28 July 2021 - The agenda for the November 2021 PBAC meeting is now available.

The agenda fails to note which initial submissions befit the four new categories despite the preamble on Page 1.

The PBAC is set to consider at least 47 submissions at its next scheduled (regular) meeting in early November.  The agenda may be expanded with the inclusion of additional items in week 8.

The 47 submissions are comprised of 45 medicines, one medicinal preparation and one NIP vaccine.

The agenda includes 13 submissions for a new medicine:

• Abrocitinib
• Amifampridine
• Apalutamide
• Avaglucosidase alfa
• Cemiplimab
• Gemtuzumab ozogamicin
• Gilteritinib fumarate
• Larotrectinib sulphate
• Mecasermin
• Sacituzumab govitecan
• Tepotinib hydrochloride monohydrate
• Trientine tetrahydrochloride
• Trientine dihydrochloride

The Committee will also consider a submission for a new combination product (cabotegravir sodium/Cabotegravir with rilpivirine) and five submissions for a new biosimilar medicine:

• Adalimumab (Hulio)
• Bevacizumab (Abevmy)
• Etanercept (Rymti)
• Insulin aspart (Truvelog, Truvelog Solostar)
• Rituximab (Ruxience)

The agenda includes multiple submissions for branded medicines for cancer:

• Acalabrutinib - multiple patient populations
• Apalutamide - two submissions
• Cemiplimab - two submissions
• Gemtuzumab ozogamicin
• Gilteritinib fumarate
• Larotrectinib sulphate
• Olaparib
• Pembrolizumab - two submissions
• Regorafenib monohydrate - resubmission for patients with colorectal cancer. Initial rejection was in 2014.
• Sacituzumab govitecan
• Tepotinib hydrochloride monohydrate

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