18 December 2023 - Recommendations made by the PBAC in November 2023 relating to the listing of medicines on the PBS and vaccines on the NIP are now available.

In the end, the PBAC considered 42 submission requests. Two submissions will be considered at a future PBAC meeting: 

• Tislelizumab (Tevimbra) - non-small-cell lung cancer
• Tyrosine kinase inhibitors - chronic myeloid leukaemia 

The 42 considered submission requests yielded 58 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 (multiple requests):

• Adalimumab (Ardalicip) - multiple diseases
• Budesonide with eformoterol fumarate dihydrate (Bufomix Easyhaler) - asthma, chronic obstructive pulmonary disease
• Cytosine arabinoside with daunorubicin (nanoparticle, liposomal) (Vyxeos) - acute myeloid leukaemia
• Eltrombopag olamine (Revolade) - aplastic anaemia
• Fluticasone propionate with salmeterol xinafoate (Salflumix Easyhaler) - asthma, chronic obstructive pulmonary disease
• Ivacaftor (Kalydeco) - cystic fibrosis

The outcomes for the 42 considered submission requests are comprised of:

• 47 recommendations (81%)
• 10 rejections (17%)
• 1 deferral (2%)

The recommendation rate for this meeting (81%) is the highest recommendation rate in years. This rate is for considered submissions and thus does not include the 'outcomes' for withdrawn submissions.  This result depends at least in part on whether one included the outcomes (expressed as other matters) as actual outcomes. The outcomes for molnupiravir (Lagevrio) and nirmatrelvir and ritonavir (Paxlovid) have been included; the outcomes for dupilumab (Dupixent) and upadacitinib monohydrste (Rinvoq) have not.

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.

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

• A risk sharing agreement (n = 5)
• A comparison against the lowest cost comparator (n = 14)
• A price reduction (either offered by the sponsor or sought by the PBAC) (n = 25). This includes comparisons against the lowest cost comparator.

The following medicines/vaccines were recommended on a CEA basis:

• Abemaciclib (Verzenio) - price reduction required
• Cytosine arabinoside with daunorubicin (nanoparticle, liposomal) (Vyxeos)
• Difelikefalin acetate (Korsuva) - price reduction required
• Dostarlimab (Jemperli)
• Eltrombopag olamine (Revolade)
• Ivacaftor (Kalydeco)
• Lenacapavir sodium (Sunlenca) - price reduction required
• Mavacamten (Camzyos)
• Olaparib (Lynparza)
• Osimertinib mesylate (Tagrisso) - price reduction required
• Varicella zoster virus vaccine (adjuvanted) (Shingrix)

Insights:

• 11 of the 16 submission requests for a cancer medicine were recommended; 4 of the remaining 5 were rejected
• 11 of the 20 submission requests associated with a CEA were recommended; 8 of the remaining 8 were rejected
• While two submissions requests require substantial price reductions, another two were able to secure a price premium (one significant)
• The PBAC rejected the resubmission for semaglutide (Wegovy) for severe obesity. The PBAC nominated the
• facilitated resolution pathway for this item, given the high added therapeutic value of semaglutide and outstanding issues for resolution in defining the patients in whom treatment would reduce downstream consequences of obesity, be cost effective, and appropriate for the significant Government expenditur
• The PBAC has found at the current level of utilisation, dupilumab and upadacitinib monohydrate would not be considered cost effective at their current prices. It seems that this cannot be resolved until the current Deeds of Agreement have expired.