Insights from the agenda for the November 2020 PBAC meeting

MAESTrO Database

26 August 2020 - New gene therapy from Novartis the standout submission from version 1.

The PBAC is scheduled to consider 49 submissions at its next scheduled meeting in early November. The agenda for the July 2020 meeting listed 60 submissions; the agenda for the November 2019 meeting listed 46.

The 49 submissions are comprised of:

  • 46 submissions for a PBS medicine/gene therapy
  • 2 submissions for a PBS medicinal preparation
  • 1 submission for an NIP vaccine
  • 36 initial submissions and 13 resubmissions
  • 28 major submissions and 21 minor submissions
  • 13 submissions for a new medicine/new gene therapy

Companies with multiple submissions include:

  • Novartis - 4 submissions
  • Janssen - 3 submissions
  • Sanofi - 3 submissions
  • Chiesi - 3 submissions

Insights

  • It will be interesting to see if the submission for filgotinib (Jyseleca) goes full term given the FDA rejected Gilead's new drug application for filgotinib earlier this month
  • Specialised Therapeutics is challenging the PBAC's decision for its medicine (fluocinolone acetonide (Iluvien). Fluocinolone acetonide was recommended in March this year but is not yet listed on the PBS.
  • Eli Lilly is persisting with galcanezumab with a resubmission for chronic migraine and a major submission for a new indication (episodic migraine)
  • The PBAC is scheduled to consider the first medicine that targets NRTK gene fusion; larotrectinib sulphate (Vitrakvi). The target patient population is patients with a solid tumour who are NTRK gene fusion positive (i.e tumour agnostic). A submission to the MSAC has already been made. One to watch closely.
  • Sanofi has lodged a major submission for MenQuadfi, its quadrivalent vaccine against meningococcal disease and more competition for Nimenrix (Pfizer)
  • BMS has made another attempt to secure a PBS listing for the Opdivo/Yervoy combination for the first-line treatment of patients with non-small cell lung cancer. This time the I-O combo is with two cycles of chemotherapy.
  • The PBAC will consider two technologies for patients with spinal muscular atrophy (nusinersen sodium (Spinraza) and onasemnogene abeparvovec (Zolgensma), albeit in different target patient populations.  It will interesting to see how the PBAC deals with Zolgensma which has a ticket price of $2.125 million/treatment in the US.
  • BioMarin has asked the PBAC to reconsider the use of sapropterin dihydrochloride (Kuvan) for maternal phenylketonuria. The agenda states the submission is a resubmission but we cannot find any evidence to indicate the PBAC has considered the use of sapropterin dihydrochloride in this patient population.
  • The PBAC will consider a major resubmission from Pfizer for tofacitinib citrate (Xeljanz) treatment of moderate to severe ulcerative colitis and to consider interchangeability advice. Definitely one to watch. Could it end up in court, like another Pfizer product Viagra did, so many years ago?
  • The resubmission from AbbVie for upadacitinib monohydrate (Rinvoq) for treatment of patients with severe active rheumatoid arthritis is somewhat hard to fathom given it has already been listed on the PBS for such use. We suspect it is related to Pfizer's activity for tofacitinib citrate (Xejlanz).
Michael Wonder

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Michael Wonder