17 December 2021 - The recommendations from the November 2021 PBAC meeting are now available.

In the end, the PBAC considered 49 submissions. Two submissions featured in the published agenda were not considered and have been rescheduled for review at the March 2022 meeting:

• Abrocitinib (Cibinqo)
• Cemiplimab (Libtayo)

The PBAC considered one submission that did not appear in any of the 11 published agendas; dapagliflozin propanediol monohydrate (Forxiga).

The Committee also reviewed recommendations made previously that have not implemented; many were rescinded. A few have been extended for 12 months:

• Aripiprazole monohydrate (Abilify Maintena)
• Certolizumab pegol (Cimzia)
• Influenza vaccine (trivalent) (FluZone High-Dose)
• Ibrutinib (Imbruvica)  

The 49 submissions yielded 89 outcomes. Several submissions, especially those for new biosimilar medicines, have multiple requests for multiple diseases/patient populations. The PBAC considered the use of larotrectinib sulphate (Vitrakvi) in three discrete patient populations. The PBAC considered a submission for acalabrutinib for two diseases (four patient populations). As such, the number of outcomes (outputs) is greater than the number of submissions (inputs).

The 89 outcomes are comprised of:

• 58 recommendations (65%)
• 24 rejections (27%)
• 7 deferrals (8%)

Insights

• Of the 16 submissions for a new medicine, five were recommended (apalutamide, cabotegravir, cemiplimab, gemtuzumab ozogamicin, siltuximab)
• Of the 16 submissions for a cancer medicine (new medicine or new indication), five were recommended. We have deemed AL amyloidosis not to be a cancer.
• Of the 17 submissions that sought a listing on a CEA basis, only five were recommended. These are preliminary findings as for some submissions it is unclear what type of economic evaluation was used.
• The PBAC wants to see a (substantial) price reduction for at least six medicines; five of these are cancer medicines. This includes sacituzumab govotecan (Trodelvy) for breast cancer. This does not include tepotinib hydrochloride monohydrate (Tepmetko) - the Committee wants to see a cost minimisation analysis versus pembrolizumab.
• Three medicines was recommended on the basis of a comparison with the lowest cost alternative (fluticasone furoate with vilanterol trifenatate and umeclidinium bromide, ixekizumab, risankizumab)
• Three submissions were associated with a request for a price premium; one was recommended (cabotegravir and rilpivirine)
• The PBAC considered five submissions for a new biosimilar medicine; all were recommended
• According to the PBAC, regorafenib monohydrate (Stivarga) is toxic; at least for patients with colorectal cancer. An interesting expression given the Committee is not a regulator.
• Those who think that the PBAC is ready and willing to accept the use of real world data (evidence) to support clinical claims need to look at the outcome for cladribine for a dose of reality.

More insights from the 2021/3 PBAC meeting in future issues of MAESTrO Daily.

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