with multiple patient populations:

  • Larotrectinib sulphate was recommended for four patient populations
  • Somapacitan (Sogroya) and somatrogon (Ngenla) were both recommended for two patient populations

While one could argue that there are two outcomes for the submission for carfilzomib (one recommendation and one rejection), for the time being, we consider the submission to be associated with just one outcome.

The 87 outcomes are comprised of:

  • 68 recommendations (78%)
  • 16 rejections (18%)
  • 3 deferrals (3%)

The recommendation rate of 78% is the highest value we have recorded since the November 2019 meeting.

Recommendation rates are highly variable and are driven in part by the mix of submissions considered by the PBAC. A high recommendation rate may be due to a high proportion of 'minor' submissions that are generally more successful than 'major' submissions.  Higher recommendation rates may be due to more CMA type submissions that CEA submissions or fewer submissions for cancer medicines which are generally more challenging. We will have more to say on this in an coming issue of MAESTrO Daily.

Having said that, we also note that quite a few of the recommendations are associated with:

  • A risk sharing agreement
  • A price reduction (either offered by the sponsor or sought by the PBAC)
  • A comparison against the lowest cost comparator

We will examine this further at a later date.

In examining the outcomes from the March 2022 meeting, it has become apparent to us that PBAC submissions and their related outcome are becoming more complex/nuanced. We will have more to say on this in coming issues of MAESTrO Daily.

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Michael Wonder

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Michael Wonder