23 April 2021 - The outcomes from the March 2021 PBAC meeting are now available.

The presentation of PBAC outcomes has been updated to assist the public in finding specific outcomes. The outcomes have been consolidated into one document instead of being separated by different outcomes. 

The level of detail regarding PBAC's recommendations remains unchanged.

The PBAC considered 52 submissions at the March 2021 meeting.  The 52 submissions yielded 62 outcomes; some submissions had multiple requests and thus resulted in more than one outcomes. The breakdown of outcomes is as follows:

• 33 recommendations (53%)
• 24 rejections (39%)
• 3 deferrals (5%)

Two submissions (3%) did not result in an outcome. One submission was withdrawn (filgotinib maleate from Gilead for patients with rheumatoid arthritis) and the submission for roxadustat will be considered by the PBAC at a later date. The reason why it was not considered by the PBAC last month is not clear.

Of the high profile submissions:

• Risdiplam (spinal muscular atrophy) - recommended for three of the five patient populations. The PBAC rejected the requests for patients with type 3b and 4 (adult-onset) disease.
• Elexacaftor with tezacaftor and ivacaftor (cystic fibrosis) - deferred in order to allow engagement with Vertex Pharmaceuticals to align the proposed listing and associated costs and financial implications with the Managed Access Program and risk sharing agreements of the currently PBS listed cystic fibrosis transmembrane conductance regulator modulators, with the cost effectiveness link with these comparators having not satisfactorily been established by the submission.
• Pembrolizumab (colorectal cancer) - recommended for first-line use
• Atezolizumab (breast cancer) - rejected due to an uncertain clinical benefit. The PBAC wants to see additional clinical comparisons.
• Brolucizumab (age-related macular degeneration) - recommended on the fourth attempt
• Cabotegravir and rilpivirine (HIV infection) - the PBAC did not accept ViiV's cost benefit analysis
• Guselkumab (psoriasis) - the PBAC remains of the view that the comparator for guselkumab solution in pre-filled pens is the lowest cost PBS listed bDMARD and not guselkumab solution in pre-filled syringes
• Nivolumab and ipiliumumab (mesothelioma) - recommended for first-line and second-line use. Price reduction required.
• Ofatumumab acetate (multiple sclerosis) - recommended for on the basis of a comparison with the lowest cost PBS listed disease modifying therapy

The PBAC:

• Considered one submission that was not cited in the published agenda. The submission requested revisions to the existing PBS listings for enzalutamide and abiraterone acetate to allow their use prior to docetaxel in patients with metastatic castrate-resistant prostate cancer. It is unclear who prepared/lodged this submission.
• Considered submissions for 23 cancer medicine/patient population pairings; 11 were recommended, 11 were rejected and one was deferred.
• Considered at least 18 submissions with a CEA (21 patient population pairings); six were recommended, 14 were rejected and one was deferred. This estimate is very much preliminary as the economic evaluation in many submissions is unknown/unclear for now.  This analysis will be updated upon the publication of the Public Summary Documents.
• Considered one medicine for listing under a Managed Access Program; it was deferred
• 'Recommended' a price reduction for six medicines (five are cancer medicines)
• Recommended four medicines on the basis of a comparison with the lowest cost alternative
• Considered at least one medicine with a co-dependent technology; encorafenib was deferred pending an MSAC outcome. Pembrolizumab for colorectal cancer appears to be a co-dependent technology submission; the PBAC outcome makes no reference to the MSAC submission. The MSAC webpage for the application has not been updated for years.
• Recommended a risk sharing agreement for four medicines (five medicine/patient population pairings)
• Recommended the PBS listing of one new biosimilar medicine (teriparatide)

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