Introduction

The Pharmaceutical Benefits Advisory Committee (PBAC) concluded its December 2023 meeting with several key decisions that will shape the future of pharmaceutical treatments. Below we summarise these outcomes and highlight some potential future updates.

Noteworthy Decisions on Drug Listings

The PBAC meeting witnessed several crucial decisions on new drug listings and changes to existing ones. The recommendation list now includes Patisiran, a treatment for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with polyneuropathy.  This decision was based on the drug’s ability to delay disease progression and improve health-related quality of life. PBAC noted that in September 2023 it indicated that the economic model needed adjustments and that cost-effectiveness and financial figures were questionable. The sponsor’s updated proposal satisfied the economic model flaws.

Updates on Melatonin and Tyrosine Kinase Inhibitors

The PBAC revised its prior recommendation on using Melatonin to treat insomnia in Smith-Magenis syndrome (SMS) patients. They suggested that genetic testing could confirm SMS diagnosis and eliminate the need for a Risk Sharing Arrangement. Furthermore, they approved the restriction criteria for Tyrosine Kinase Inhibitors (TKIs). These include Asciminib, Dasatinib, Imatinib, Nilotinib, and Ponatinib, which are used to treat Chronic Myeloid Leukaemia (CML). The changes aim to align with current clinical practice.

Changes to Existing Drug Listings

The PBAC also recommended changes to the restriction levels of Upadacitinib, a drug used for treating severe active rheumatoid arthritis, from Authority Required (Written) to Authority Required (STREAMLINED). The committee noted that the market for Upadacitinib had stabilised and would not drive growth in the rheumatoid arthritis market.

Recommendations for Testing Methods

The committee also recommended changes to the restriction criteria for several drugs (including alectinib, brigatinib, and ceritinib) used in treating non-small cell lung cancer. These changes include the addition of next-generation sequencing gene panel testing as an eligible testing method for Pharmaceutical Benefits Scheme (PBS) subsidy in addition to fluorescence in situ hybridisation (FISH) testing.

Deferred Decisions

Not all decisions were finalised at the meeting. The PBAC deferred making a recommendation for an expanded listing of Nivolumab and Ipilimumab, as well as Pembrolizumab, for current or future Therapeutic Goods Administration (TGA) registration. These decisions were deferred to allow for further consultation with the sponsor and the Department.

Review of PBS Prescribing

The PBAC also reviewed the prescribing of PBS-listed medicines by nurse practitioners and endorsed midwives. The committee noted that a review is being undertaken by the Department on this matter, with an open consultation planned for early 2024. The PBAC and Department aim to collaborate with health professional groups to develop general principles for determining prescriber types for PBS listings.

Ultimately, the most recent PBAC list is lower in length when compared to the July 2023 list. It is important to note the numerous recommendations included. This indicates that Australia conducts ongoing, thorough evaluations. The aim is to ensure everyone has access to effective and affordable healthcare.